A Prospective, Open, Non-controlled Clinical Investigation to Evaluate a NPWT (Negative Pressure Wound Therapy) System to be Used in the Treatment of Diabetic Foot Ulcers (DFUs) Including Post Amputation Wounds Associated With Diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Mean Change in Wound Area.
研究概览
简要总结
Primary objective
- To assess wound healing and granulation tissue formation when using the NPWT system
Secondary objectives
- To investigate the pain level at dressing removal
- To visually check exudate removal
- To investigate the ease of use for the subject and care giver when using the NPWT system
详细描述
The investigation is designed as a prospective, open, non-controlled clinical investigation.
Wounds to be treated under this protocol should be Diabetic foot ulcers (DFUs) or post amputation wounds associated with diabetes in hospitalized subjects or subjects treated at home. One ulcer or post amputation wound per subject will be treated for a maximum duration of 4 weeks. All subjects will receive negative pressure treatment with the NPWT system, -120 mm Hg.
In total, 10-15 subjects at two sites will be enrolled provided that they fulfill all the inclusion criteria and none of the exclusion criteria and have signed and dated a written informed consent.
The subjects will be consecutively allocated to a specific subject identification code and the recruitment will be competitive.
The primary variable wound healing and granulation tissue formation will be assessed by digital planimeter, digital photography and visual estimation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diabetic foot ulcers (DFUs) including post amputation wounds associated with diabetes suitable for Negative Pressure Wound Therapy according to the investigator's judgment
- •1 cm2 ≤ Wound size ≤ 200 cm2
- •Male or female, 18 years and above
- •Signed Informed Consent Form
- •Subject understands the written subject Information
排除标准
- •Need for frequent dressing changes, i.e.<72 hours between the changes
- •Critical ischemia (for wound healing) according to investigator's judgement
- •Malignancy in the wound and/or wound margin
- •Target ulcer previous not successfully treated with NPWT within 48 hours
- •Poorly controlled diabetes according to investigators judgement.
- •Osteomyelitis which has been left untreated
- •Infection which has been left untreated
- •Unexplored fistula
- •> 10% surface area necrotic tissue with eschar present after debridement
- •High risk for bleeding complications
- •Exposed major blood vessels, organs or nerves
- •Current or within 3 months treatment with chemotherapy or irradiation
- •Known hypersensitivity to the dressing material
- •Expected technically impossible to seal the film to maintain a vacuum for treatment
- •Expected non compliance with the Clinical Investigation Plan
- •Subjects not suitable for the investigation according to the investigator's judgement
- •Subjects previously included in this investigation
- •Subjects included in other ongoing clinical investigation at present or during the past 30 days
结局指标
主要结局
Mean Change in Wound Area.
时间窗: From baseline to maximum 4 weeks
Measured by tracing of wound and measured by planimeter.
次要结局
未报告次要终点