ueda2012 predictors of diabetic foot ulcer-d.walaa

1. Predictors of the outcome ofPredictors of the outcome of
diabetic foot ulcer at Assiutdiabetic foot ulcer at Assiut
university hospitaluniversity hospital
ByBy
Walaa Anwar Muhammad KhalifaWalaa Anwar Muhammad Khalifa
M.B.B.CHM.B.B.CH
M.ScM.ScFaculty of medicineFaculty of medicine
Assiut UniversityAssiut University
Under supervision ofUnder supervision of
Prof. Dr. Lobna Farag EltoonyProf. Dr. Lobna Farag Eltoony
Professor of internal medicine&head of endocrinology unitProfessor of internal medicine&head of endocrinology unit
Faculty of medicineFaculty of medicine
Assiut UniversityAssiut University
Dr. Mona Muhammad SolimanDr. Mona Muhammad Soliman
LecturerLecturer of internal medicineof internal medicine
Faculty of medicineFaculty of medicine
Assiut UniversityAssiut University

2. IntroductionIntroduction
 Diabetic foot ulcers are a common and muchDiabetic foot ulcers are a common and much
feared complication of diabetes, with recentfeared complication of diabetes, with recent
studies suggesting that the lifetime risk ofstudies suggesting that the lifetime risk of
developing foot ulcer in diabetic patients may bedeveloping foot ulcer in diabetic patients may be
as high as 25% (Singh et al.,2005).as high as 25% (Singh et al.,2005).
 Up to 50% of older patients with type 2 diabetesUp to 50% of older patients with type 2 diabetes
have one or more risk factors for foot ulceration.have one or more risk factors for foot ulceration.
 A list of the principal risk factors that mightA list of the principal risk factors that might
result in foot ulcer development areresult in foot ulcer development are
demonstrated ( Abbott et al ., 2002.)demonstrated ( Abbott et al ., 2002.)

3. Risk factors of foot ulcerRisk factors of foot ulcer
1-1- Previous amputation.Previous amputation.
2-2- Past history of foot ulceration.Past history of foot ulceration.
3-3- Peripheral neuropathy.Peripheral neuropathy.
4-4- Peripheral vascular disease.Peripheral vascular disease.
5-5- Foot deformityFoot deformity..
6-6- Visual impairment.Visual impairment.
7-7- Diabetic nephropathy.Diabetic nephropathy.
8-8- Poor glycemic controlPoor glycemic control..
9-9- Cigarette smokingCigarette smoking

5.  The most common triad of causes thatThe most common triad of causes that
interact and result in foot ulceration hasinteract and result in foot ulceration has
been identified asbeen identified as neuropathyneuropathy,, deformitydeformity
andand traumatrauma ( Boulton et al., 2004)( Boulton et al., 2004)

6. • The risk of amputation is 15 to 40 timesThe risk of amputation is 15 to 40 times
greater in a person with diabetes than ingreater in a person with diabetes than in
one who doesn't have the diseaseone who doesn't have the disease
( Nabuurs et al..2005).( Nabuurs et al..2005).

7.  The population of diabetic patients whoThe population of diabetic patients who
present with foot ulceration arepresent with foot ulceration are
heterogenous,there are characteristics thatheterogenous,there are characteristics that
may vary among patients, such as themay vary among patients, such as the
presence of peripheral arterial diseasepresence of peripheral arterial disease
infection,andco-morbidities.infection,andco-morbidities.
Peripheral arterial disease is consideredPeripheral arterial disease is considered
an important predictor of outcomean important predictor of outcome
(Prompers et al., 2007).(Prompers et al., 2007).

8.  Therefore. Outcome data on these patientsTherefore. Outcome data on these patients
with diabetic foot ulcer are needed such awith diabetic foot ulcer are needed such a
requirement is underlined by the fact thatrequirement is underlined by the fact that
although diabetic foot ulcers are usuallyalthough diabetic foot ulcers are usually
reported and analyzed as one clinicalreported and analyzed as one clinical
entity marked differences in patient, footentity marked differences in patient, foot
and ulcer characteristics can exist betweenand ulcer characteristics can exist between
patientspatients.. These observations raise theThese observations raise the
question of wether predictors of outcome inquestion of wether predictors of outcome in
patients may differ (Prompers et al., 2007).patients may differ (Prompers et al., 2007).

9. The aim of the studyThe aim of the study
 To assess the potential baseline clinical andTo assess the potential baseline clinical and
laboratory characteristics that best predict poorlaboratory characteristics that best predict poor
outcome (non healing of the foot ulcer).outcome (non healing of the foot ulcer).
 The main outcome of the study is completeThe main outcome of the study is complete
healing of the foot within the maximum followhealing of the foot within the maximum follow
up period of 1 year.up period of 1 year.
 Healing was defined as healing (intact skin) ofHealing was defined as healing (intact skin) of
the whole foot at two consecutive visits.the whole foot at two consecutive visits.

