Chronic Critical Limb Ischemia and

diabetic lesions:

A review of the literature and

analysis of a cohort of 126 patients

  1  
1, Introduction

2, Pathophysiology of Chronic limb ischemia

3, Clinical presentation of chronic severe limb

ischemia

4, Definition of chronic severe limb ischemia

and clinical classification

5, Risk factors for chronic limb ischemia

6, Diagnostic tools

A, Laboratory
B, Radiological (invasive and noninvasive)

7, Original study

A, Study questions
B, Methods
C, Results
D, Discussions
E, Conclusion

8, Summary and general conclusion

  2  
INTRODUCTION

The   chronic   critical   limb   ischemia   is   a   clinical   stage,   in  

which   the   affected   lower   limbs   are   in   danger   or   they  
thrive   to   live,   which   is   generally   a   consequence   of  
atherosclerosis   obliterans   but   thromoangitis   obliterans  
can  also  lead  to  CLI.    
 
CLI the hallmark of peripheral arterial occlusive disease
is an issue of supply vs. demand, that is, inadequate
blood flow to supply vital oxygen demanded by the limb,
critical limb ischemia (CLI) occurs after chronic lack of
blood supply, setting off a cascade of pathophysiologic
events that ultimately lead to rest pain or trophic lesions
of the legs, or both. Thus, CLI is considered the “end
stage” of peripheral arterial disease (PAD).  

CLI is not to be confused with acute occlusion of the

distal arterial tree, but rather a disease process that occurs
in a chronic setting of months to years and, if left
untreated, ultimately leads to limb loss secondary to lack
of adequate blood flow and oxygenation through the
distal extremities.

According to the recent consensus CLI occurs 2% in

persons at 50 or more than 50 yrs. who is already
suffering from a Peripheral Arterial Occlusive Disease
(PAOD).

There will be approximately between 500 and 1000 new

cases of CLI every year in a European or North
American population of 1 million.

  3  
Patients with chronic CLI have 20% mortality in the first
year after presentation, and the little long-term data that
exists suggests that mortality continues at the same rate.

The short-term mortality of patients presenting with

acute ischemia is 15% to 20%. Once they have survived
the acute episode, their pattern of mortality will follow
that of the claudicant or patient with chronic CLI,
depending on the outcome of the acute episode (Hirsch,  
Haskal  et  al.  2006;  Norgren,  Hiatt  et  al.  2007).  

PATHOPHYSIOLOGY  OF  CHRONIC  LIMB  ISCHEMIA  

 
Pathophysiology  of  CLI  is  a  chronic  and  complex  process,  
which   involves   macro   and   micro   vascular   systems   as  
well  as  the  surrounding  tissues.  
 
CLI   is   usually   caused   by   obstructive   atherosclerotic  
arterial   disease,   however   it   can   also   be   caused   by  
atheroembolic   or   thromboembolic,   vasculitis,   in   situ  
thrombosis   related   to   hypercoagulable   states,  
thromboangitis   obliterans,   cystic   adventitial   disease,  
popliteal   entrapment   or   trauma.   (Hirsch,   Haskal   et   al.  
2006)  
 
CLI   occurs   when   the   arteries   are   stenosed   or   occluded,  
which   impairs   the   blood   flow   to   an   extent   where,  
despite   compensatory   mechanisms   such   as   collateral  
formation,   nutritive   requirements   of   the   peripheral  
microcirculation   cannot   met.   This   usually   results   from  
the  presence  of  multilevel  disease  or  occlusion  of  critical  
collaterals.  (1992)  

  4  
As   a   result,   the   arterioles   in   patients   with   CLI   try   to  
vasodilate  to  the  maximum  and  stays  insensitive  to  pro  
vasodilatory  stimuli.  This  phenomenon  is  referred   to  as  
vasomotor   paralysis,   which   is   considered   to   be   the  
result   of   chronic   exposure   to   vasorelaxing   factors   in  
patients  with  diseases  vessels.    
 
Moreover   the   blood   vessels   in   patients   with   CLI   have  
decreased  wall  thickness,  decreased  cross-­‐sectional  area  
and   a   decreased   wall   to   lumen   ration   compared   with  
controls.(Coats   and   Wadsworth   2005;   Tang,   Chang   et   al.  
2005).  
 
Further,  these  changes  contribute  to  edema,  which  is  a  
major   concern   in   these   patients.   In   addition,   patients  
with  CLI  prefer  to  hold  their  limbs  in  dependent  position  
to   alleviate   ischemic   rest   pain,   combined   with   the  
impaired   vasomotor   control,   this   leads   to   further  
aggravation   of   the   edema,   which   increases   the  
hydrostatic   pressure   with   in   the   distal   portion   of   the  
limb,   compressing   already   compromised   capillaries   and  
impairing  diffusion  of  nutrients  to  the  tissue.(Coats  and  
Wadsworth  2005)  
 
On  the  other  hand,  micro  vascular  dysfunction  occurs  in  
addition   to   macro   vascular   changes.   Chronic   ischemia  
from   macroscopic   disease   leads   to   endothelial  
dysfunction.   This   endothelial   dysfunction   of   cells   helps  
in   the   formation   of   micro   thrombosis   within   the  
capillaries  and  exacerbates  edema  formation.  

  5  
Furthermore,   endothelial   results   in   increased   free  
radical  production,  inappropriate  platelet  activation  and  
the   adhesion   of   leukocyte   leads   to   micro   thrombi  
formation.  The  end  result  is  that  tissue  oxygen  exchange  
at   the   capillary   level   is   impeded   and   less   effective.    
(Coats  and  Wadsworth  2005)  
 
CLINICAL  PRESENTATION  OF  CHRONIC  CLI    
 
Patients  with  chronic  CLI  usually  presents  with  limb  pain  
at  rest,  with  or  without  trophic  changes  or  tissue  loss.  
 
Rest   pain:   Ischemic   rest   pain   is   described   as   a   severe  
pain   that   occurs   in   the   toes   or   in   the   area   of   the  
metatarsal   heads.   Occasionally,   it   occurs   in   the   foot  
proximal   to   the   metatarsal   heads,   and   it   is   commonly  
associated   with   systolic   arterial   pressures   below   50  
mmHg   and   toe   pressures   below   30   mmHg.(Cranley  
1969)  
 
Usually   patients   encounter   the   pain   typically   at   night,  
when  the  limb  is  no  longer  in  dependent  position,  but  in  
severe  cases  it  can  be  continuous.    The  pain  often  wakes  
up  the  patient  at  night  and  forces  them  to  get  up  or  take  
a  short  walk  around  the  room.    Partial  pain  relief  may  be  
obtained   when   the   legs   are   in   dependent   position,   on  
the  other  hand  elevation  of  the  limb  above  or  horizontal  
position  and  cold  aggravates  the  pain.    
 
