A Comparative Evaluation of a Marine Polysaccharide (MPS) Dressing and a Carboxymethylcellulose (CMC) Dressing on Subjects With Lower Extremity Venous Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 62
- 试验地点
- 10
- 主要终点
- Percent Change in Wound Size From Baseline
研究概览
简要总结
Venous leg ulcers are lower extremity ulcers that develop due to sustained venous hypertension resulting from chronic venous insufficiency. Varicose veins, deep vein thrombosis, poor calf muscle function, arterio-venous fistulae, obesity and history of leg fracture are some of the risk factors for venous ulceration. Numerous dressing types exist to treat these ulcers. This study will compare a marine polysaccharide (MPS) dressing to a carboxymethylcellulose dressing to determine which dressing better manages these wounds with regard to wound size and periwound skin condition. Subjects will be randomized to receive either MPS-Ag dressing or CMC-Ag dressing.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able and willing to comply with requirements of this trial protocol
- •Voluntarily signed informed consent before any trial related procedures are performed
- •Subjects must be able to communicate effectively with study personnel
- •Subject has lower extremity venous ulcer wound, as determined by site PI.
- •Subject has adequate circulation as determined by biphasic or triphasic Doppler waveform, consistent with adequate blood flow, within three months prior to study enrollment. If monophasic on exam, then non-invasive tests must display Ankle Brachial Index over 0.8 and no worse than mild disease on segmental pressures.
- •Subjects should not be allergic to silver (Ag).
- •Size of subject's wound is between 1 squared centimeter and 100 squared centimeters.
- •Duration of subject's wound is less than 52 weeks.
排除标准
- •Subjects who are pregnant, nursing, or planning to become pregnant during the course of the study.
- •Subjects who have known allergies to any ingredient(s) in the clinical products used in this study.
- •Subjects who do not wish to use products derived from shellfish.
- •Subjects with substance use disorder.
- •Subjects with active infection or currently receiving antibiotic treatment.
- •Subjects who are currently enrolled in another research study which includes investigational treatment and/or medication.
- •Subjects judged by the investigator or sub-investigator to be inappropriate as a subject of this study.
- •Subject has previous or current systemic disease(s) which, in the judgement of the site PI, is likely to interfere with the study. However, subjects with well-controlled diabetes mellitus (HbA1C < 8.5) shall be permitted.
结局指标
主要结局
Percent Change in Wound Size From Baseline
时间窗: Baseline to 56 days
Evaluate and compare the percent change in wound size from first to last visit; therefore, percentage change in wound area (mean (t-test) and median (Mann-Whitney U-test)) from first to last visit was calculated for comparison
次要结局
- Score on a Pain Scale.(Baseline to 56 days)
- Evaluation of Peri-ulcer Skin Assessment Scale(Baseline to 56 days)
- Change in Surface Area of the Dressing(Baseline to 56 days)