10. Patients & study designPatients & study design
 It is a prospective study in which 100It is a prospective study in which 100
patients with diabetic foot ulcer will bepatients with diabetic foot ulcer will be
followed and managed for 1 year.followed and managed for 1 year.
 About 50 patients are still underAbout 50 patients are still under
research.research.
 Patients includedPatients included were those presentingwere those presenting
for the first time with a new foot ulcerfor the first time with a new foot ulcer
within period of 12 months.within period of 12 months.

11. Excluded patientsExcluded patients
1- Patients who had been treated for an1- Patients who had been treated for an
ulcer on the ipsilateral foot during theulcer on the ipsilateral foot during the
previous 12 months.previous 12 months.
2- Patients with sever end organ2- Patients with sever end organ
failure.failure.
3- Patients with gangrenous foot. eg,3- Patients with gangrenous foot. eg,
gas gangrene.gas gangrene.

12. MethodMethod
 Data collected prospectively of patientsData collected prospectively of patients
referred to a foot care clinicreferred to a foot care clinic
recordedrecorded
Data include.Data include.
 Demographics,detailed history and completeDemographics,detailed history and complete
physical examinationphysical examination
 Data on co- morbidities including ( retinopathyData on co- morbidities including ( retinopathy
nephropathy, hypertension and ischemic heartnephropathy, hypertension and ischemic heart
disease) .disease) .

13.  Data on foot examinationData on foot examination
include.include.
(foot inspection, Pedal(foot inspection, Pedal
pulse, ABI measurementpulse, ABI measurement
and joint examination).and joint examination).
 Data on ulcerData on ulcer
characteristics.characteristics.
ulcers were classifiedulcers were classified
according toaccording to
1-PEDIS system.1-PEDIS system.
( perfusion, extent, depth,( perfusion, extent, depth,
infection and sensation )infection and sensation ) ..

14. 22--Meggitt- wagner classification of
foot ulcers
Grade0Grade0:Pre- or post- ulcerative lesion:Pre- or post- ulcerative lesion
completely epithelializedcompletely epithelialized
Grade1Grade1:Superficial, full thickness:Superficial, full thickness ulcer limitedulcer limited
to the dermis, not extending to the subcutisto the dermis, not extending to the subcutis
Grade 2Grade 2:Ulcer of the skin extending through the:Ulcer of the skin extending through the
subcutis with exposed tendon or bone andsubcutis with exposed tendon or bone and
without osteomyelitis or abscesswithout osteomyelitis or abscess
Grade 3Grade 3:Deep ulcers with osteomyelitis or:Deep ulcers with osteomyelitis or
abscess formationabscess formation
GradeGrade 44:Localized gangrene of the toes or the:Localized gangrene of the toes or the
forefootforefoot
GradeGrade 55:Foot with extensive gangrene:Foot with extensive gangrene

15. 3- The university of Texas classification 1998
StageStage
GradeGrade
00 11 22 33
AA Pre- or post-Pre- or post-
ulcerativeulcerative
lesionlesion
completelycompletely
epithelailizdepithelailizd
SuperficialSuperficial
wound notwound not
involvinginvolving
tendon,tendon,
capsule orcapsule or
bonebone
WoundWound
penetratingpenetrating
to tendon orto tendon or
capsulecapsule
WoundWound
penetratingpenetrating
to bone orto bone or
jointjoint
BB WithWith
infectioninfection
WithWith
infectioninfection
WithWith
infectioninfection
WithWith
infectioninfection
CC WithWith
ischemiaischemia
WithWith
ischemiaischemia
WithWith
ischemiaischemia
WithWith
ischemiaischemia
DD WithWith
infectioninfection
and ischemiaand ischemia
WithWith
infectioninfection
andand
ischemiaischemia
WithWith
infectioninfection
and ischemiaand ischemia
WithWith
infectioninfection
and ischemiaand ischemia

16.  Laboratory data includeLaboratory data include
Complete blood picture, liverComplete blood picture, liver
function, urea and creatinine ,24function, urea and creatinine ,24
hrs proteins in urine, creatininehrs proteins in urine, creatinine
clearance, lipogram and (Hb A1c)clearance, lipogram and (Hb A1c)
..

17. Management of diabetic foot ulcerManagement of diabetic foot ulcer
All Patients were treated According to protocols basedAll Patients were treated According to protocols based
on the international consensus on the diabetic footon the international consensus on the diabetic foot
which include offloading ,diagnosis and treatment ofwhich include offloading ,diagnosis and treatment of
infection, assessment of vascular status and regularinfection, assessment of vascular status and regular
wound debridement .wound debridement .

