Characterization of AmnioExcel Plus in Two Treatment Paradigms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of Participants Who Healed
研究概览
简要总结
The Investigators plan to evaluate healing in two cohorts of patients with diabetic foot wounds (n=20) that receive optimal treatment including serial wound debridement and off-loading with a boot or postop shoe and AmnioEXCEL+. In one cohort, AmnioEXCEL+ will be applied weekly at study visits and in the second cohort, AmnioEXCEL+ will be applied maximum every 2 weeks (PRN, in the case that the wound requires debridement at a visit not intended for AE+ application, the wound will be treated as SOC). In addition, the Investigators will collect data on other potential confounding factors that could affect healing such as antibiotic, anti-fungal and anti-infective medications, tobacco, comorbidities, diabetes control, infection, perfusion, and activity. Wound healing, including wound size and adverse events will be evaluated.
详细描述
Study Procedures:
Collection of Demographic data, medical/social history Collection of medications1 Ankle Brachial Index2 Wound debridement3 (standard of care procedure) Imaging with eKare4 Hyperspectral Imaging Application of study product
- Only collect antibiotics, anti-fungal and anti-infective medications.
- ABI (with toe pressure) can be done at screening or baseline.
- Once wound is healed, wound debridement will not be done at weekly visits.
- Once wound is healed, eKare will not be done at weekly visits.
- EOS will occur on the date the subject is healed. *Screening and Visit 1 may be done on the same day.
Screening and Enrollment*:
- Review and sign the Informed Consent and HIPAA Authorization
- Review the inclusion and exclusion criteria
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants Who Healed
时间窗: 12 weeks
Number of participants whose wounds healed during the study timeframe. Reported as dichotomous yes/no.
次要结局
- Wound Volume(Baseline)
- Wound Area(Baseline)
- Tissue Oxygenation (StO2) of the Dorsal Foot(Baseline)
研究者
Larry Lavery
Professor and Director of Research
University of Texas Southwestern Medical Center