A Randomized, Placebo-controlled, Double-blind Phase II Study to Evaluate the Efficacy of IZN-6D4 Gel for the Treatment of Diabetic Foot Ulcers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- The percent reduction in wound area at week 4 compared to the baseline visit
研究概览
简要总结
The purpose of this study is to determine if topical application of a hydrogel that contains plant extracts will improve healing of diabetic foot ulcers when compared to treatment with a hydrogel alone.
详细描述
This is a multi center, double-blind, randomized, placebo-controlled trial. A total of 80 patients will be randomized according to a 1: 1 randomization schedule. To participate in the trial, patients must have a current Diabetic Foot Ulcer (DFU) for between 60 days to 2 years at the screening visit. In the 2-week period between screening and baseline visit, the patient's DFU must not have healed by 30% or more, in wound area, while being treated with SWT twice a week during this screening period.
During the treatment period of 4 weeks all patients will be examined on a weekly basis by the site staff. Treatment with SWT plus the study gel (IZN-6D4 Gel or placebo gel) (including any necessary debridement) will be administered at these weekly visits. In addition, the patient or caregiver will be trained to perform SWT plus the study treatment at home once midweek between visits.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Current diagnosis of diabetes mellitus type 1 or 2
- •Foot ulcer Wagner grade 1 or 2
- •Ulcer between 1 square cm and 8 square cm present for at least 60 days and not more than two years
- •HgbA1C less than 10%
- •Able to comply with all procedures
排除标准
- •Wound area decrease of greater than 30% between screening and baseline visits
- •Gangrene on any part of the affected foot
- •Pregnancy or lactation
研究组 & 干预措施
IZN-6D4 Gel
patients in this arm will be treated by twice a week bandaging the wound with active IZN-6D4 Gel
干预措施: IZN-6D4 Gel (Drug)
Placebo Hydrogel
patients in this arm will be treated by twice a week bandaging the wound with a hydrogel used for wound care, but without the active IZN-6D4
干预措施: Placebo hydrogel (Other)
结局指标
主要结局
The percent reduction in wound area at week 4 compared to the baseline visit
时间窗: Weekly measurements of wound area from study initiation and through week 4
次要结局
- The percent conversion of the wound bed to granulation tissue by week 4 compared to baseline(Weekly assessments from baseline through week 4)
- The percentage of lesions that demonstrate at least 40% reduction in area by the end of week 4 compared to baseline visit(Weekly assessments of wound area through week 4)
- The percentage of lesions that demonstrate at least 50% reduction in area by the end of week 4 compared to baseline visit(Weekly assessments of wound area from baseline through week 4)