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Predictors of the outcome of
diabetic foot ulcer at Assiut
    university hospital
                            By
          Walaa Anwar Muhammad Khalifa
                      M.B.B.CH
                      M.ScFaculty of medicine
                      M.ScFaculty
                       Assiut University
                   Under supervision of
            Prof. Dr. Lobna Farag Eltoony
   Professor of internal medicine&head of endocrinology unit
                       Faculty of medicine
                         Assiut University
              Dr. Mona Muhammad Soliman
                  Lecturer of internal medicine
                       Faculty of medicine
                        Assiut University
Introduction
   Diabetic foot ulcers are a common and much
    feared complication of diabetes, with recent
    studies suggesting that the lifetime risk of
    developing foot ulcer in diabetic patients may be
    as high as 25% (Singh et al.,2005).
   Up to 50% of older patients with type 2 diabetes
    have one or more risk factors for foot ulceration.
   A list of the principal risk factors that might
    result in foot ulcer development are
    demonstrated ( Abbott et al ., 2002.)
Risk factors of foot ulcer
1- Previous amputation.
2- Past history of foot ulceration.
3- Peripheral neuropathy.
4- Peripheral vascular disease.
5- Foot deformity.
6- Visual impairment.
7- Diabetic nephropathy.
8- Poor glycemic control.

9- Cigarette smoking
   The most common triad of causes that

    interact and result in foot ulceration has

    been identified as neuropathy, deformity

    and trauma ( Boulton et al., 2004)
• The risk of amputation is 15 to 40 times
  greater in a person with diabetes than in
  one who doesn't have the disease
( Nabuurs et al..2005).
 The population of diabetic patients who
        present with foot ulceration are
heterogenous,there are characteristics that
     may vary among patients, such as the
    presence of peripheral arterial disease
infection,andco-morbidities.
   Peripheral arterial disease is considered
        an important predictor of outcome
                    (Prompers et al., 2007).
   Therefore. Outcome data on these patients
    with diabetic foot ulcer are needed such a
    requirement is underlined by the fact that
    although diabetic foot ulcers are usually
    reported and analyzed as one clinical
    entity marked differences in patient, foot
    and ulcer characteristics can exist between
    patients. These observations raise the
    question of wether predictors of outcome in
    patients may differ (Prompers et al., 2007).
The aim of the study
   To assess the potential baseline clinical and
    laboratory characteristics that best predict poor
    outcome (non healing of the foot ulcer).
   The main outcome of the study is complete
    healing of the foot within the maximum follow
    up period of 1 year.
   Healing was defined as healing (intact skin) of
    the whole foot at two consecutive visits.
Patients & study design
   It is a prospective study in which 100
    patients with diabetic foot ulcer will be
    followed and managed for 1 year.
    About 50 patients are still under
    research.
   Patients included were those presenting
    for the first time with a new foot ulcer
    within period of 12 months.
Excluded patients
1- Patients who had been treated for an
  ulcer on the ipsilateral foot during the
   previous 12 months.
2- Patients with sever end organ
  failure.
3- Patients with gangrenous foot. eg,
  gas gangrene.
Method
   Data collected prospectively of patients
    referred to a foot care clinic
                                         recorded
    Data include.
   Demographics,detailed history and complete
    physical examination
   Data on co- morbidities including ( retinopathy
    nephropathy, hypertension and ischemic heart
    disease) .
  Data on foot examination
   include.
 (foot inspection, Pedal
   pulse, ABI measurement
   and joint examination).
 Data on ulcer
   characteristics.
 ulcers were classified
   according to
1-PEDIS system.
 ( perfusion, extent, depth,
   infection and sensation ) .
-2Meggitt- wagner classification of
                 foot ulcers
Grade0:Pre- or post- ulcerative lesion
  completely epithelialized
Grade1:Superficial, full thickness ulcer limited
  to the dermis, not extending to the subcutis
Grade 2:Ulcer of the skin extending through the
  subcutis with exposed tendon or bone and
  without osteomyelitis or abscess
Grade 3:Deep ulcers with osteomyelitis or
  abscess formation
Grade 4:Localized gangrene of the toes or the
  forefoot
Grade 5:Foot with extensive gangrene
3- The university of Texas classification 1998
                                         Grade
    Stage
                  0               1              2             3
             Pre- or post-   Superficial   Wound          Wound
      A      ulcerative      wound not     penetrating    penetrating
             lesion          involving     to tendon or   to bone or
             completely      tendon,       capsule        joint
             epithelailizd   capsule or
                             bone
             With            With          With           With
      B      infection       infection     infection      infection
             With            With          With           With
      C      ischemia        ischemia      ischemia       ischemia
             With            With          With           With
      D      infection       infection     infection      infection
             and             and           and            and ischemia
             ischemia        ischemia      ischemia
   Laboratory data include
    Complete blood picture, liver
    function, urea and creatinine ,24
    hrs proteins in urine, creatinine
    clearance, lipogram and (Hb A1c)
.
Management of diabetic foot ulcer

