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EEFFICACYFFICACY OO FF RRECO MBINANTECO MBINANT HHUMANUMAN
EEPIDERMALPIDERMAL GG RO WTHRO WTH FFACTO RACTO R
IINN
HHEALINGEALING DDIABETICIABETIC FFO O TO O T UULCERS –LCERS –
BBIO CHEMICALIO CHEMICAL AANDND MMO LECULARO LECULAR AANALYSIS –NALYSIS –
PPRELIMINARYRELIMINARY RRESULTSESULTS
* Dr.Rajesh Kesavan
* Dr.Vijay Viswanathan
#
Dr.Mary Babu
#
Ms. Ramya
* Ms.Sivagami
* MV Hospital for Diabetes and Diabetes
Research Centre, Royapuram, Chennai
#
Central Leather Research Institute,
Chennai
DYNAMIC
REPARATIVE
PROCESS
ORDERLY
WOUND
HEALING INTERACTIVE
CELL RECRUITMENT IN WOUNDS
Platelets Neutrophils
Macrophages
Fibroblasts
Lymphocytes
Post Wound Days
COMPONENTS OF WOUND HEALING
Coagulation
process
Inflammatory
process
Migratory /
Proliferative
process
Remodeling
process
Cell Types Involved
Platelets
Platelets
Macrophages
Neutrophils
Macrophages
Lymphocytes
Fibroblasts
Epithelial cells
Endothelial cells
Fibroblasts
Injury Hours Days Weeks
WOUND HEALING involves
 Leucocytes
 Extracellular Matrix
 Fibroblasts
 Macrophages
 Epithelial cells
 Endothelial cells
 Cytokines / Growth factors
Recombinant Human Epidermal Growth Factor
Aim
To validate the efficacy of Recombinant
Human Epidermal Growth Factor in healing of
Diabetic Foot Ulcers at Biochemical and
Molecular levels
Study Design
 Two groups - Intervention group and
Control group
 8 patients in each group
 Randomized single blind study
 Clinically uninfected foot ulcers in
patients with type II diabetes
 Ulcer size between 5 to 20 cm
diameter
 ABI > 0.8
 Ethics committee approval and
patient consent
Methodology
 Rh-EGF ointment - Intervention
group
 Placebo ointment - Control group
 Patients were instructed to dress the
wounds everyday
 Standard offloading methods followed
where appropriate
 Punch biopsy at Day 0 and Day 14
 Patients reviewed every week
Histologic analysis
 Matrix alignment
 Cellular infiltration
 Differentiation of Epithelial layers
Biochemical analysis
 Quantitative estimation of Collagen /
Proteoglycans
Total no. of patients = 16
Group 1 (EGF) = 8
Group 2 (Placebo) = 8
Group 1Group 1 Group 2Group 2 pp
No. of patientsNo. of patients 8 8
Age (in years)Age (in years) 56.1 (11.9) 56.6 (8.5) NS
Duration of DMDuration of DM 17.7 (6.6) 15.4 (5.8) NS
Mean length (inMean length (in
cm)cm)
5.4 (2.9) 2.6 (0.7) 0.02
Mean Breadth (inMean Breadth (in
cm)cm)
3.7 (0.9) 1.7 (0.4) 0.00001
HealedHealed 3 (38%) 2 (25%)
Time taken to healTime taken to heal
(in days)(in days)
21 (5.1) 23 (7.5) NS
Results
Quantitative estimation of Collagen
TestTest
((µg/mg)µg/mg)
ControlControl
((µg/mg)µg/mg)
Day 0Day 0 0.83 0.87
Day 15Day 15 3.78 1.313
Day 1 Day 14
Day 1 Day 21
Day 1 Day 30
Day 1 Day 14
Conclusion
Preliminary results indicate that
 EGF increases collagen content of wounds
 EGF hastens deposition of collagen in a proper
whorled arrangement
 It increases the no. of fibroblasts seen in the
matrix
 Angiogenesis is more prominent in the EGF gp
 Chr. Inflammatory cells are seen in abundance
in the control group
 EGF accelerates healing in diabetic foot ulcers
Thank You !

