Diabetic Foot Ulcer (DFU)Phase 1GAMMA-AMNCT07466576
Air-Dried Human Amniotic Membrane Terminally Sterilized by Gamma Irradiation for Multidisciplinary Clinical Application
A Phase 1 study testing Air-Dried Human Amniotic Membrane (AD-hAM) in people with Diabetic Foot Ulcer (DFU) and Ocular Disorder, run by Libyan Center for Biotechnology Research at 1 site in Libya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Foot Ulcer (DFU), Ocular Disorder, Pterygium
- What is being tested?
- Air-Dried Human Amniotic Membrane (AD-hAM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteLibya
- Study dates
- 1 Nov 2025to 1 Jul 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Active systemic infection or sepsis.
- Immunocompromised patients (HIV positive, ongoing immunosuppressive therapy).
- Pregnant or breastfeeding women.
- History of malignancy in the past 5 years.
- Known allergy or hypersensitivity to human amniotic tissue or materials used in graft preparation.
- Participation in another investigational clinical trial within 30 days prior to enrollment
- -
Trial locations and contacts
1 site in 1 country.
Libya1 site
Libyan Biotechnology Research Center (LBTRC)
Tripoli, Tripoli, 2018
About this study
Official title: 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.
Read the 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:
- 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 reconstructs.
- Conditions
- Diabetic Foot Ulcer (DFU), Ocular Disorder, Pterygium
- Being tested
- Air-Dried Human Amniotic Membrane (AD-hAM)
- Medical subject headings
- Diabetic Foot, Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air-Dried Human Amniotic Membrane (AD-hAM)Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| Air-Dried Human Amniotic Membrane | Experimental | 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 Receives: Biological: Air-Dried Human Amniotic Membrane (AD-hAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with complete wound healing after application of gamma-sterilized air-dried human amniotic membrane
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.
Measured: 2 months
Secondary outcomes (1)
Mean reduction in wound area (cm²)
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
Measured: Baseline and 4 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Nov 2025
- Primary completion10 Feb 2026
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcer (DFU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will receive air-dried human amniotic membrane sterilized using gamma irradiation at a dose of 25 kGy. The intervention will be applied in patients with diabetic foot ulcers and corneal ulcers according to the clinical protocol. Each participant will receive one membrane application during the study period and will remain under follow-up for clinical evaluation. Outcomes will be assessed to evaluate the safety and preliminary clinical effectiveness of the sterilized membrane in regenerative applications
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Libyan Center for Biotechnology Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fawzi Ebrahim. PhD, Libyan Center for Biotechnology Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466576
- Sponsor's protocol ID
- LibyanCBR
- Other IDs
- BEC-BTRC6-2021
- Acronym
- GAMMA-AM
- Status last verified
- Jun 2026
- First submitted
- 4 Mar 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No