 

  6  
Patient   often   sleeps   with   their   ischemic   leg   dangling  
over  the  side  of  the  bed,  or  sitting  in  an  armchair,  which  
augments   the   hydrostatic   pressure,   and   as   a  
consequence   ankle   and   foot   edema   develop.   (Norgren,  
Hiatt  et  al.  2007)  
 
Ischemic   rest   pain   should   be   differentiated   from  
neuropathic   pain,   however   the   later   will   manifest   as  
severe,  sharp,  shooting  pain  usually  most  pronounced  at  
the   distal   part   of   the   extremity,   with   episodes   lasting  
from  minutes  to  hours  associated  with  constant  diffuse  
pain  remaining  in  between.(Norgren,  Hiatt  et  al.  2007)  
 
Trophic  changes:  Trophic  changes  of  the  legs  manifest  in  
the   form   of   ischemic   ulcers   or   gangrenes.   Normally  
trophic   changes   are   associated   with   ischemic   rest   pain  
except   in   patients   suffering   from   diabetes   because   it   is  
masked  by  the  peripheral  neuropathy.  
 
           PRESSURE  ULCERS  IN  DIABETIC  PATIENTS  

  7  
Ischemic  ulcers:   Ischemic   ulcers   often   initiated   as   minor  
traumatic   wounds,   in   which   the   healing   process   is  
retarded   due   to   the   insufficient   blood   supply   to   meet  
the  increasing  demands  of  the  healing  tissue.(DeWeese,  
Leather  et  al.  1993)  These  ulcers  are  often  pain  full  and  
associated   with   other   manifestations   of   chronic   critical  
limb  ischemia  such  as  ischemic  rest  pain,  pallor,  alopecia  
of  the  legs,  hypertrophy  of  the  toenail  buds.  
 
Ischemic   ulcers   typically   occurs   in   the   pressure   points   of  
the   legs   such   as   malleolus,   tips   of   the   toes,   metatarsal  
heads,  inter  digital  spaces  and  under  the  heels.    
 
                                                                   MIXED  ULCERS  

 
 
They   are   usually   dry   and   punctate.   However   ischemic  
ulcers   should   de   distinguished   from   chronic   venous  

  8  
insufficiency   and   peripheral   neuropathy,   which   are   the  
other  major  causes  of  the  leg  ulcers.  
 
                                                                       VENOUS  ULCERS  

 
 
 
 
Gangrene:   Gangrene   is   characterized   by   cyanotic,  
aesthetic   tissue   associated   with   or   progressing   tissue  
necrosis,  it  occurs  when  the  arterial  blood  supply  fails  to  
satisfy   the   basic   metabolic   demands   which   is   required  
for   the   viability   of   the   tissue.(DeWeese,   Leather   et   al.  
1993),  It  can  be  described  as  either  dry  or  wet  gangrene.  
 
The   dry   gangrene   is   characterized   by   hard,   dry   texture,  
usually   seen   in   the   distal   aspect   of   the   toes,   with   a   clear  
demarcation  between  the  viable  and  the  necrotic  tissue.  

  9  
The   various   causes   of   foot   and   leg   ulcers   are   listed  
below.  (Norgren,  Hiatt  et  al.  2007)  
 
           
         Origin              Cause              Location              Pain   Appearance          Role   of  
Vascularisation  

Arterial   Severe  PAD   Toe,Foot,   Severe   Various   Important  

Burger’s   Ankle   shape,   Pale  
disease   base,  Dry  

Venous   Venous   Malleolar,   Mild   Irregular,   None  

insufficiency   esp.  Medial   pink   base,  
moist  

Mixed   Venous   Usually   Mild   Irregular,   If  non  healing  

insufficiency   Malleolar   pink  base  
+  PAD  

Skin  Infract   Systemic   Lower   third   Severe   Small   often,   None  

disease,   of   leg,   multiple  
embolism   Malleolar  

Neuropathic   Neuropathy   Foot/plantar   None   Surrounding   None  

from   surface,   callus,  often  
diabetes,   associated   deep  
Vitamin   deformity   infected  
Deficiency  

Neuro   Diabetic   Common   to   Reduced   As  arterial   AS  arterial  

ischemic   neuropathy   ischemic   and   due   to  
+  ischemia   neuro   neuropathy  
ischemic  

  10  
                                            DRY  GANGRENE  OF  THE  TOE  

 
 
 
 
This   form   of   gangrene   is   more   common   in   patient’s  
atherosclerotic  disease  and  can  ensue  in  embolization  to  
the   toes   or   forefoot.   Sometimes   the   involved   digit   can  

  11  
go   for   auto   amputation   without   further   proximal  
progression   of   the   gangrene   and   it   can   heal   slowly   by  
itself,   if   there   is   a   sufficient   blood   supply   to   help   the  
healing  process.  
 
Wet  gangrene  is  characterized  by  its  moist  appearance,  
oedematous,   blistering   sometime   associated   with  
severe   inflammation.   It   is   a   true   emergency,   especially  
in   diabetic   patients.   It   is   often   associated   with  
underlying   infection,   which   can   compromise   the   vital  
prognosis,  if  adequate  steps  are  not  taken  at  right  time.  
Usually   treated   by   antibiotics   and   emergent  
debridement  of  the  affected  tissue  results  in  healing.  If  
the   wet   gangrene   is   very   extensive,   which   requires  
urgent   amputation,   with   revision   to   below   or   above  
knee  amputation  72  hours  later.            
 
 
     
DEFINITION AND CLASSIFICATION OF CLI  

The term ‘’ critical limb ischemia ‘’ is a clinical term

used to describe the patients which chronic
ischemic rest pain, requiring regular adequate
analgesia for more that 2 weeks, with or without
ulcers or gangrene attributable to objectively proven
arterial occlusive disease, with an ankle systolic
pressure below 50 mmHg or a toe systolic pressure
below 30 mmHg.

  12  
The various classification of CLI are described
below (Wolfe and Wyatt 1997)
 
Fontaine  Classification        
Stage  3                                                                                  Ischemic  rest  pain  caused  arterial  disease            
Stage  4                                                                                  Ulcerations   and/   or   gangrene   caused   by   arterial  
disease    
 
 
    Rutherford  Classification    
Grade   Category   Clinical  description   Objective  criteria  
II   4   Ischemic  rest  pain   Resting   AP   <   40mm   Hg,   flat   or  
  barely   pulsatile   ankle   or  
     
metatarsal  PVR,  TP  <  30  mm  Hg  
 
III                           5   Minor   tissue   loss   –   nonhealing  
Resting   AP   <   60   mmHg,   ankle   or  
ulcer,  focal  gangrene  with  diffuse   metatarsal   PVR   flat   or   barely  
 
pedal  ischemia  
pulsatile,  TP  <  40  mmHg  
 
 
 
 
Major   tissue   loss   –   extending  
Same  as  category  5  
6   above   TM,   functional   foot   no  
longer  salvageable  

AP-­‐ankle  pressure,  PVR  –  pulse  volume  recording,  TP  –  toe  pressure,  TM  –  transmetatarsal.  
 
