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Topical Insulin Versus Irradiated Amniotic Fluid Gel for Wound Healing in Epidermolysis Bullosa
Sponsor: Tanta University
Summary
This study aims to evaluate and compare the safety and efficacy of topical insulin and topical irradiated amniotic fluid gel in promoting wound healing in patients with epidermolysis bullosa (EB). Thirty patients with confirmed EB and suitable non-infected wounds were recruited from the Dermatology and Venereology Department, Tanta University Hospitals, Egypt. Wounds were assessed before and after treatment using wound surface area measurements, pain scores, clinical evaluation, and photographic documentation. Treatment was administered weekly for four consecutive weeks, with subsequent follow-up assessments. An untreated wound group served as the control. The study also evaluated patient satisfaction and treatment-related adverse effects.
Official title: A Study of Safety and Efficacy of Topical Insulin Versus Topical Irradiated Amniotic Fluid Gel for Treatment of Epidermolysis Bullosa Patients
Key Details
Gender
All
Age Range
1 Year - 21 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-01-01
Completion Date
2026-01-01
Last Updated
2026-10-30
Healthy Volunteers
No
Interventions
Topical Insulin (Actrapid®)
Rapid-acting human insulin (100 IU/mL), with 1 mL applied directly to the wound surface during each session. The wound was covered with Vaseline gauze and secured with a gauze wrap. Treatment was administered weekly for four consecutive weeks.
Topical Irradiated Amniotic Fluid Gel
Irradiated amniotic fluid gel manufactured by the Egyptian Atomic Energy Authority. A volume of 1 mL was applied directly to the wound surface during each session, followed by coverage with Vaseline gauze and a gauze wrap. Treatment was administered weekly for four consecutive weeks.
No active study treatment
No active study product was applied. Wounds were covered with Vaseline gauze and secured with a gauze wrap.
Locations (1)
Tanta University Hospitals
Tanta, Egypt