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1362574160 dr. vijay viswanathan

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dr. vijay viswanathan

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1362574160 dr. vijay viswanathan

  1. 1. Dr. Vijay Viswanathan, M.D, Ph.D., MNAMS Joint Director Diabetes Research Centre & M. V. Hospital for Diabetes Chennai. WHO Collaborating Centre for Research, Education & Training in diabetes
  2. 2.  Chronic wounds provide a more complex challenge:  fluxes in the local non – healing wound environment in which growth factors can quickly become trapped  degraded by the proteolytic extracellular milieu. [Trengove NJ et al., Wound Repair Regen 1999; 7: 442 – 452]  Certain growth factors are selectively inhibited in the ulcer environment.
  3. 3. Treatment Modality Reference No. of patients examined Method of trial Method of action Results Platelet – derived growth factor – BB (Becaplermin) Becaplermin 0.01% 272 Control - 236 Meta – analysis of 4 RCT’s Enhances granulation tissue formation and facilities epithelialization A significant reduction in healing time. Significantly more healing in wounds < 5 cm Epidermal growth factor (EGF) EGF – 21 Placebo - 19 RCT A potent dose – dependent mitogen for granulation fibroblasts contributing to wound healing and closure Significantly faster wound closure and healing after 12 weeks of therapy Tsang MW et al., Diabetes Care 2003; 26: 1856 – 1861 RCT’s and clinical trials published on growth factors Smiell JM et al., Wound Repair Regen 1999; 7: 335 - 346
  4. 4.  Epidermal growth factor belongs to: A family of growth factors that regulate cell proliferation  migration  differentiation through binding to receptor kinases on target cells
  5. 5.  Epidermal growth factor peptide induces cellular proliferation through the EGF receptor:  EGF receptor: Has a tyrosine kinase cytoplasmic domain  Extracellular domain involved in EGF binding and receptor dimerization. Mechanism of action
  6. 6.  Binding of EGF results in:  EGF receptor dimerization  autophosphorylation of the receptor  tyrosine phosphorylation of other proteins
  7. 7.  Epidermal growth factor receptor activates  MAP kinase pathway  ultimately causing phosphorylation of transcription factors such as c – Fos  to create AP – 1  ELK – 1 that contribute to proliferation
  8. 8.  Healthy male or female patients between 18 – 65 years at the time of consent  Patients with controlled diabetes mellitus having foot ulcers  The target ulcer is no less than 2 cm2 and no more than 50 cm2  Patients with ABI > 0.8  Ulcers, which remain opened without healing for more than 2 – 3 weeks A Phase III Study to Evaluate the Safety and Efficacy of Recombinant Human Epidermal Growth Factor ( REGEN-D TM – 150 ) in Healing Diabetic foot Ulcers Vijay Viswanathan, Sharad Pendsey, N.Sekar, G.S.R. Murthy [ WOUNDS:,Vol.18, No.7 July 2006 ]
  9. 9. EXCLUSION CRITERIA  Patients with > Wagner’s grade III classification  Pregnant women and nursing mothers  Uncontrolled diabetes mellitus  Treatment with a dressing containing other growth factors or biological dressings within 30 days prior to the screening visit.
  10. 10. Epidermal Growth Factor : Diabetic Foot Ulcer Trial summary Total no. of patients - 57 • Group 1 (EGF) - 29 • Group 2 (Control) - 28 Group 1 Group 2 p value No. of patients 29 28 M / F 22 / 7 20 / 8 Mean age (in yrs) 58 ± 1.9 59 ± 2.0 Ulcer size (in cm2 ) 13.3 ± 3.1 12.5± 2.2 No of Healed cases at 15 weeks 25 12 < 0.01 Mean healing time (days) 56.8 ± 4.7 81± 4.4 < 0.01 Values are Mean ± SD
  11. 11. Week, w Percentageofpatientscuredbyweekw 282420161284 100 80 60 40 20 0 Figure-5: Efficacy of Regen-D Gel Cont rol Test Figure 5 : The healing takes place before the end of the 8th week in 50% of the patients under test; and it takes nearly 15 weeks to cure 50% of the patients under control. Percentageofpatientswhohadcomplete healing(inweeks)
  12. 12. 0 10 20 30 40 Condition Area Control ControlTest Test %Healedwithin15weeks 88% 100% 8% 66% 0 - 6 Above 6 Control : Placebo. Test: rhEGF Comparison of placebo and rhEGF by ulcer area
  13. 13. Post – Marketing Survey (PMS) Study comparison with Phase III Clinical Data 0 20 40 60 80 100 5 10 15 20 25 30 Week (w) Percentageofpatientscuredbyweek(w) Cumulative percentages of curing Control Test PMS
  14. 14. •65 year old female •Ulcer on the dorsum of left foot – one month duration •Size: 1 x 2.5 cms Visit 1
  15. 15. • Size: 0.4 x 1.5 cms Visit 4 (Week 3)
  16. 16. • Wound has healed completely Visit 6 (Week 5)
  17. 17. • 65 year old male • Chronic non healing ulcer for 2 months duration over the lateral malleolus of the right foot •Size: 5 x 6.5 cms Visit 1
  18. 18. • Size: 2.2 x 1 cms Visit 6 (Week 5)
  19. 19. • The ulcer completely healed in 8 weeks.
  20. 20. • 63 year old female • Tropic ulcer in the region of left fifth metatarsal • Duration of the ulcer: 1 month • Size: 2.5 x 2 cms Visit 1
  21. 21. • Size: 1.3 x 1.3 cms Visit 3 (Week 2)
  22. 22. • Wound measured about 0.4 x 0.3 cms. • Totally healed in a weeks time. Visit 5 (Week 4)
  23. 23. [Courtesy, Sharad Pendsey, Nagpur]
  24. 24. [Courtesy, Sharad Pendsey, Nagpur]
  25. 25. “I dressed the wound and God healed it” Ambrose Pare

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