 
 
International  Vascular  Symposium  Working  Party  Definition        
1. Severe   rest   pain   requiring   opiate   analgesia   for   at   least   4   weeks                                                    
and  either:  
2. Ankle   pressure   <   40   mmHg                                                                                            
or  
3. Ankle   pressure   <   60   mmHg   in   the   presence   of   tissue   necrosis   or   digital  
gangrene  
 
 
 
First  European  Working  Group  Definition        
1. Severe   rest   pain   requiring   opiate   analgesia   for   at   least   2   weeks                                                              
or:  
2. Ulceration   or   gangrene                                                                                            
and:  
3. Ankle  pressure  <  50  mmHg  
 

  13  
Second  European  Consensus  Document        
1. Persistently  recurring  ischemic  rest  pain  requiring  analgesia  >  2  weeks        
and:  
Ankle  systolic  pressure  <  50  mmHg  
and/or  
Toe  systolic  pressure  <  30  mmHg  
 
2. Ulceration   or   gangrene   of   the   foot   or   toes                                                                                            
and:  
Ankle   systolic   pressure   <   50   mmHg                                                                                            
or:  
Toe  systolic  pressure  <  30  mmHg  
 
 
Modified  International  Vascular  Symposium  Working  Party  Definition        
1. Severe  rest  pain  requiring  opiate  analgesia  for  at  least  4  weeks          
and  either:  
2. Ankle  pressure  <  40  mmHg    
or:  
3. Tissue  necrosis  or  digital  gangrene                                                                        
 
 
 
 
 
 
RISK  FACTORS  OF  CHRONIC  CLI  
 
Chronic   CLI   is   the   end   result   of   peripheral  
atherosclerotic   arterial   occlusive   disease,   which   is  
associated   with   increasing   age,   hypertension,  
hypercholesterolemia,   cigarette   smoking,   diabetes,  
hyperhomocysteinemia,  inflammation  and  procoagulant  
markers   and   Blood   plasma   viscosity.   These   risk   factors,  
alone  and  in  combination,  contribute  to  the  prognosis  of  
PAOD  to  CLI.  
 
 
 

  14  
Age  
 
Age  is  risk  factor,  which  affects  the  limb  outcome.  Major  
amputations   are   more   common   in   the   elderly.   In   a  
population   with   a   mean   age   of   70   years,   each   year   of  
age   increases   the   risk   of   having   an   amputation   by   2%  
and   the   risk   of   not   recovering   from   CLI   by   about  
1%.(Bertele,  Roncaglioni  et  al.  1999)  
 
Smoking  
 
Cigarette   smoking   accelerates   the   atherosclerosis   and  
increases  the  progression  of  PAOD  to  CLI.  More  than  80  
%   of   patients   with   lower   extremity   PAD   are   current   or  
former   smokers.   (Smith,   Shipley   et   al.   1990;   Meijer,  
Hoes   et   al.   1998),   The   risks   associated   with   smoking  
apply   to   all   ages   and   increase   with   the   number   of  
cigarettes   smoked   per   day   and   the   number   of   years  
smoked.   (Cronenwett,   Warner   et   al.   1984),   The  
amputation   rates   are   very   high   among   the   smokers,  
when   compared   to   non-­‐smokers.   There   is   greater   graft  
failure   rate   in   subjects   who   smoke.   (Wiseman,   Powell   et  
al.   1990),   In   patients   with   CLI   who   have   undergone  
revascularization,  graft  patency  rates  are  improved  and  
smoking  cessation  reduces  amputation  rates.  
 
Diabetes  
 
Diabetes  is  a  particularly  important  risk  factor,  which  is  
often   associated   with   severe   PAD   and   neuropathy.   It   is  
the   most   common   cause   of   non-­‐traumatic   amputation,  

  15  
accounting   from   45%   to   75%.   Diabetes   accelerates   the  
atherosclerosis   in   the   blood   vessels;   especially   in   the  
arteries  of  lower  leg  and  it  is  proportional  to  the  severity  
and  the  duration  of  diabetes  (Beks,  Mackaay  et  al.  1995;  
Katsilambros,   Tsapogas   et   al.   1996).     Atherosclerosis   in  
distal   arteries   in   combination   with   neuropathy  
contributes   to   the   higher   rates   of   limb   loss   in   diabetic  
patients  and  the  risk  of  developing  CLI  is  also  greater  in  
diabetes   than   non-­‐diabetes   with   lower   extremity   PAD  
(Beckman,  Creager  et  al.  2002).  
 
Thus,   these   patients   have   a   10   fold   increased   rate   of  
amputation   compared   to   non-­‐diabetic   patients.   One  
study  reported  the  progression  of  CLI  to  gangrene  to  be  
40%   in   diabetic   patients   compared   with   9%   in   patients  
without  diabetes  (Kannel  1994).  
 
Hypertension  
 
Hypertension  is  associated  with  lower  extremity  PAD.  In  
the   Framingham   Heart   Study,   hypertension   increased  
the  risk  of  intermittent  claudication  2.5  to  4  fold  in  men  
and   women,   respectively   and   the   risk   was   proportional  
to  the  severity  of  high  blood  pressure  (Hirsch,  Haskal  et  
al.   2006)   but   there   is   no   current   evidence   to   prove   the  
involvement   of   hypertension   in   the   pathophysiology   of  
CLI.  On  the  other  hand  one  study  reported  that  decrease  
prevalence   of   hypertension,   over   a   period   of   9   years,  
were   associated   with   reduced   rates   of   lower   limb  
arterial   reconstruction   and   amputation   (Feinglass,  
Brown  et  al.  1999).  

  16  
  
Lipids  
 
Lipid   abnormalities   that   are   associated   with   lower  
extremity   PAD   include   elevated   total   and   low-­‐density  
lipoprotein   (LDL)   cholesterol,   decreased   high-­‐density  
(HDL)   lipoprotein   cholesterol   and   hypertriglyceridemia.  
There   is   some   evidence   that   LDL   predicts   the   presence  
of  PAD  (Drexel,  Steurer  et  al.  1996),  but  it  is  not  known  
whether   it   predicts   CLI.   Similarly,   it   is   unknown   that  
whether  lipid-­‐lowering  drug  therapy  prevents  CLI.  
 
Hyperhomocysteinaemia  
 
Hyperhomocysteinaemia   is   associated   with  
atherosclerosis  (Kuller  and  Evans  1998).  
 Evidences   show   that,   there   is   a   high   incidence   of  
hyperhomocysteinaemia   in   PAD   patients   with   rest   pain  
(Kuller  and  Evans  1998),  notably  in  younger  woman  (van  
den   Berg,   Stehouwer   et   al.   1996;   van   den   Bosch,  
Bloemenkamp   et   al.   2003).   Homocysteine   plays   an  
important   role   by   affecting   the   endothelium,   platelet  
function,  and  blood  clotting  but  the  homocystenie  levels  
do  not  predict  outcome  in  patients  with  CLI  who  under  
go   revascularization   procedures   (Laxdal,   Eide   et   al.  
2004).  
 