All Patients were treated According to protocols based
  on the international consensus on the diabetic foot
  which include offloading ,diagnosis and treatment of
  infection, assessment of vascular status and regular
  wound debridement .
Results of 50 patients:
In 50 patients: 34 (68%) females ,
the mean age 50.76 ± 13.35.
Diagram (2) :shows results of patient




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                                                  no. of cases
Diagram(3):shows results of
      foot inspection
Table(1)Baseline characteristics of patients with healed and unhealed ulcers
                            Healed         Unhealed          Total
        Variable                                                          P-value
                            (n= 31)         (n= 19)         (n= 50)
 Age:                     47.39 ± 11.42   56.26 ± 16.76   50.76 ± 13.35    0.021
 Sex:
  Males n%                 6(37.5%)        10(62.5%)           16          0.014
  Females n%               25(73.6%)       9(26.4%)            34
 Smoking (n%)              2(20.0%)        8(80.0%)            10          0.007
 BMI                      31.64 ± 3.88    29.21 ± 5.60    30.72 ± 4.71      NS
 Diabetes duration:
  < 10 years               22(84.6%)       4(15.4%)            26          0.001
  ≥ 10years                9(37.5%)        15(62.5%)           24
 Insulin use (n%)          25(61.0%)       16(39.0%)           41           NS
 Retinopathy (n%)           10(50%)         10(50%)            20           NS
 Hypertension              10(47.6%)       11(53.4%)           21           NS
 Ischemic heart disease    6(42.9%)        8(57.1%)            14           NS
 Nephropathy               6(35.3%)        11(64.7%)           17          0.005
Table(2)Baseline characteristics of ulcer examination and
relation to healing
  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
    1-5cm                23(76.7%)       7(23.3%)      30    0.009
    >5cm                  8(40.0%)     12(60.0%)       20
  Ulcer duration
    <1 week              15(88.3%)      2(11.7%)       17
                                                             0.001
    1 week-3months       13(68.4%)      6(31.6%)       19
    >3 months             3(21.4%)     11(78.6%)       14
Base line characteristics of ulcer examination and relation to healing
(cont.)
       Variable           Healed       Unhealed      Total p. value
 Ulcer depth (n%)
   Grade.1               16(88.9%)      2(11.1%)      18
                                                              0.005
   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%):
   Grade 1               16(88.9%)      2(11.1%)      18
                                                              0.001
   Grade 2               13(59.1%)      9(40.9%)      22
   Grade 3                2(20%)         8(80%)       10
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
Table (4)Multivariate regression analysis of predictor
.variables towards unhealing

                                          Outcome: unhealing
       Predictor variable
                                  Sig.           OR        95.0%C.I.
Duration of diabetes: > 10 yrs   0.008*          2.16          1.02-2.61

Male sex                         0.024*          1.11          1.03-2.86

Sever p.neuropathy               0.012*          1.13          0.89-1.46

Texas grade 2D, 3D               0.004*          1.24          1.15-3.24

Wagner grade-3                   0.005*          1.18          1.09-2.98

>3 months Ulcer duration         0.013*          1.12          1.33-2.85

ABI< 0.8                         0.006*          1.16          1.05-2.68
(Case (1
(Case (2
(Case (3
Case 4
Case 5
Case 6
Unhealed cases
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 .
References
1-Abbot CA , Carrington AL Ashe H , Baths , every l.c Giriffiths J , HannAW,
HussainA , JacksonN , Johnson KE . Ryder CH , Tor kingtonR , van Ross ER ,
WALLEY AM , WIDDOWS P , Williamsons , Boulton AJ :
The north – west diabetes foot care study : inciderce of , and risk factors for new
diabetic foot ulceration in acommunity . based patient cohort . Diabet Med 2002 ,
19:377-389 .
2-Boulton AJ , kirsner RS , vileikytel : clinical practice: neuropathic diabetic foot
ulcers . NE ngl J Med 2004 , 351:48-55 3-3
3-Nabuvrs- Franssen M H, Huijberts MS, Nieuwenhuijzn kruseman A C ,
Willems J, schaper N C , health- related quality of life of diabetic foot ulcer patients
and their caregivers . Diabefologia 2005 48 : 1906-1910
4-prompersl , Huijberts M, Apelqvist J : optimal organization of heath care
indiabetic foot disease
introduction to the eurodiale study . intj low extreme wounds 2007 6:11-17
6- Singh N , Armstrong DG , lipsky BA : preventing foot ulcers in patients with
diabetes JAMA 2005 293 : 217-228
Predictors of Outcome for Diabetic Foot Ulcers

