Safety and Wound Healing Efficacy of the TalidermR Wound Dressing a Poly-N-acetyl Glucosamine-derived Membrane Material in Humans With Venous Stasis Ulcers: a Pilot Study.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- wound healing
研究概览
简要总结
The study will test a new wound healing dressing called Taliderm® on leg ulcers caused by chronic venous insufficiency (CVI). Some people with CVI have poor vein circulation that causes ulcers to develop on the lower legs. This new dressing is hoped to help the ulcers heal more quickly. The study hypothesis is to determine whether the TalidermR Wound Dressing, a poly-N-acetyl glucosamine (pGlcNAc) derived membrane material expedites wound healing in humans with venous stasis ulcers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥45 years of age
- •Diagnosis venous partial thickness ulcer diagnosed within the past
- •4 weeks without recent enzymatic, autolytic or chemical treatment
- •Viable and clean wound bed with granulation tissue and ≥ 90% free of necrotic debris
- •Wound measures between 5 and 20 cm2
- •Extends through epidermis and into the dermis
排除标准
- •Full thickness ulcers extending beyond the dermis
- •Current wound, skin, or systemic infection
- •Wound bed ≤90% free of necrotic debris
- •Recent treatment with enzymatic, autolytic or chemical agents
- •History or collagen vascular disease, severe arterial disease, organ transplant, Charcot, sickle cell
- •Insufficient blood supply to ulcer (ankle-brachial index <.8 or >1.3)
- •History of radiation therapy to the site
- •Cellulitis/osteomyelitis/avascular ulcer bed
- •Currently receiving hemodialysis
- •Pregnancy
- •Currently receiving treatment with another investigational drug or device or within the past 30 days
- •Unable to comply with the study protocol
研究组 & 干预措施
0
1
Experimental Group 1 (n = 10) will receive TalidermR to the wound once during the treatment phase.
干预措施: Taliderm wound healing dressing (Other)
2
Experimental Group 2 (n = 10) will receive TalidermR to the wound every other week during the treatment phase.
干预措施: Taliderm wound healing dressing (Other)
3
Experimental Group 3 (n = 10) will receive TalidermR to the wound every three weeks during the treatment phase.
干预措施: Taliderm wound healing dressing (Other)
结局指标
主要结局
wound healing
时间窗: 20 weeks
次要结局
未报告次要终点
研究者
Teresa Kelechi
Professor
Medical University of South Carolina