Inflammation  and  Procoagulant  markers  
 
Inflammation  and  endogenous  procoagulants  contribute  
the   micro   vascular   changes   in   CLI.   C-­‐reactive   protein  

  17  
(CRP),  a  marker  of  inflammation,  may  play  a  direct  role  
in   mediating   plaque   formation,   rupture   and   thrombosis.    
Raise  in  CRP  levels  also  predicts  the  endothelial  damage.  
Tissue   factor   is   a   pro   coagulant   marker,   which   is  
reported   to   elevated   in   patients  with   PAD   and   ischemic  
heart   disease.   Elevated   levels   of   tissue   factor   may   be  
related   to   endothelial   damage   and   detachment   (Yang  
and  Loscalzo  2000;  Makin,  Blann  et  al.  2004).  
 
 
Fibrinogen   is   an   important   component   in   the  
coagulation   cascade   and   platelet   aggregation,   and   also  
is   a   major   determinant   of   plasma   viscosity   (Woodburn,  
Rumley   et   al.   1995).   Increasing   levels   of   fibrinogen   are  
associated  with  a  fall  in  ABI  and  the  clinical  progression  
to  CLI  (Koksch,  Zeiger  et  al.  1999).  
 
 
Blood  Plasma  Viscosity  
 
Plasma   viscosity   is   increased   in   CLI   and   remains   raised  
even   after   revascularization.   Plasma   viscosity   is  
associated   with   worsening   symptoms   of   PAD   (Smith,  
Lowe  et  al.  1998),  and  may  progress  to  CLI  (Poredos  and  
Zizek   1996).   In   addition   with   the   changes   in   the   blood  
cells,   results   in   a   further   reduction   in   microcirculatory  
blood  flow.    
 
 
 
 

  18  
DIAGNOSING  TOOLS  OF  CLI    
 
Critical   limb   ischemia   should   be   suspected   for   all  
patients   presenting   with   chronic   ischemic   rest   pain,  
ulcers   or   gangrene   attributable   to   objectively   proven  
arterial   occlusive   disease   (Dormandy   and   Rutherford  
2000).     So   the   evaluation   of   patients   presenting   CLI  
should   be   started   from   a   detailed   history   talking   and  
thorough  clinical  examination.  
 
Most  of  these  patients  will  have  the  cardiovascular  risk  
factors   such   as   diabetes   with   or   without   renal  
complications,  hypertension,  elevated  cholesterol  levels,  
sleep   apnea   syndrome   may   be   they   will   have   a   past  
history  of  other  vascular  disease  such  as  MI  and  CVA.  
 
The  clinical  examinations  comprises  of  a  complete  head  
to   toe   examinations,   looking   for   arterial   murmurs,  
palpable   pulsatile   mass,   previous   surgical   scars,   ulcers  
and   gangrenes.   However   the   clinical   examinations   alone  
are   not   enough   and   it   should   be   proved   objectively   by  
the  following  methods.  
 
Laboratory  diagnosis:  
 
The  laboratory  diagnosis  includes    
 
1,  Ankle-­‐Brachial  Index  (ABI)  
2,  Ankle  systolic  pressure  
3,  Toe  pressure  and  Toe-­‐Brachial  Index  (TBI)  
4,  Capillaroscopy  

  19  
5,  Measurement  of  transcutaneous  Po2  
6,  Laser  fluxmetry  
 
Measurement  of  distal  limb  pressures:    
   
The   distal   limbs   pressures   comprises   of   none   other   than  
the  ankle  systolic  and  toe  pressures  
 
 
MEASUREMENT  OF  ANKLE  PRESSURE  
 
 

 
 
 
 
 
 

  20  
Ankle  systolic  pressure:  Its  is  measured  with  the  help  of  
a   continuous   wave   Doppler   probe   principally   over   the  
dorsalis   pedis   and   posterior   tibial   artery’s   in   case   of  
occlusion   of   both   artery’s   the   peronial   artery   will   be  
measured.   The   patients   suffering   from   CLI   will   have   a  
systolic  ankle  blood  pressure  below  50  mm  Hg.    
 
Unfortunately   the   measurement   of   ankle   systolic  
pressures   purely   depends   on   the   compressibility   of   the  
blood   vessels,   so   the   values   are   overestimated,   if   the  
vessels   are   calcified,   which   is   very   commonly   seen   in  
diabetes   and   chronic   kidney   disease   (Norgren,   Hiatt   et  
al.  2007).  
 
 
Ankle-­‐Brachial  Index:    
 
Ankle-­‐Brachial   Index   (ABI)   is   a   simple   and   inexpensive  
bedside  method  to  confirm  the  clinical  suspicion  of  the  
lower  extremity  arterial  occlusive  disease.  The  ABI  is  the  
ratio   between   the   highest   systolic   blood   pressure  
measured  at  the  ankle  and  the  highest  systolic  brachial  
pressure  using  a  continuous  wave  Doppler  probe.    
The  normal  values  lies  between  0.9  and  1.3.Usually  the  
patients  suffering  from  CLI  will  have  the  ABI  <  0.4.    Like  
the  systolic  ankle  blood  pressure  the  ABI  is  not  reliable  
in  the  presence  of  calcified  blood  vessels  (Norgren,  Hiatt  
et  al.  2007).  
 
 

  21  
Toe   Pressure:   This   measurement   is   very   useful   for  
patients   who   have   calcified   blood   vessels   because   toes  
are   usually   spared   from   medial   calcifications.     The   toe  
pressure   is   measured   by   placing   a   pneumatic   cuff   over  
the  greater  toe  and  a  photo-­‐electrode  is  placed  over  the  
end   of   the   toe   to   obtain   a   photoplethysmographic  
arterial  waveform  using  an  infrared  light,  the  other  toes  
can  be  used  in  case  of  amputation  of  greater  toe  is  seen.  
 
The   patients   having   a   toe   pressure   below   30   mm   Hg   are  
considered  as  CLI  patients  (Norgren,  Hiatt  et  al.  2007).  
 