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Predictors of Outcome for Diabetic Foot Ulcers

  • 1.
  • 2. Predictors of the outcome of diabetic foot ulcer at Assiut university hospital By Walaa Anwar Muhammad Khalifa M.B.B.CH M.ScFaculty of medicine M.ScFaculty Assiut University Under supervision of Prof. Dr. Lobna Farag Eltoony Professor of internal medicine&head of endocrinology unit Faculty of medicine Assiut University Dr. Mona Muhammad Soliman Lecturer of internal medicine Faculty of medicine Assiut University
  • 3. Introduction  Diabetic foot ulcers are a common and much feared complication of diabetes, with recent studies suggesting that the lifetime risk of developing foot ulcer in diabetic patients may be as high as 25% (Singh et al.,2005).  Up to 50% of older patients with type 2 diabetes have one or more risk factors for foot ulceration.  A list of the principal risk factors that might result in foot ulcer development are demonstrated ( Abbott et al ., 2002.)
  • 4. Risk factors of foot ulcer 1- Previous amputation. 2- Past history of foot ulceration. 3- Peripheral neuropathy. 4- Peripheral vascular disease. 5- Foot deformity. 6- Visual impairment. 7- Diabetic nephropathy. 8- Poor glycemic control. 9- Cigarette smoking
  • 5.
  • 6. The most common triad of causes that interact and result in foot ulceration has been identified as neuropathy, deformity and trauma ( Boulton et al., 2004)
  • 7. • The risk of amputation is 15 to 40 times greater in a person with diabetes than in one who doesn't have the disease ( Nabuurs et al..2005).
  • 8.  The population of diabetic patients who present with foot ulceration are heterogenous,there are characteristics that may vary among patients, such as the presence of peripheral arterial disease infection,andco-morbidities. Peripheral arterial disease is considered an important predictor of outcome (Prompers et al., 2007).
  • 9. Therefore. Outcome data on these patients with diabetic foot ulcer are needed such a requirement is underlined by the fact that although diabetic foot ulcers are usually reported and analyzed as one clinical entity marked differences in patient, foot and ulcer characteristics can exist between patients. These observations raise the question of wether predictors of outcome in patients may differ (Prompers et al., 2007).
  • 10. The aim of the study  To assess the potential baseline clinical and laboratory characteristics that best predict poor outcome (non healing of the foot ulcer).  The main outcome of the study is complete healing of the foot within the maximum follow up period of 1 year.  Healing was defined as healing (intact skin) of the whole foot at two consecutive visits.
  • 11. Patients & study design  It is a prospective study in which 100 patients with diabetic foot ulcer will be followed and managed for 1 year.  About 50 patients are still under research.  Patients included were those presenting for the first time with a new foot ulcer within period of 12 months.
  • 12. Excluded patients 1- Patients who had been treated for an ulcer on the ipsilateral foot during the previous 12 months. 2- Patients with sever end organ failure. 3- Patients with gangrenous foot. eg, gas gangrene.
  • 13. Method  Data collected prospectively of patients referred to a foot care clinic recorded Data include.  Demographics,detailed history and complete physical examination  Data on co- morbidities including ( retinopathy nephropathy, hypertension and ischemic heart disease) .
  • 14.  Data on foot examination include. (foot inspection, Pedal pulse, ABI measurement and joint examination).  Data on ulcer characteristics. ulcers were classified according to 1-PEDIS system. ( perfusion, extent, depth, infection and sensation ) .
  • 15. -2Meggitt- wagner classification of foot ulcers Grade0:Pre- or post- ulcerative lesion completely epithelialized Grade1:Superficial, full thickness ulcer limited to the dermis, not extending to the subcutis Grade 2:Ulcer of the skin extending through the subcutis with exposed tendon or bone and without osteomyelitis or abscess Grade 3:Deep ulcers with osteomyelitis or abscess formation Grade 4:Localized gangrene of the toes or the forefoot Grade 5:Foot with extensive gangrene