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1362574355 egf study

  • 1. EEFFICACYFFICACY OO FF RRECO MBINANTECO MBINANT HHUMANUMAN EEPIDERMALPIDERMAL GG RO WTHRO WTH FFACTO RACTO R IINN HHEALINGEALING DDIABETICIABETIC FFO O TO O T UULCERS –LCERS – BBIO CHEMICALIO CHEMICAL AANDND MMO LECULARO LECULAR AANALYSIS –NALYSIS – PPRELIMINARYRELIMINARY RRESULTSESULTS
  • 2. * Dr.Rajesh Kesavan * Dr.Vijay Viswanathan # Dr.Mary Babu # Ms. Ramya * Ms.Sivagami * MV Hospital for Diabetes and Diabetes Research Centre, Royapuram, Chennai # Central Leather Research Institute, Chennai
  • 4. CELL RECRUITMENT IN WOUNDS Platelets Neutrophils Macrophages Fibroblasts Lymphocytes Post Wound Days
  • 5. COMPONENTS OF WOUND HEALING Coagulation process Inflammatory process Migratory / Proliferative process Remodeling process Cell Types Involved Platelets Platelets Macrophages Neutrophils Macrophages Lymphocytes Fibroblasts Epithelial cells Endothelial cells Fibroblasts Injury Hours Days Weeks
  • 6. WOUND HEALING involves  Leucocytes  Extracellular Matrix  Fibroblasts  Macrophages  Epithelial cells  Endothelial cells  Cytokines / Growth factors
  • 8. Aim To validate the efficacy of Recombinant Human Epidermal Growth Factor in healing of Diabetic Foot Ulcers at Biochemical and Molecular levels
  • 9. Study Design  Two groups - Intervention group and Control group  8 patients in each group  Randomized single blind study  Clinically uninfected foot ulcers in patients with type II diabetes  Ulcer size between 5 to 20 cm diameter  ABI > 0.8  Ethics committee approval and patient consent
  • 10. Methodology  Rh-EGF ointment - Intervention group  Placebo ointment - Control group  Patients were instructed to dress the wounds everyday  Standard offloading methods followed where appropriate  Punch biopsy at Day 0 and Day 14  Patients reviewed every week
  • 11. Histologic analysis  Matrix alignment  Cellular infiltration  Differentiation of Epithelial layers
  • 12. Biochemical analysis  Quantitative estimation of Collagen / Proteoglycans
  • 13. Total no. of patients = 16 Group 1 (EGF) = 8 Group 2 (Placebo) = 8 Group 1Group 1 Group 2Group 2 pp No. of patientsNo. of patients 8 8 Age (in years)Age (in years) 56.1 (11.9) 56.6 (8.5) NS Duration of DMDuration of DM 17.7 (6.6) 15.4 (5.8) NS Mean length (inMean length (in cm)cm) 5.4 (2.9) 2.6 (0.7) 0.02 Mean Breadth (inMean Breadth (in cm)cm) 3.7 (0.9) 1.7 (0.4) 0.00001 HealedHealed 3 (38%) 2 (25%) Time taken to healTime taken to heal (in days)(in days) 21 (5.1) 23 (7.5) NS Results
  • 14. Quantitative estimation of Collagen TestTest ((µg/mg)µg/mg) ControlControl ((µg/mg)µg/mg) Day 0Day 0 0.83 0.87 Day 15Day 15 3.78 1.313
  • 15.
  • 16.
  • 17.
  • 18.
  • 19. Day 1 Day 14
  • 20. Day 1 Day 21
  • 21. Day 1 Day 30
  • 22. Day 1 Day 14
  • 23. Conclusion Preliminary results indicate that  EGF increases collagen content of wounds  EGF hastens deposition of collagen in a proper whorled arrangement  It increases the no. of fibroblasts seen in the matrix  Angiogenesis is more prominent in the EGF gp  Chr. Inflammatory cells are seen in abundance in the control group  EGF accelerates healing in diabetic foot ulcers