18. Results of 50 patients:
In 50 patients: 34 (68%) females ,
the mean age 50.76 ± 13.35.

19. Diagram (2) :shows results of patient
characteristics
non-sm
okers
pasthistory
ofam
putation
insulin
therapy
neuropathic
sym
ptom
s
0
10
20
30
40
50
no.ofcases

20. Diagram(3):shows results ofDiagram(3):shows results of
foot inspectionfoot inspection

21. VariableVariable
HealedHealed
(n= 31)(n= 31)
UnhealedUnhealed
(n= 19)(n= 19)
TotalTotal
(n= 50)(n= 50) P-valueP-value
Age: 47.39 ± 11.4247.39 ± 11.42 56.26 ± 16.7656.26 ± 16.76 50.76 ± 13.3550.76 ± 13.35 0.0210.021
Sex:
0.0140.014Males n% 6(37.5%)6(37.5%) 10(62.5%)10(62.5%) 1616
Females n% 25(73.6%)25(73.6%) 9(26.4%)9(26.4%) 3434
Smoking (n%) 2(20.0%)2(20.0%) 8(80.0%)8(80.0%) 1010 0.0070.007
BMI 31.64 ± 3.8831.64 ± 3.88 29.21 ± 5.6029.21 ± 5.60 30.72 ± 4.7130.72 ± 4.71 NSNS
Diabetes duration:
0.0010.001< 10 years 22(84.6%)22(84.6%) 4(15.4%)4(15.4%) 2626
≥ 10years 9(37.5%)9(37.5%) 15(62.5%)15(62.5%) 2424
Insulin use (n%) 25(61.0%)25(61.0%) 16(39.0%)16(39.0%) 4141 NSNS
Retinopathy (n%) 10(50%)10(50%) 10(50%)10(50%) 2020 NSNS
Hypertension 10(47.6%)10(47.6%) 11(53.4%)11(53.4%) 2121 NSNS
Ischemic heart disease 6(42.9%)6(42.9%) 8(57.1%)8(57.1%) 1414 NSNS
Nephropathy 6(35.3%)6(35.3%) 11(64.7%)11(64.7%) 1717 0.0050.005
Table(1)Baseline characteristics of patients with healed and unhealed ulcers

22. Variable Healed( n=31) Unhealed n=19 Total P-value
Sever neuropathy(n % 4(30.7%) 9(69.3%) 13 0.018
ABI 0.93±0.05 0.75±0.09 0.86±0.8 0.000
Colour change (n%) 1(10%) 9(90.0%) 10 0.001
Superficial infection 8(53.3%) 7(46.7%) 15 NS
Deep infection 2(20%) 8(80%) 10 0.007
Ulcer site:
For foot 10(32.2%) 3(15.8%) 13 NS
Mid foot 4(12.9%) 4(21%) 8 NS
Hind foot 6(19.3%) 7(36.8%) 13 NS
Toes 8(25.8%) 4(21%) 12 NS
Dorsum 3(9.6%) 1(5.2%) 4 NS
Ulcer extent
0.0091-5cm 23(76.7%) 7(23.3%) 30
>5cm 8(40.0%) 12(60.0%) 20
Ulcer duration
0.001
<1 week 15(88.3%) 2(11.7%) 17
1 week-3months 13(68.4%) 6(31.6%) 19
>3 months 3(21.4%) 11(78.6%) 14
Table(2)Baseline characteristics of ulcer examination and
relation to healing

23. Variable Healed Unhealed Total p. value
Ulcer depth (n%)
0.005
Grade.1 16(88.9%) 2(11.1%) 18
Grade.2 13(54.2%) 11(45.8%) 24
Grade.3 2(25.0%) 6(75.0%) 8
Texas class. (n%)
1A+2A 21(84%) 4(16%) 25 0.001
2D+3D 1(10.0%) 9(90.0%) 10 0.001
Wagner class. (n%):
0.001
Grade 1 16(88.9%) 2(11.1%) 18
Grade 2 13(59.1%) 9(40.9%) 22
Grade 3 2(20%) 8(80%) 10
Base line characteristics of ulcer examination and relation to healing
(cont.)

24. Table (3) aboratory data and relation to healing
Variable UnHealed n=19 Healed n=31 P-value
Urea mmol/L 8.09 ± 2.63 6.68 ± 1.94 NS
S.Creatinine umol/L 206.63 ± 165.50 93.36 ± 36.60 0.001
Cr.Clearance ml/min 56.25 ± 32.07 92.53 ± 27.18 0.000
24 hr protein in urine mg/l 442.42 ± 226.22 229.71 ± 149.42 0.000
WBCS k/ul 11.39 ± 3.90 7.33 ± 2.04 0.000
Hgb gm/dl 10.11 ± 1.73 11.62 ± 1.08 0.004
Platelets k/ul 247.00 ± 28.93 235.10 ± 27.07 NS
Hb A1c H% 12.88 ± 2.03 8.06 ± 0.99 0.008
Serum albumin g/l 26.28 ± 5.87 30.69 ± 4.37 0.004
Bilirubin umol/l 11.31 ± 3.05 10.97 ± 2.61 NS
ALT Iu/l 20.31 ± 4.81 15.72 ± 6.20 NS
AST Iu/l 18.03 ± 6.46 16.65 ± 5.95 NS
S. Cholest mg/dl 228.47 ± 67.16 189.39 ± 45.35 0.010
TG mg/dl 162.56 ± 40.69 139.42 ± 87.64 0.000
HDLmg/dl 37.49 ± 8.07 43.15 ± 8.60 0.000
LDLmg/dl 113.42 ± 29.78 95.92 ± 16.14 0.048