  • 16. 3- The university of Texas classification 1998 Grade Stage 0 1 2 3 Pre- or post- Superficial Wound Wound A ulcerative wound not penetrating penetrating lesion involving to tendon or to bone or completely tendon, capsule joint epithelailizd capsule or bone With With With With B infection infection infection infection With With With With C ischemia ischemia ischemia ischemia With With With With D infection infection infection infection and and and and ischemia ischemia ischemia ischemia
  • 17. Laboratory data include Complete blood picture, liver function, urea and creatinine ,24 hrs proteins in urine, creatinine clearance, lipogram and (Hb A1c) .
  • 18. Management of diabetic foot ulcer All Patients were treated According to protocols based on the international consensus on the diabetic foot which include offloading ,diagnosis and treatment of infection, assessment of vascular status and regular wound debridement .
  • 19. Results of 50 patients: In 50 patients: 34 (68%) females , the mean age 50.76 ± 13.35.
  • 20. Diagram (2) :shows results of patient s om pt m sy c hi at op ur ne p y ra characteristics e th lin su in n tio ta pu am of y or st hi st pa s er ok sm n- no 0 50 40 30 20 10 no. of cases
  • 21. Diagram(3):shows results of foot inspection
  • 22. Table(1)Baseline characteristics of patients with healed and unhealed ulcers Healed Unhealed Total Variable P-value (n= 31) (n= 19) (n= 50) Age: 47.39 ± 11.42 56.26 ± 16.76 50.76 ± 13.35 0.021 Sex: Males n% 6(37.5%) 10(62.5%) 16 0.014 Females n% 25(73.6%) 9(26.4%) 34 Smoking (n%) 2(20.0%) 8(80.0%) 10 0.007 BMI 31.64 ± 3.88 29.21 ± 5.60 30.72 ± 4.71 NS Diabetes duration: < 10 years 22(84.6%) 4(15.4%) 26 0.001 ≥ 10years 9(37.5%) 15(62.5%) 24 Insulin use (n%) 25(61.0%) 16(39.0%) 41 NS Retinopathy (n%) 10(50%) 10(50%) 20 NS Hypertension 10(47.6%) 11(53.4%) 21 NS Ischemic heart disease 6(42.9%) 8(57.1%) 14 NS Nephropathy 6(35.3%) 11(64.7%) 17 0.005
  • 23. Table(2)Baseline characteristics of ulcer examination and relation to healing 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 1-5cm 23(76.7%) 7(23.3%) 30 0.009 >5cm 8(40.0%) 12(60.0%) 20 Ulcer duration <1 week 15(88.3%) 2(11.7%) 17 0.001 1 week-3months 13(68.4%) 6(31.6%) 19 >3 months 3(21.4%) 11(78.6%) 14
  • 24. Base line characteristics of ulcer examination and relation to healing (cont.) Variable Healed Unhealed Total p. value Ulcer depth (n%) Grade.1 16(88.9%) 2(11.1%) 18 0.005 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%): Grade 1 16(88.9%) 2(11.1%) 18 0.001 Grade 2 13(59.1%) 9(40.9%) 22 Grade 3 2(20%) 8(80%) 10
  • 25. 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
  • 26. Table (4)Multivariate regression analysis of predictor .variables towards unhealing Outcome: unhealing Predictor variable Sig. OR 95.0%C.I. Duration of diabetes: > 10 yrs 0.008* 2.16 1.02-2.61 Male sex 0.024* 1.11 1.03-2.86 Sever p.neuropathy 0.012* 1.13 0.89-1.46 Texas grade 2D, 3D 0.004* 1.24 1.15-3.24 Wagner grade-3 0.005* 1.18 1.09-2.98 >3 months Ulcer duration 0.013* 1.12 1.33-2.85 ABI< 0.8 0.006* 1.16 1.05-2.68
  • 27.
  • 35. 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 .
  • 36. References 1-Abbot CA , Carrington AL Ashe H , Baths , every l.c Giriffiths J , HannAW, HussainA , JacksonN , Johnson KE . Ryder CH , Tor kingtonR , van Ross ER , WALLEY AM , WIDDOWS P , Williamsons , Boulton AJ : The north – west diabetes foot care study : inciderce of , and risk factors for new diabetic foot ulceration in acommunity . based patient cohort . Diabet Med 2002 , 19:377-389 . 2-Boulton AJ , kirsner RS , vileikytel : clinical practice: neuropathic diabetic foot ulcers . NE ngl J Med 2004 , 351:48-55 3-3 3-Nabuvrs- Franssen M H, Huijberts MS, Nieuwenhuijzn kruseman A C , Willems J, schaper N C , health- related quality of life of diabetic foot ulcer patients and their caregivers . Diabefologia 2005 48 : 1906-1910 4-prompersl , Huijberts M, Apelqvist J : optimal organization of heath care indiabetic foot disease introduction to the eurodiale study . intj low extreme wounds 2007 6:11-17 6- Singh N , Armstrong DG , lipsky BA : preventing foot ulcers in patients with diabetes JAMA 2005 293 : 217-228