A Pilot Study of Fuzzy Wale Compression Stockinet to Evaluate Healing Following Transtibial Amputation for Peripheral Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Surgical site infection
研究概览
简要总结
The objective of this study is to determine if using Fuzzy Wale compression stockinet can assist in reducing the healing time and decrease costs in transtibial amputation patients as compared to standard of care treatment compression stocking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •>18 years
- •Male and female
- •Transtibial amputation expected.
- •Peripheral arterial disease and Transcutaneous partial pressure of oxygen (TCP02, if performed)
- •Ability of subject to give appropriate consent or have an appropriate representative available to do so.
排除标准
- •Known allergies to any of the components of the compression.
- •Terminal illness or current cancer therapy with chemotherapy
- •Inability to undergo ongoing care in Rochester.
- •Lack of cognitive ability to follow instructions or monitor residual limb.
- •Vulnerable study population
- •Pregnancy
研究组 & 干预措施
Fuzzy Wale Compression Stockinet
Subjects with peripheral arterial disease requiring transtibial amputation will have Fuzzy Wale Compression Stockinet applied and utilized for 4-8 weeks post operatively or until prosthetic fitting and wound has achieved full durable healing.
干预措施: Fuzzy Wale Compression Stockinet (Device)
Standard of care
Subjects with peripheral arterial disease requiring transtibial amputation will receive standard of care treatment compression stockinet.
结局指标
主要结局
Surgical site infection
时间窗: 8 weeks post-operatively
Number of subject presenting with surgical site infections following transtibial amputation.
Wound dehiscence
时间窗: 8 weeks post-operatively
Number of subject presenting with wound dehiscence following transtibial amputation.
Pain control
时间窗: 8 weeks post-operatively
Pain control during healing following transtibial amputation will be measured using the Visual Analog Scale (VAS). VAS scores range from 0-10 with 10 being the worst possible pain and 0 being no pain.
Time to prosthetic fitting
时间窗: 8 weeks post-operatively
Number of days from transtibial amputation to prosthetic fitting.
次要结局
- Length of hospital stay(8 weeks post-operatively)
研究者
Matthew M. Melin
Principal Investigator
Mayo Clinic