 
Toe   Brachial-­‐Index:   TBI  is  nothing  but  the  ratio  between  
the   toe   pressure   and   the   highest   systolic   brachial  
pressure,  which  is  very  useful  in  patients  having  arterial  
calcifications   such   as   Diabetes,   elderly   patients   and  
chronic  renal  failure.  It  is  interpreted  as    

0.64 +/- .20 limbs normal

0.52 =/- .20 claudication in limbs

0.23 =/- .19 limbs with ulcers or ischemic rest pain

 
 
 
                               
 
 
 
 

  22  
  
 TOE  PRESSURE  MEASURING  DEVICE  
 

 
 
 
 

  23  
Capillaroscopy:   Capillaroscopy   may   be   useful   to   study  
the   microcirculatory   changes   of   the   ischemic   foot.  
Usually   the   greater   toe   is   preferred   for   the  
capillaroscopic   examination,   which   allows   investigating  
the   capillary   morphology   and   density.   A   sophisticated  
and   computerized   technique   of   capillaroscopy   (video  
photometric   capillaroscopy)   also   permits   to   study   non-­‐
invasively   the   blood   flow   in   the   nutritional   skin  
capillaries.     Normally   the   Fagrell   stages   are   use   for  
reporting  (Fagrell  1973;  Schwartz,  Freedman  et  al.  1984)  
 
Stage   A:   Capillaries   are   well   seen   and   filled   with  
erythrocytes,  
 
Stage   B:   Presence   of   interstitial   edema,   capillaries   are  
not   well   differentiated   and   he   presence   of   capillary  
hemorrhages;      
 
Stage   C:   Almost   few   or   non   perfused   capillaries   are  
visualized;  
 
If   the   capillaries   are   well   perfused   and   filled   with   red  
blood  cells,  the  risk  of  skin  necrosis  will  be  less  than  10  
%  in  three  months,  independent  of  the  microcirculatory  
status.  
 
However   this   method   is   not   feasible   for   the   day-­‐to-­‐day  
use   due   to   lot   of   practical   difficulties,   but   it   can   be  
considered  for  the  research  purposes.  
 

  24  
Measurement   of   transcutaneous   Po2:   Transcutaneous  
measurement   of   oxygen   tension   (TcPo2)   provides   non-­‐
invasive   and   continuous   information   on   skin   oxygen  
using   the   basic   electrodes   of   conventional   blood   gas  
machines   (Franzeck,   Talke   et   al.   1982).   The   skin   is  
heated   to   enable   the   surface   sensors   to   respond   quickly  
to  the  gas  tension  under  them.  PtcO2  is  variable,  which  
reflects   the   PO   2   in   the   peripheral   tissue.   In   patients  
without   decreased   cardiac   out   put,   TcPo2   follows   the  
trend   of   the   arterial   gas   tension,   and   the   TcPo2   value  
decreases   proportionally   to   Pa02.   When   peripheral  
perfusion   is   severely   reduced,   TcPo2   looses   its  
relationship   with   the   arterial   tensions   and   becomes  
blood   flow   dependent,   thus   providing   quantitative  
evaluating  of  blood  flow.  
   
The  TcPo2  of  the  ischemic  area  in  CLI  will  be  equal  to  10  
mmHg   or   less   if   the   legs   are   placed   in   supine   position  
without   any   improvement   in   the   measurement   even  
after   the   inhalation   of   oxygen   or   placing   the   legs   in  
dependent  position.  The  TcPo2  value  more  than  20  mm  
Hg   in   supine   position   or   improvement   in   the   TcPo2  
reading  after  the  inhalation  of  oxygen  or  placing  the  legs  
in   dependent   position   is   a   sign   of   good   prognosis  
(Bongard  and  Krahenbuhl  1988;  1992).  
 
The  measurement  of  TcPo2  is  a  more  accurate  predictor  
of   future   limb   amputation   in   patients   with   non-­‐
reconstructible  CLI.  
 
 

  25  
  
 
                                           TcPO2  MEASURING  DEVICE  
 

 
 

  26  
Laser   Doppler   fluxmetry:   Laser   Doppler   fluxmetry  
allows  continuous,  non-­‐invasive,  real  time  assessment  of  
skin   perfusion   (Nilsson,   Tenland   et   al.   1980;   Schabauer  
and  Rooke  1994).  Using  LD  fluxmetry,  leg  skin  perfusion  
can   be   assessed   in   baseline   conditions   and   in   response  
to   different   stimuli,   such   as   ischemia   and  
pharmacological  substances.  In  particular,  leg  skin  post-­‐
ischemic   hyperemia   is   a   widely   used   test   to   study  
vasoregulatory   adaptation   in   patients   with   POAD   and  
CLI  (Rossi  and  Carpi  2004).      
 
 
Values   of   skin   perfusion   below   normal   values   have   been  
recorded  only  at  the  level  of  toe  pulp  in  PAOD  patients  
with  CLI.  A  severely  altered  pattern  of  skin  flow  motion,  
with   reduced   prevalence   of   slow   waves   and   increased  
prevalence  of  fast  waves,  has  been  recorded  in  patients  
with  CLI  at  the  diseased  legs  (Rossi  and  Carpi  2004).  
 
With  regard  to  normal  subjects,  patients  with  CLI  show  
an   increased   skin   LD   flux   during   leg   dependency.   This  
suggests   that   the   normal   postural   vasoconstriction  
response,  that  limits  the  increase  of  capillary  pressure,  is  
compromised   in   patients   with   CLI   (Eickhoff   1980;  
Ubbink,  Jacobs  et  al.  1991).  
 
The   LD   fluxmetry   readings   in   combination   with   TcPo2  
measurement   can   be   used   for   predicting   the   risk   of  
amputation   in   non-­‐reconstructible   CLI   patients   (Rossi  
and  Carpi  2004).  
 

  27  
Radiological   Diagnosis:   Clinical   examination   and   the  
laboratory   test   might   give   un   idea   about   the  
physiological   and   hemodynamic   assessment,   but   it  
should  always  be  proved  by  radiological  methods,  which  
helps   to   assess   the   anatomic   lesions   and   also   it   plays   a  
vital   role   to   determine   therapeutic   options   between  
endovascular  or  surgical  reconstruction  (1992;  Norgren,  
Hiatt  et  al.  2007).    
 
 
The   radiological   diagnosis   may   be   obtained   by   the  
following  methods  
 
1,  Intra-­‐arterial  angiography  
2,  Vascular  ultrasound  or  Duplex  ultrasonography    
3,Computed  tomographic  angiography  (angio  CT)  
4,Magnetic  resonance  angiography  (MRA)  
 
Intra-­‐arterial  angiography:  Angiography  is  considered  as  
the   gold   standard   for   defining   both   normal   vascular  
anatomy   and   vascular   pathology.   The   basis   of   modern  
angiography   is   the   seldinger   technique,   the  
percutaneous  introduction  of  a  plastic  catheter  in  to  an  
artery.   Normally   iodinated   contrast   agents   are   used   to  
visualize   the   arteries   but   we   can   use   non   iodinated  
contrast  agents  such  as      CO  2  is  also  used  for  peripheral  
arteriography   in   patients   with   contraindications   to  
iodinated  contrast  (Back,  Caridi  et  al.  1998).  
 
