THE EFFECT OF AMNION ON WOUND HEALING IN CHRONIC WOUNDS - A SINGLE CENTRE INTERVENTIONAL STUDY
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Wound closure rates
研究概览
简要总结
Brief Summary of the StudyChronic wounds, such as diabetic foot ulcers, venous ulcers, and pressure ulcers, present significant healthcare challenges due to their resistance to standard treatments and associated complications like infections, necrosis, and amputations. Current management strategies often focus on symptom control rather than addressing underlying biological deficiencies.
Amnion, derived from the innermost layer of the placenta, has gained attention as a potential therapeutic agent for enhancing wound healing. Rich in growth factors, extracellular matrix components, and cytokines, amnion exhibits anti-inflammatory, pro-regenerative, and immunomodulatory properties. Its use has shown promising results in preliminary studies, but there remains a need for robust evidence to establish its efficacy and safety in chronic wound management.
This single-center prospective interventional study aims to evaluate the healing effects of processed human amnion applied as a dressing in patients with chronic non-healing wounds. Conducted at MS Ramaiah Hospitals, Bengaluru, the study will recruit 64 participants who meet specific inclusion criteria, such as chronic wounds persisting for at least four weeks despite standard care. Participants will receive amnion dressings, and outcomes will be assessed over a specified follow-up period.
Primary outcomes include wound closure rates, while secondary outcomes focus on pain reduction, improvements in quality of life, and cost-effectiveness. Data will be analyzed using paired t-tests to assess the efficacy of amnion therapy.
The study’s findings aim to provide valuable insights into the role of amnion in wound healing, contributing to the advancement of wound care practices and scientific understanding of tissue regeneration. This research could potentially establish amnion-based therapies as a standard of care for managing chronic wounds, improving patient outcomes and reducing healthcare burdens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with chronic wounds, such as diabetic foot ulcers, venous ulcers, pressure ulcers, or other non-healing wounds persisting for at least four weeks despite standard wound care.
- •Wounds located on anatomical sites amenable to the application of amnion Patients with chronic wounds without clinical signs of infection or systemic infection at the time of enrolment Patients with a history of standard wound care treatments, including debridement, offloading, and appropriate wound dressings, but no recent use of advanced wound therapies such as growth factors or cellular therapies Patients with stable medical conditions and no acute systemic illnesses that may interfere with wound healing or study participation.
排除标准
- •Patients with Acute Wounds / Acute Infections Patients with Terminal illnesses / Non-compliant patients Patients with a history of Prior Radiation Therapy Pregnant Patients / Immunocompromised patients Patients with arterial insufficiency as confirmed by ABI & TCPO2 Patients with Uncontrolled Diabetes.
结局指标
主要结局
Wound closure rates
时间窗: 6-8 weeks
次要结局
- Pain reduction(Improvements to quality of life)
研究者
Mohit Naren Kondapalli
MS RAMAIAH MEDICAL COLLEGE & HOSPITAL