The RENEW Study: (Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds): A Non-Inferiority Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Primary Endpoint
研究概览
简要总结
This is an IRB-approved multicenter study.This non-inferiority study aims to evaluate differential healing rates between Lavior Diabetic Wound Gel and other Hydrogels. Study therapy will be started in the outpatient setting and followed accordingly.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The Study Participant, The Care Provider, and the Investigator are all blinded from the treatments.
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
- •Foot Wound in the setting of Diabetes Mellitus
- •Written informed consent
- •Minimum wound surface area of 0.7 x 0.7 cm (0.49 square cm)
排除标准
- •Age < 18 years
- •Noncompliance with study procedures, visit schedule or follow up Gangrene and/or untreatable Peripheral Arterial Disease
- •Malignancy of the wound
- •Use of any other hydrogels not being studied in this investigation within 1 month of being enrolled
- •Dry, uninfected, stable pressure ulcers of the heel
- •Dry, stable eschar in arterial wounds
- •Simultaneous participation in competing clinical trials
- •Pregnancy or Nursing mothers
研究组 & 干预措施
CONTROL THERAPY
Control therapy is defined as Smith & Nephew Solosite Gel Hydrogel Wound Dressing, according to actual guidelines or local clinical standards. Standard therapy is defined as the currently accepted and widely used treatment for the respective wound type, based on the results of past research. Therapy options for standard wound care are treatments that experts agree to be appropriate, accepted, and widely used.
干预措施: Smith & Nephew Solosite Gel Hydrogel Wound Dressing (Drug)
TRIAL INTERVENTION
Trial intervention is wound treatment with Lavior Diabetic Wound Gel.
干预措施: Lavior Diabetic Wound Gel (Drug)
结局指标
主要结局
Primary Endpoint
时间窗: 60 days
The primary endpoint of this trial is defined as time (number of days) to achieve complete wound closure in study participants where closure was observed on or before Day 60. The primary endpoint of this trial is defined as time (number of days) to achieve complete wound closure in study participants where closure was observed on or before Day 60.
次要结局
- Change in wound depth over time (cm)(60 Days)
- Change in wound surface area over time (cm)(60 Days)
- Change of wound size over time (cm)(60 days)
- Change in Pain Scores over time (60 days)(60 days)
- Incidence of wound closures within 60 days(60 days)
- Recurrence(60 days)