A Randomized, Outcome Assessor-Blinded Clinical Trial Comparing the Efficacy of Acellular Dermal Matrix (ADM) Hydrogel Versus Alginate Dressings in the Treatment of Chronic Traumatic Wounds
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Wound surface area (cm²) at Week 12, adjusted for baseline wound size
研究概览
简要总结
The goal of this clinical trial is to find out whether a wound treatment made from acellular dermal matrix (ADM) gel can help heal chronic traumatic wounds more effectively than standard alginate dressings in adults aged 18 and older with wounds that have lasted more than 3 weeks.
The main questions it aims to answer are:
Does ADM gel reduce the size of chronic wounds more than alginate dressings after 12 weeks?
Does ADM gel help wounds heal faster and improve quality of life for patients?
Researchers will compare ADM gel to alginate dressings to see if the ADM gel leads to better healing results and fewer complications.
Participants will:
Be randomly assigned to receive either ADM gel or alginate dressing.
Have the treatment applied directly to their cleaned wound.
Attend weekly visits for up to 12 weeks for wound checks, measurements, and dressing changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
In addition to outcome assessors, the data analyst is blinded to the randomization
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
- •Chronic trauma wounds persisting ≥3 weeks.
- •Wound size between 4 and 20 cm² and depth ≤9 mm on the lower limbs.
- •Willingness and ability to provide informed consent.
- •Wounds without uncontrolled infection
排除标准
- •Wounds with exposed bone.
- •Current use of immunomodulators, corticosteroids, immunosuppressive or cytotoxic drugs.
- •Pregnant individuals.
- •Significant reduction (≥30%) of wound size during a 2-week run-in phase.
- •Concurrent participation in another clinical trial involving drugs.
- •Wounds with uncontrolled infection
- •Allergy or hypersensitivity to components of ADM gel or alginate
结局指标
主要结局
Wound surface area (cm²) at Week 12, adjusted for baseline wound size
时间窗: Week 1 and 12
Wound surface area is measured as length × width (in cm²) using digital planimetry. Comparison of wound size between groups at Week 12 will be conducted using ANCOVA, adjusting for baseline wound size and relevant covariates.
次要结局
- Time to complete wound healing (100% epithelialization)(Weekly up to 12 weeks)
- Rate of granulation tissue formation(Weekly up to 12 weeks)
- Rate of wound epithelialization(Weekly up to 12 weeks)
- Incidence of complications (infection, necrosis, bleeding)(Up to 12 weeks)
- Quality of life score at Week 12(Weeks 1 and 12)
研究者
Fateme Abedini
Principal Investigator
Isfahan University of Medical Sciences