Prospective, Randomized, Single-Center Study to Compare Clinical Outcomes Between Cryopreserved and Lyopreserved Stravix as an Adjunct to NPWT in the Treatment of Complex Wounds
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Complete Wound Closure
研究概览
简要总结
This study is a prospective, 2-arm parallel assignment, randomized clinical trial to compare lyopreserved vs cryopreserved Stravix as an adjunct therapy to NPWT.
详细描述
Screening
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Explain purpose and nature of the study and obtain signature on the informed consent document.
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Screen the subject against protocol inclusion and exclusion criteria, including all pertinent tests, including pregnancy test 3. Complete SF-36, EuroQol 5 dimensions (EQ-5D) and PROMIS® Baseline (may be done as same day as screening procedures or within +2 days of screening and before start of Therapy/Treatment Phase)
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Obtain general medical history and demographic information and social history
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Complete a physical examination, body weight, height, and vital signs, including measurement of resting heart rate, respiratory rate, and blood pressure while seated.
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Select target study ulcer
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Obtain complete history pertinent to DFU disease including duration of the target ulcer, previous and current treatment. Document ulcer classification.
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Perform debridement and obtain tissue collection (3 tissue and 1 bone).
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Perform standardized photography and measurement of the study wound (eKare or available camera with ruler). Assess the post-debridement ulcer area (cm2), perimeter (cm), and greatest depth (cm) using the inSight device (eKare, Fairfax, VA). These values are the baseline measurements for calculating wound closure rate at the two-week run-in visit.
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Perform hyperspectral imaging of dorsal and plantar aspects of the foot.
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Perform neuropathy assessment
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Collect all relevant concomitant medication (antibiotics, antifungals and other anti-infective therapies)
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Place Stravix (lyo or cryo per randomization schedule) and dress wound for NPWT therapy.
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Document size of Stravix used.
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Disburse subject stipend Therapy/Treatment Phase (Weekly visits +/- 4 days)
Study Visit 1-11:
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a diabetes mellitus
- •Men/women ≥21 years old
- •Post-operative foot or ankle wounds sized >4cm2 that have presented for <1 year
- •ABI ≥0.5 or toe pressures >30 mmHg
- •Wounds indicated for treatment with NPWT
排除标准
- •Active Charcot arthropy
- •Unable to use NPWT at home
- •Untreated bone or soft tissue infection
- •Is pregnant or plans to become pregnant
- •Is nursing or actively lactating
- •Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
- •Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's ability to provide informed consent, participate in the study protocol or record study materials
结局指标
主要结局
Complete Wound Closure
时间窗: 12 weeks
Number of patients who achieve wound closure (complete epithelialization with no drainage)
次要结局
- Infection(12 weeks)
- Duration of Negative Pressure Wound Therapy(12 weeks)
- Split Thickness Skin Grafting(12 weeks)
研究者
Larry Lavery
Professor and Director of Research
University of Texas Southwestern Medical Center