Air-Dried Human Amniotic Membrane Terminally Sterilized by Gamma Irradiation for Multidisciplinary Clinical Application (GAMMA-AM)

March 9, 2026 updated by: Fawzi Ebrahim. PhD, Libyan Center for Biotechnology Research

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Patients requiring ocular surface reconstruction due to chemical/thermal burns, persistent epithelial defects, or conjunctival defects.

    2. Patients with chronic non-healing diabetic foot ulcers (DFU) of at least 4 weeks duration.

    3. Ability to understand the study procedures and provide written informed consent.

    4. For tissue donors (placenta): healthy mothers undergoing elective cesarean delivery with negative infectious disease screening (HIV, HBV, HCV, syphilis).

Exclusion Criteria:

  1. Active systemic infection or sepsis.
  2. Immunocompromised patients (HIV positive, ongoing immunosuppressive therapy).
  3. Pregnant or breastfeeding women.
  4. History of malignancy in the past 5 years.
  5. Known allergy or hypersensitivity to human amniotic tissue or materials used in graft preparation.

  6. Participation in another investigational clinical trial within 30 days prior to enrollment

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Air-Dried Human Amniotic Membrane
Participants receive gamma-sterilized air-dried human amniotic membrane (AD-hAM) prepared under aseptic conditions and terminally sterilized using cobalt-60 irradiation (20-25 kGy). The membrane is applied as a biological graft for regenerative clinical applications, including diabetic foot ulcers and corneal ulcers. All participants receive the same intervention and there is no control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with complete wound healing after application of gamma-sterilized air-dried human amniotic membrane
Time Frame: 2 months
Complete wound healing will be evaluated by clinical examination during scheduled follow-up visits after application of the gamma-sterilized air-dried human amniotic membrane graft. Healing will be defined as complete epithelialization of the wound surface with full closure of the lesion and absence of drainage, infection, or inflammatory signs. Wound dimensions will be measured using standardized clinical measurement techniques and compared with baseline measurements recorded prior to treatment. Clinical evaluation may be supported by photographic documentation to monitor the healing process over time. The primary outcome will be reported as the number of participants who achieve complete wound healing within the specified follow-up period.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean reduction in wound area (cm²)
Time Frame: Baseline and 4 weeks after treatment
Reduction in wound size will be assessed by measuring the wound surface area using standardized clinical measurement methods. Measurements will be performed at baseline before treatment and during follow-up visits. The change in wound area will be calculated by comparing baseline measurements with those obtained at the end of the follow-up period. This outcome will evaluate the effectiveness of the gamma-sterilized air-dried human amniotic membrane in promoting wound size reduction
Baseline and 4 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Libyan Center for Biotechnology Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

August 2, 2026

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LibyanCBR
  • BEC-BTRC6-2021 (Other Identifier: Bioethics Committee of LBTRC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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