Although   angiography   remain   the   gold   standard  
significant   advances   in   duplex,   magnetic   resonance,  

  28  
computed   tomographic   imaging   techniques   may   make  
these   newer   modalities   preferable   to   angiography   in  
certain  conditions.  In  addition  non-­‐invasive  imaging  such  
as   duplex,   MRA   or   CTA   may   allow   better   preparation  
before  initiating  an  invasive  procedure  (Hirsch,  Haskal  et  
al.  2006).  
 
Currently,   the   contrast   angiography   remains   the  
dominant  diagnostic  tool  used  to  stratify  patients  before  
intervention  (Hirsch,  Haskal  et  al.  2006).  
 
The   complications   of   conventional   angiography   are  
related   primarily   to   the   arterial   puncture   and   the  
contrast  agents.    
 
The   complications   are   listed   on   the   below   table   (1993;  
AbuRahma,  Robinson  et  al.  1993)  
 
Complications                Acceptable  incidence  
                                                   
Hematoma  (requiring  transfusion,  surgery  or                                                  <  3%  
delayed  discharge)    
   
Access  artery  occlusion                                                  <  0.5%  
   
Pseudo  aneurysm                                                  <  0.5%  
   
Arteriovenous  fistula                                                  <  0.1%  
   
Distal  emboli                                                  <  0.5%  
   
   
Arterial  dissection/sub                                                    <  2.0%  
intimal  passage    
   
Sub  intimal  injection  of  contrast                                                    <  1.0%  
   
 
 

  29  
  
Vascular   ultrasound   or   Duplex   ultrasonography:    
Duplex   ultrasonography   is   a   non-­‐invasive   technique  
used   primarily   for   the   evaluation   of   the   arteries   of   the  
lower   extremities.   It   also   has   broad   clinical   utility   for  
evaluation   of   aneurysms,   arterial   dissections,   popliteal  
artery   entrapment   syndrome,   and   assessment   of   soft  
tissue   masses   in   individuals   with   vascular   disease.    
Because   of   the   non-­‐invasive   technique   and   broad  
clinical   utility,   thus   it’s   recommended   as   a   first   line  
screening  technique  (Hirsch,  Haskal  et  al.  2006).  
 
The  primary  clinically  relevant  information  derived  from  
duplex  studies  has  been  validated  from  analysis  of  blood  
flow.  Quantitative  criteria  used  to  diagnose  stenosis  are  
based  on  peak  systolic  velocity  and  peak  systolic  velocity  
ratios  within  or  beyond  the  stenosis  compared  with  the  
adjacent  upstream  segment,  the  presence  or  absence  of  
turbulence,   and   preservation   of   pulsatility.   The   main  
disadvantages  are  it  is  operator-­‐dependency,  the  limited  
field   of   view   and   the   limited   imaging   in   patients   with  
severe   calcification   such   as   in   diabetics.   Therefore,   this  
method  has  limitations  especially  in  patients  with  CLI.  
 
Computed   Tomographic   Angiography:   CTA   has   been  
widely   used   to   visualize   the   arteries   of   the   lower   limbs  
and   to   diagnose   the   anatomic   location   and   the   degree  
of   stenosis   in   patients   suffering   from   CLI,   with   recent  
advancement   in   CTA,   which   permits   to   scan   the   aorta  
and  the  lower  limb  arteries  within  a  minute.  
 

  30  
CTA   also   has   some   disadvantages   such   as   irradiations,  
use   of   iodinated   contrast   products,   limited   view   in   the  
presence   of   arterial   calcification,   the   presence   of   stent  
make  difficult  to  assess  the  intra-­‐arterial  stenosis.    
 
In  general  CTA  is  useful  for  visualizing  the  overall  view  of  
the   arterial   structures   of   the   lower   limb   in   a   three  
dimensional  view,  but  the  below  knee  and  pedal  arteries  
are   poorly   visualized,   with   is   frequently   encountered  
problem  in  patients  suffering  from  CLI.  
 
Magnetic   Resonance   Angiography:   Many   vascular  
centers   prefer   MRA   for   the   arterial   evaluation   of  
patients  suffering  from  CLI.    Like  CTA,  MRA  also  produce  
images   of   vascular   structures   in   cross-­‐sectional   slices  
that   can   be   reformatted   into   three-­‐dimensional  
angiographic   images.   In   a   randomized   trial   comparing  
MRA   and   CTA   for   initial   imaging   in   PAD,   the   two  
techniques   were   similar   in   ease   of   use   and   clinical  
outcome   (Ouwendijk,   de   Vries   et   al.   2005).   It   mainly  
depends   on   the   local   availability   and   expertise   which  
method  is  preferentially  used.  
 
The   advantages   of   MRA   are   good   imaging   of   arteries  
even   in   the   presence   of   calcifications,   absence   of  
ionizing   radiation   and   iodinated   contrast   products.  
Therefore   until   recently   MRA   was   primarily  
recommended  in  patients  with  impaired  renal  function.  
However,   recent   reports   shows   that   the   exposure   to  
gadolinium-­‐containing   contrast   agents   during   MRA   in  
patients  with  advanced  renal  disease  (GFR<  30  mL/min)  

  31  
may   cause   a   severe   skin   disease   called   nephrogenic  
fibrosing  dermopathy  (NFD)  characterized  by  thickening  
and   hardening   of   the   skin,   mostly   in   extremities  
(Sadowski,   Bennett   et   al.   2007).   These   skin   lesions   can  
progress   rapidly,   sometimes   leading   to   joint   immobility  
and  the  inability  to  walk.  
The   major   disadvantages   include   overestimation   of  
arterial   stenosis   in   iliac   and   femora-­‐popliteal   arteries  
and   the   MRA   is   contraindicated   in   patients   have   pace  
makers  and  metallic  prosthesis.  
 
7,  ORIGINAL  STUDY  
 
A,  Study  questions  
 
 The   purpose   of   this   study   is   to   analyze   the   one-­‐year  
outcome   of   diabetic   patients   with   trophic   lower  
extremity   lesions   and   critical   limb   ischemia   with   or  
without  trophic  lesions  
 
B,   Methods:   All   files   coded   as   “diabetes   and   trophic  
lower   extremity   lesion”   or   “critical   limb   ischemia”   was  
retrieved  from  the  database  of  the  Unit  of  angiology  for    
the  period  from  Jan  2009       to  Dec  2009.  The  documents  
were  made  anonymous  and  the  one-­‐year  outcome  was  
ascertained   from   the   patient   chart   or   by   phone   call   with  
the  practitioner  in  charge.  
 
