NCT04918784已完成不适用
Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Number of Participants With 100% Re-epithelialization
研究概览
简要总结
The purpose of the following prospective, randomized, controlled clinical trial is to compare synthetic hybrid-scale fiber matrix (Restrata®, Acera Surgical, Inc.) with standard of care in treating diabetic foot ulcers in human subjects.
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 (Participant)
盲法说明
The patient will remain blinded to the randomization assignment from the time of randomization assignment to the end of the treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is at least 18 years old
- •Patient is willing and capable of complying with all protocol requirements
- •Patient or legally authorized representative (LAR) is willing to provide written informed consent prior to or at the beginning of the run-in period
- •Patient has Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per American Diabetes Association)
- •Ulcer must be located at least in part on the foot or ankle
- •Ulcer must be present for a minimum of 28 days prior to randomization and initial application of study product
- •Wound size must be < 30cm2 on the day of randomization and initial application of the study product, after initial debridement
- •Patient has adequate circulation to the affected extremity, as demonstrated by at least ONE of the following within 60 days prior to enrollment/randomization:
- •Dorsum transcutaneous oxygen test (TcPO2) of study leg with results ≥40mmHg, OR
- •Ankle-Brachial Index (ABI) of study leg with results of ≥ 0.7
- •Toe-Brachial Index (TBI) of study extremity with results of > 50 mmHg
排除标准
- •Patient has been previously enrolled into this study, or is currently participating in another drug or device study that has not reached its primary endpoint
- •Patient is pregnant, breast feeding or planning to become pregnant
- •Patient has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
- •Patient has a life expectancy less than six months as assessed by the investigator
- •Patient has received skin substitutes during the run-in period or within 14 days prior to beginning of run-in period
- •Patient has an additional wound within 3 cm of the study wound
- •Hgb A1c > 12% within 3 months prior to randomization in patients with a known history of diabetes
- •Patient not in reasonable metabolic control in the judgment of the investigator
- •Patient with a known history of poor compliance with medical treatments
- •Patient currently undergoing cancer treatment
- •Patient has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis
- •Patient is taking parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during the run-in period or up to 30 days before the run-in period. Chronic oral steroid use is not excluded if dose is < 10 mg per day for prednisone.
- •Active infection, undrained abscess, or critical colonization of the wound with bacteria in the judgment of the investigator
- •Osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence
- •Patient unwilling to or unable to safely utilize appropriate offloading device to unweight wound
- •Study ulcer spontaneously closes during the 2-week run in period
结局指标
主要结局
Number of Participants With 100% Re-epithelialization
时间窗: 12 weeks
Primary outcome is number of participants with 100% epithelialization at 12 weeks of treatment as determined by investigator assessment of the ulcer and imaging.
次要结局
- Time to Wound Closure(Up to 12 Weeks)
- Change in Wound Area(12 weeks)
- Number of Treatment Applications(12 weeks)
研究者
研究点 (2)
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