25. Predictor variablePredictor variable
Outcome:Outcome: unhealingunhealing
Sig.Sig. OROR 95.0%C.I.95.0%C.I.
Duration of diabetes: > 10 yrsDuration of diabetes: > 10 yrs 0.008*0.008* 2.162.16 1.02-2.611.02-2.61
Male sexMale sex 0.024*0.024* 1.111.11 1.03-2.861.03-2.86
Sever p.neuropathySever p.neuropathy 0.012*0.012* 1.131.13 0.89-1.460.89-1.46
Texas grade 2D, 3DTexas grade 2D, 3D 0.004*0.004* 1.241.24 1.15-3.241.15-3.24
Wagner grade-3Wagner grade-3 0.005*0.005* 1.181.18 1.09-2.981.09-2.98
>3 months Ulcer duration>3 months Ulcer duration 0.013*0.013* 1.121.12 1.33-2.851.33-2.85
ABI< 0.8ABI< 0.8 0.006*0.006* 1.161.16 1.05-2.681.05-2.68
Table (4)Multivariate regression analysis of predictor
variables towards unhealing.

27. Case (1Case (1((

28. Case (2Case (2((

29. Case (3Case (3((

30. Case 4

31. Case 5

32. Case 6

33. Unhealed casesUnhealed cases

34. Conclusion
 In conclusion, the major findings from this
study are, male sex, duration of diabetes
≥10years, sever pripheral neuropathy, ulcer
duration>3month,Wagner grade3,Texas
grade2D,3D and limb ischemia as ABI<0.8
independently predict poor outcome
(unhealing) of diabetic foot ulcer .

35. ReferencesReferences
1-Abbot CA , Carrington AL Ashe H ,1-Abbot CA , Carrington AL Ashe H , BathsBaths ,, every l.c Giriffiths J , HannAW,every l.c Giriffiths J , HannAW,
HussainA , JacksonN , Johnson KE . RyderHussainA , JacksonN , Johnson KE . Ryder CH , Tor kingtonR , van Ross ER ,CH , Tor kingtonR , van Ross ER ,
WALLEY AM , WIDDOWS P , Williamsons , Boulton AJ :WALLEY AM , WIDDOWS P , Williamsons , Boulton AJ :
The northThe north –– west diabetes foot care study : inciderce of , and risk factors for newwest diabetes foot care study : inciderce of , and risk factors for new
diabetic foot ulceration in acommunity . based patient cohort . Diabet Med 2002 ,diabetic foot ulceration in acommunity . based patient cohort . Diabet Med 2002 ,
19:377-389 .19:377-389 .
2-Boulton AJ , kirsner RS , vileikytel2-Boulton AJ , kirsner RS , vileikytel : clinical practice: neuropathic diabetic foot: clinical practice: neuropathic diabetic foot
ulcers . NE ngl J Med 2004 , 351ulcers . NE ngl J Med 2004 , 351:48-55 3-3:48-55 3-3
3-Nabuvrs- Franssen M H, Huijberts MS, Nieuwenhuijzn kruseman A C ,3-Nabuvrs- Franssen M H, Huijberts MS, Nieuwenhuijzn kruseman A C ,
Willems J, schaper N C ,Willems J, schaper N C , health- related quality of life of diabetic foot ulcer patientshealth- related quality of life of diabetic foot ulcer patients
and their caregivers . Diabefologia 2005 48 : 1906-1910and their caregivers . Diabefologia 2005 48 : 1906-1910
4-prompersl , Huijberts M, Apelqvist J4-prompersl , Huijberts M, Apelqvist J : optimal organization of heath care: optimal organization of heath care
indiabetic foot diseaseindiabetic foot disease
introduction to the eurodiale study . intj low extreme wounds 2007 6:11-17introduction to the eurodiale study . intj low extreme wounds 2007 6:11-17
6- Singh N , Armstrong DG , lipsky BA :6- Singh N , Armstrong DG , lipsky BA : preventing foot ulcers in patients withpreventing foot ulcers in patients with
diabetes JAMA 2005 293 : 217-228diabetes JAMA 2005 293 : 217-228