Air-Dried Human Amniotic Membrane Terminally Sterilized by Gamma Irradiation for Multidisciplinary Clinical Application

This prospective interventional clinical study aims to evaluate the safety and therapeutic efficacy of air-dried human amniotic membrane (hAM) sterilized using different doses of gamma irradiation for regenerative medical applications. Gamma irradiation is employed as a terminal sterilization method to ensure microbiological safety while preserving the structural integrity and biological properties of the membrane. Within the same clinical protocol, the gamma-sterilized hAM will be applied to two distinct patient cohorts: individuals with diabetic foot ulcers (DFU) and patients with corneal ulcers. In the DFU cohort, the membrane will be used as a biological dressing to promote wound closure, enhance granulation tissue formation, reduce infection risk, and accelerate epithelialization. In the corneal ulcer cohort, the membrane will be applied to support corneal surface reconstruction, promote epithelial healing, reduce inflammation, and prevent complications. Participants in both cohorts will be monitored for clinical outcomes including rate of wound healing, time to complete epithelialization, infection rate, pain reduction, corneal re-epithelialization, and overall tissue regeneration quality. Clinical outcomes will be compared among membranes sterilized at different gamma irradiation doses to determine the optimal dose that ensures effective sterilization while maintaining biological activity and therapeutic performance.

NCT Number	NCT07466576
Lead Sponsor	Libyan Center for Biotechnology Research
Conditions	Diabetic Foot Ulcer (DFU), Ocular Disorder, Pterygium
Enrollment	2 participants
Start Date	2025-11-01
Primary Completion	2026-02-10 (estimated)
Study Completion	2026-07-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-29