NCT03312595已完成不适用
Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) A Case Series of Initial Effectiveness and Safety Measures
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 10
- 主要终点
- Percentage of Participants With Wound Closed
研究概览
简要总结
The primary objective of this study is to determine the outcomes of patients who receive a certain type of skin substitute called RestrataTM Wound Matrix (Restrata™). Results of this study may be used to make decisions on whether to conduct additional studies on this particular wound matrix product. RestrataTM has been cleared by the Food and Drug Administration for use in certain types of ulcer treatments, including the type that will be part of this study (diabetic foot ulcers).
详细描述
Control Group: None (Utilize historical / published data on outcomes using standard of care)
Test Group: Treatment of DFUs with RestrataTM Wound Matrix
Study Type: Interventional
Study Design: Allocation: Non-randomized Endpoint Classification: Efficacy Intervention Model: Direct assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female age 18 or older
- •Patient's ulcer must be diabetic in origin, located at least in part on the plantar surface and larger than 1cm2 after the run-in period. Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement
- •Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
- •Ulcer must be present for a minimum of four weeks before enrollment/randomization, with documented failure of prior treatment to heal the wound. A two-week run in period will precede enrollment/randomization in the trial to document the indolent nature of the patients selected
- •Patient does not exhibit clinical signs / symptoms of infection upon gross observation (at least 3 of the following: pain, redness, purulence, exudate, temperature) or have been diagnosed with an active infection at time of screening
- •Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study
- •Patient has adequate control of diabetes, as demonstrated by one of the following within 30 days of screening:
- •HbA1c < 12%
- •Serum Creatinine < 3.0mg/dl
- •Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days of the first screening visit:
- •Dorsum transcutaneous oxygen test (TcPO2) with results
- •≥30mmHg, OR
- •ABIs with results of ≥0.7 and ≤1.5, OR
- •Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg
排除标准
- •Patients presenting with an ulcer probing to bone (UT Grade IIIA-D)
- •Patients whose index diabetic foot ulcers are greater than 25cm2
- •Patient has an additional wound within 3cm of the study wound
- •Patients not in reasonable metabolic control
- •Patients with a known history of poor compliance with medical treatments
- •Patients who have been previously enrolled into this study, or are presently participating in a clinical trial with DFU indications
- •Patients with known or suspected local skin malignancy to the index diabetic ulcer
- •Patients diagnosed with autoimmune connective tissues diseases
- •Patients that have received a graft material on the study ulcer within the previous 30 days
- •Patients who are pregnant or breast feeding
- •Patients who are taking medications that are considered immune system modulator
- •Study wound has closed > 30% over the two-week run-in period
- •Patients with a known allergy to resorbable suture materials
结局指标
主要结局
Percentage of Participants With Wound Closed
时间窗: Up to 14 weeks
from baseline at week 0 to 14 weeks
次要结局
- Change in Wound Area From Baseline(Baseline and weekly for up to 14 weeks)
- Time to Wound Closure(Baseline up to 14 weeks)
研究者
研究点 (10)
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