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

NCT07466576 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2026-06-29

No results posted yet for this study

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)
  • Ocular Disorder
  • Pterygium

Interventions

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.

Sponsors & Collaborators

  • Libyan Center for Biotechnology Research

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-02-10
Completion
2026-07-01

Countries

  • Libya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07466576 on ClinicalTrials.gov