Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings for the Management of Patients With Venous Stasis Ulcers.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Rate of healing
研究概览
简要总结
This study is being conducted to determine how the PICO™ Negative Pressure Wound Therapy compares to standard care treatment for venous stasis ulcers, as there is no evidence to date.
详细描述
This is a single-blind, randomized pilot study conducted in patients with bilateral venous stasis leg ulcers.
The aim of the study is to compare the rate of healing for venous stasis ulcers when using the PICO™ single use Negative pressure wound therapy (NPWT) system versus standard care.
The primary objective is to determine if the PICO™ NPWT system results in an increased rate of healing when compared to standard of care for the treatment of venous stasis ulcers.
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
- Double (Participant, Care Provider)
盲法说明
Subjects and treating physician will be blinded to treatment.
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
- •Patient with bilateral venous leg ulcers (one on each lower extremity) (defined as any break in the skin that has either been present for longer than 6 wks or occurred in a person with a history of venous leg ulceration).
- •The ulcer is required to be venous in appearance (ie: moist, shallow, and of an irregular shape), and judged unlikely to heal within 21 days.
- •18 years old or older
- •Have an ankle brachial pressure index of at least 0.8 that was measured within the previous 3 months.
排除标准
- •• Patients on anticoagulants- (ie: warfarin, direct thrombin inhibitors).
- •Patients who have a pressure index measured within the previous 3 months to be greater than 1.20
- •Patients with venous stasis ulcers greater than 17cm by 17cm.
- •Gross leg edema
- •Severe wound exudate
- •Patients with malignancy in the wound bed or margins of the wound
- •Previously confirmed and untreated osteomyelitis.
- •Patients with necrotic tissue with eschar present.
- •Patients with wounds that involve exposed arteries, veins, nerves, bone fragments or sharp edges.
- •Patients with wounds that requires surgical suction.
研究组 & 干预措施
Negative Pressure Wound Therapy
Subjects will have one venous stasis ulcer treated with the PICO Negative Pressure Wound Therapy Device
干预措施: PICO Negative Pressure Wound Therapy (Device)
Compression Dressing- Standard of Care
Subjects will have one venous stasis ulcer treated with the standard of care compression dressing.
干预措施: Compression Dressing (Procedure)
结局指标
主要结局
Rate of healing
时间窗: Weekly for three weeks
Surface area and depth of wound measurements will be collected to determine rate of healing
次要结局
未报告次要终点