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

NCT07466576 | Not Yet Recruiting Phase 1 DMC

• 2 other identifiers: LibyanCBRBEC-BTRC6-2021
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetic Foot Ulcer (DFU)

Outcome Measures

Primary Outcomes (1)

• 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.

  2 months

Secondary Outcomes (1)

• Mean reduction in wound area (cm²)

  Baseline and 4 weeks after treatment

Study Arms (1)

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

Biological: Air-Dried Human Amniotic Membrane (AD-hAM)

Interventions

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.

Air-Dried Human Amniotic Membrane

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients requiring ocular surface reconstruction due to chemical/thermal burns, persistent epithelial defects, or conjunctival defects.
• \. Patients with chronic non-healing diabetic foot ulcers (DFU) of at least 4 weeks duration.
• \. Ability to understand the study procedures and provide written informed consent.
• \. For tissue donors (placenta): healthy mothers undergoing elective cesarean delivery with negative infectious disease screening (HIV, HBV, HCV, syphilis).

You may not qualify if:

• 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

Sponsors & Collaborators

• Libyan Center for Biotechnology Research: lead

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Central Study Contacts

Fawzi Ebrahim Ebrahim, PhD

CONTACT

00218 916423664; fowzi.omar@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Outcomes assessors will be blinded to the assigned gamma irradiation dose group (25 kGy). The amniotic membrane grafts will be labeled using coded identifiers to conceal the sterilization dose during clinical evaluation. Due to the nature of the intervention, treating clinicians will not be blinded. Participants will not be informed of the assigned irradiation dose.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cell and Tissue Culture Department

Model Details: 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

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 12, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 2, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03