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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of participants with complete wound healing after application of gamma-sterilized air-dried human amniotic membrane
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
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
干预措施: Air-Dried Human Amniotic Membrane (AD-hAM) (Biological)
结局指标
主要结局
Number of participants with complete wound healing after application of gamma-sterilized air-dried human amniotic membrane
时间窗: 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.
次要结局
- Mean reduction in wound area (cm²)(Baseline and 4 weeks after treatment)
研究者
Fawzi Ebrahim. PhD
Head of Cell and Tissue Culture Department
Libyan Center for Biotechnology Research