Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in wound size
研究概览
简要总结
Chronic leg ulcers are associated with decreased quality of life and an increased mortality. In many cases these ulcers are treated conservatively and the healing time can be several months. In this open randomized clinical trial we will examine if we can accelerate wound healing when using autologous stromal vascular fraction as an adjunct to standard wound care.
详细描述
Chronic leg ulcers are associated with decreased quality of life and an increased mortality. In many cases these ulcers are treated conservatively and the healing time can be several months. In this open randomized clinical trial we will examine if we can accelerate wound healing when using autologous stromal vascular fraction (SVF) as an adjunct to standard wound care.
The plan is to include 30 patients with arterial or arteriovenous chronic leg ulcers and these are randomized in two groups of which one receives standard wound care only and the other group receives autologous stromal vascular fraction treatment in addition to standard wound care.
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
- •Arteriovenous chronic leg ulcer
- •Present beyond 4 months
- •Conservative treatment not leading to progress
- •Wound size between 2-30cm2
- •ankle-brachial index (ABI) ( 50-90% and/or toe pressure 50-70% and where ankle pressure > 60 mmHg or toe pressure > 40 mmHg
- •Written informed consent
排除标准
- •Uncontrolled wound infection
- •Osteomyelitis
- •Hemoglobin <6.0mmol/L
- •HbA1c >80mmol/mol
- •Underlying malignancy
- •Pregnancy or lactating
- •Renal insufficiency requiring dialysis
- •Charcot foot
- •Underlying malignancy
研究组 & 干预措施
Autologous SVF + Standard of care
local injection around and under wound with autologous stromal vascular fraction.
Standard wound care is given independent of this study.
干预措施: Liposuction (Procedure)
Autologous SVF + Standard of care
local injection around and under wound with autologous stromal vascular fraction.
Standard wound care is given independent of this study.
干预措施: Standard wound care (Other)
Autologous SVF + Standard of care
local injection around and under wound with autologous stromal vascular fraction.
Standard wound care is given independent of this study.
干预措施: Adipose-Derived Regenerative Cells (Drug)
Standard of care
Standard wound care is given independent of this study.
干预措施: Standard wound care (Other)
结局指标
主要结局
Change in wound size
时间窗: 6 months
Photography is taken every 2 weeks until complete wound healing. Final follow-up date regardless of complete wound healing or not is 6 months.
次要结局
- Distal blood pressure measurement(6 months)
- Transcutaneous oxygen tension(6 months)
- Treatment-related adverse events(6 months)
研究者
Navid Toyserkani
Resident, PhD fellow, MD
Odense University Hospital