NCT07466576

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

A Prospective Clinical Trial Evaluating the Clinical Outcomes of Air-Dried Human Amniotic Membrane Sterilized With Different Gamma Irradiation Doses in the Treatment of Chronic Wounds

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Libyan Center for Biotechnology Research · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Detailed Description Human amniotic membrane (hAM) is widely utilized in regenerative medicine due to its anti-inflammatory, anti-fibrotic, antimicrobial, and proepithelialization properties. It serves as a natural extracellular matrix scaffold enriched with growth factors and bioactive molecules that promote tissue repair and modulate the healing process. Ensuring sterility while preserving structural integrity and biological activity is essential for safe and effective clinical application. Gamma irradiation is a well-established terminal sterilization method capable of achieving a high sterility assurance level. However, different irradiation doses may influence the mechanical strength, ultrastructural integrity, and biological properties of the membrane. Therefore, this prospective randomized interventional clinical study is designed to evaluate the safety and therapeutic effectiveness of air-dried human amniotic membrane sterilized at three different gamma irradiation doses: 15 kGy, 20 kGy, and 25 kGy. The study includes two independent clinical cohorts conducted under a unified protocol: 1\. Diabetic Foot Ulcer (DFU) Cohort Participants with chronic diabetic foot ulcers will be randomly assigned to receive air-dried hAM sterilized at 15 kGy, 20 kGy, or 25 kGy. The membrane will be applied as a biological wound dressing in addition to standard wound care. Clinical evaluation will include rate of complete wound closure, percentage reduction in wound area, time to full epithelialization, infection rate, pain reduction, and overall quality of tissue regeneration. Comparative analysis will be performed to assess potential dose-response effects across both cohorts. The primary objective of the study is to determine the optimal gamma irradiation dose that ensures effective sterilization while preserving the biological functionality and regenerative capacity of the membrane. The findings are expected to support the development of a safe, ready-to-use, room-temperature stable biological graft suitable for multidisciplinary clinical applications, particularly in chronic wound management and ocular surface reconstruction.

Conditions

• Diabetic Foot Ulcer (DFU)

Interventions

Type	Name	Description
BIOLOGICAL	Air-Dried Human Amniotic Membrane (AD-hAM)	Air-dried human amniotic membrane terminally sterilized using cobalt-60 gamma irradiation (20-25 kGy). The membrane is applied as a biological graft for regenerative clinical use, including diabetic foot ulcers and corneal ulcers. Each participant receives a single application during the study period.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-07-30
• Completion: 2026-08-02
• First posted: 2026-03-12
• Last updated: 2026-03-12