C,   Results:   There   were   132   patients   corresponding   to  
the  selection  criteria  were  retrieved.  In  6  cases,  the  one-­‐
year   outcome   could   not   be   ascertained.   The   patient  

  32  
population   consists   of   126   patients   (46  females   and   80  
males)  with  a  median  age  of      76.50     (extremes  from  39  
to   99).   From   the   selected   126   patients,   2   patients   are  
diabetic   with   trophic   lesion   and   no   critical   limb   ischemia  
associated   on   both   lower   limbs,   1   patient   had   diabetes  
with  trophic  lesions  on  both  legs,  associated  with  critical  
limb   ischemia   on   one   lower   extremity   (left   leg)   and   1  
patient   was   non   diabetic   with   trophic   lesions   on   both  
the  legs  including  critical  limb  ischemia.  As  a  result,  130  
limbs  were  obtained  for  the  study.    
 
In  the  overall  population  of  126  patients,  87.3%  patients  
were  having  arterial  hypertension,  73.8%  patients  were  
diabetic,   58.7%   patients   were   treated   for   dyslipidemia  
and   57.9%   patients   were   smokers   and   49.2%   patients  
were  positive  for  critical  limb  ischemia.  
 
The  table  no.1  describes  the  distribution  of  frequencies  
such  as  gender,  number  of  patients  positive  for  CLI  and  
cardiovascular   risk   factors   like   diabetes,   hypertension,  
dyslipidemia   and   smoking   in   the   overall   population   of  
126  patients.    
 
These   126   patients   (130   limbs)   were   divided   into   3  
groups  as  following  
 
1,  Patients  who  have  critical  limb  ischemia  and  diabetes  
(CLI  +  DM  +)    
 
2,   Patient   who   have   critical   limb   ischemia   without  
diabetes  (CLI  +  DM  -­‐).  

  33  
  
3,   Patients   who   have   no   critical   limb   ischemia   and  
having  diabetes  (CLI  –  DM  +).  
 
The   above-­‐described   groups   were   divided   into   patients  
and  limbs  and  their  population  distribution  were  shown  
through  table  2  &  3  
 
Table  no.1  
   
   
Variables   Total  number  of  patient  (n)  =  126  

   
   
Male  population                                          80  (63.5%)  

   
   
Female  population                                          46  (36.5%)  

   
   
Smokers                                          73  (57.9%)  

   
   
Diabetes                                          93  (73.8%)  

   
   
Hypertension                                          110  (87.3%)  

   
   
Dyslipidaemia                                          74  (58.7%)  

   
   
CLI  positive  patients                                          62  (49.2%)  

  34  
Table  no.2  
 
   
   
                                           Groups                                      Number  of  Patients  

                                                         
   
Patients  positive  for  both  diabetes  et                                                                29(  23%)  
critical  limb  ischemia    (CLI  +  DM  +)  
   
   
Patients  positive  for  critical  limb  ischemia                                                                33  (26%)  
and  no  diabetes  (CLI  +  DM  -­‐)  
     
   
Patients  positive  for  only  diabetes  et  no                                                              64  (51%)  
critical  limb  ischemia  (CLI  –  DM  +)  

   
   
Total  number  of  patients                                                                      126  

 
 
Table  no.3  
 
   
   
                                           Groups                                      Number  of  limbs    

                                                         
   
Patients  positive  for  both  diabetes  et                                                                29  (22%)  
critical  limb  ischemia    (CLI  +  DM  +)  
   
   
Patients  positive  for  critical  limb  ischemia                                                                34  (26%)  
and  no  diabetes  (CLI  +  DM  -­‐)  
     
   
Patients  positive  for  only  diabetes  et  no                                                              67  (52%)  
critical  limb  ischemia  (CLI  –  DM  +)  
   
   
Total  number  of  limbs                                                                            130  

  35  
Clinical  outcome    
 
During  the  one-­‐year  study  period,  40  patients  (41  lower  
limbs)   were   benefited   arterial   revascularization,   39  
patients   were   under   gone   amputation.   Among   these  
patients,   major   amputations   (above   the   ankle   joint)  
were  performed  in  25  patients  and  41  patients  (32%  of  
the  total  population)  were  deceased.  Their  details  were  
well  described  by  the  tables  4  &  5.  
 
Revascularization    
 
Almost   40   patients   (41   lower   limbs)   were   benefited  
revascularization,   which   constitutes   about   31   %   of   the  
total   study   population.   The   occurrence   of  
revascularization   between   CLI   +   DM-­‐   was   18   (54%)   per  
33  patients,  then  comes  CLI+  DM  +  which  hold  12  (41%)  
per  29  patients  and  followed  by  CLI-­‐  DM+  which  posses  
10   (16%)   per   64   patients.   The   technique   utilized   for  
revascularization   were   either   surgical   or   endovascular,  
certain   among   them   had   both   surgical   and  
endovascular.  (Table  no.4)  
 
As   described   earlier,   41   lower   limbs   (32%)   were  
benefited   revascularization.   Only   the   group   CLI   –   DM   +  
had   one   lower   limb   in   addition   to   be   revascularized,  
which   makes   a   total   of   11   (16%)   per   67   lower   limbs.  
(Table  no.5)  
   
 
 

  36  
Amputation  
 
Approximately  39  (39  lower  limbs)  patients  were  under  
gone  amputation  over  a  period  of  12  months.  Between  
these   patients   14   patients   had   minor   amputation  
(amputation   which   limits   at   the   level   of   metatarsal  
bones)   and   25   patients   had   major   amputation   (above  
the  ankle  joint).  
 
The   group   CLI   –   DM   +   had   undergone   the   majority   of  
minor   amputation   i.e.   12   (19%)   per   64   patients,   where  
as   none   of   them   undergone   minor   amputation   in   the  
group  CLI  +  DM  -­‐.  
 
The  groups  CLI  +  DM  +,  CLI  +  DM  -­‐  had  equal  number  of  
patients  undergone  major  amputation  i.e.  9(31%  &  27%)  
per  29  and  33  patients  respectively.    Where  as  the  group  
CLI  –  DM  +  has  7  (11%)  per  64  patients.  (Tables  4  &  5)  
 
Mortality  
 
Nearly  15  patients  (12%)  were  died  at  3  months  and  an  
overall   of   41   patients   were   died   at   12   months.   The  
mortality   (both   at   3   &   12   months)   was   high   in   the   group  
CLI  +  DM  -­‐.  (Table.no  4)  
 
 
 
 
 

  37  
 Table  no.4
                 
                                                     REVASCULARISATION                                                                                                AMPUTATION                              DEATH  
             
       GROUPS        PATIENTS                                                  THREE  MONTHS                            TWELVE  MONTHS   THREE   TWELEVE  
       ANY   SURGICAL   ENVOVASCULAR    BOTH   MONTHS   MONTHS  
ANY   MINOR   MAJOR   ANY   MINOR   MAJOR  

                                               
                           
                           
CLI  +  DM  -­‐        29(23%)   12(41%)      5(17%)                  8(27%)      1(3%)      7(24%)        2(7%)   5(17%)   11(38%)   2  (7%)   9(31%)      5(17%)    11(38%)  

                                     
                           
