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 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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
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.
Time frame: 2 months
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
Time frame: Baseline and 4 weeks after treatment
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