                           
CLI  +  DM  -­‐        33(26%)    18(54%)   13(39%)                    8(24%)      3(9%)      5(15%)                  0   5(15%)   9(27%)                0   9(27%)        9(27%)    14  (42%)  

                                   
                           
                           
CLI  –  DM  +        64(51%)    10(16%)        5(8%)                      5(8%)                0   17(26%)   10(16%)   7(11%)   19(30%)   12(19%)   7(11%)          1(1%)      16  (24%)  

                             
             
             
TOTAL        126    40(31%)   29(23%)   39(31%)   15(12%)   41(32%)  

  38  
  
Table  no.5
               
                                                     REVASCULARISATION                                                                                                AMPUTATION  
             
       GROUPS                LIMBS                   THREE  MONTHS   TWELVE  MONTHS  
       ANY   SURGICAL   ENVOVASCULAR    BOTH  
ANY   MINOR   MAJOR   ANY   MINOR   MAJOR  

                                           
                       
                       
CLI  +  DM  -­‐        29(22%)   12(41%)      5(17%)                  8(27%)      1(3%)      7(24%)        2(7%)   5(17%)   11(38%)   2  (7%)   9(31%)  

                                 
                       
                       
CLI  +  DM  -­‐        34(26%)    18(53%)   13(38%)                    8(24%)      3(9%)      5(15%)                  0   5(15%)   9(26%)                0   9(26%)  

                       
                       
                       
CLI  –  DM  +        64(52%)    10(16%)        5(7%)                      6(9%)                0   17(25%)   10(15%)   7(10%)   19(28%)   12(18%)   7(10%)  

                         
         
         
TOTAL        130    41(31%)   29(22%)   39(30%)  

  39  
D,  Discussions  
 
This   study   shows   the   one-­‐year   out   come   of   diabetic  
patients  with  trophic  lesion  on  the  lower  limb  and  chronic  
limb   ischemia   with   or   with   out   trophic   lesions.   The  
outcomes   rely   upon   amputation   rate   and   mortality   rate  
during  the  study  period.    
 
Among  these  126  patients  almost  62  patients  (49%)  were  
known  for  critical  limb  ischemia.  The  CLI  positive  group  (62  
patients),   almost   30   patients   (48%)   benefited  
revascularization.   The   overall   amputation   rates   were   also  
high   in   this   group,   which   has   a   population   of   20   patients  
(32%),   among   them   18   patients   (29%)   had   undergone  
major  amputation  at  12  months.    
 
On   the   other   hand   the   CLI   negative   group   consists   of   64  
patients  (51%),  all  of  them  are  diabetic  with  trophic  lesions  
in   the   lower   extremity.     In   this   group,   only   10   patients  
(16%)   were   benefited   revascularization,   but   the   overall  
amputation  rates  were  almost  equal  to  CLI  positive  group  
i.e.  19  patients  (30%)  were  amputated,  however  I  this  the  
minor   amputation   contributes   more   when   compared   to  
major  amputation  i.e.  12  patients  (19%)  were  amputated      
at   the   level   of   toes.   This   signifies   most   of   the   diabetic  
patients   had   minor   amputation   and   most   of   the   CLI   had  
major  amputation  at  12  months.  
 
The   mortality   rate   also   tremendous   in   CLI   positive   group,  
between  these  62  patients  25  patients  (40%)  were  dead  at  
12   months,   while   the   CLI   negative   group   had   only   16  
patients  (24%)  at  12  months.  (Table  no.6)  
 
 
 
 
 
 
 

  40  
 Table  no.  
                 
                                                     REVASCULARISATION                                                                                                AMPUTATION                              DEATH  
             
       GROUPS        PATIENTS  
                THREE  MONTHS   TWELVE  MONTHS   THREE   TWELEVE  
       ANY   SURGICAL   ENVOVASCULAR    BOTH   MONTHS   MONTHS  
ANY   MINOR   MAJOR   ANY   MINOR   MAJOR  

                                               
                           
                           
CLI  POSITIVE        62(49%)   30(48%)      18(29%)                  16(25%)      4(6%)   12(19%)        2(3%)   10(16%)   20(32%)   2  (3%)   18(29%)      14(22%)    25(40%)  

                                   
                           
                           
CLI  NEGATIVE        64(51%)    10(16%)        5(8%)                      5(8%)                0   17(26%)   10(16%)   7(11%)   19(30%)   12(19%)   7(11%)          1(1%)      16  (24%)  

                             
             
             
TOTAL        126    40(32%)   29(23%)   39(31%)   15(12%)   41(32%)  

  41  
The  overall  amputation  at  3  &  12  months  were  described  
by  the  following  bar  graph  
 
 
 

 
 
 
 
 
In   the   overall   study   population   111   patients   (88%)   were  
alive   and   15   patients   (12%)   died,   among   the   live   patients  
87   patients   (79%)   were   alive   without   any   amputation,  
however   13   patients   (12%)   were   alive   with   major  
amputation.   But   in   course   of   time   i.e.   at   12   months   the  
mortality   was   increased   to   41   patients   (32%).   Only   85  
patients   (67%)   were   alive,   between   them   51   patients  
(60%)   were   alive   with   out   amputation,   but   almost   20  
patients   (23%)   were   alive   with   major   amputation.   This  
demonstrates  in   course   of   time   there   is   a   significant   risk   in  
mortality   as   well   as   amputation   rates   in   particular   major  
amputation.  
 
E,  Conclusions  
 
In   conclusion,   the   end   results   of   this   study   have   some  
suggestions.  The  total  amputation  rate  were  almost  similar  
in   both   CLI   positive   and   negative   group,   however   the   CLI  
positive   groups   has   more   number   of   major   amputation,  

  42  
whereas   the   minor   amputation   rates   were   high   in   CLI  
negative   group.   Therefore   a   holistic   approach   by  
healthcare   professionals   who   are   familiar   with   the  
treatment   of   complicated   diabetic   patients   (lower   limb  
trophic  lesions)  and  critical  limb  ischemia  is  indispensable  
in   order   to   identify   the   high-­‐risk   patients   and   start  
appropriate   treatment.   We   found   that   all   patients   with  
trophic   lesions   don’t   fall   in   the   category   of   critical   limb  
ischemia,   so   the   definition   of   the   CLI   should   be   well  
respected.   We   found   that   patients   with   and   without   CLI  
differ  in  clinical  characteristics  and  outcome.    The  patients  
with   proven   PAD   should   have   a   regular   check   up   by  
vascular   specialist   and   should   be   treated   at   appropriate  
time  to  avoid  the  further  complications.  
 
Taking  into  account  of  the  overall  amputation  outcome  in  
the  CLI  negative  group,  were  all  are  diabetic,  which  has  a  
predominant   minor   amputation   rates,   proves   that   early  
detection   and   good   medical   management   such   as  
treatment   of   ulcers   and   infection   control   are   urgently  
needed.  
 
8,  SUMMARY  AND  GENERAL  CONCLUSION  
 
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