Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction
Overview
- Phase
- Not Applicable
- Intervention
- Liposuction
- Conditions
- Leg Ulcer
- Sponsor
- Odense University Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in wound size
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Navid Toyserkani
Resident, PhD fellow, MD
Odense University Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Uncontrolled wound infection
- •Osteomyelitis
- •Hemoglobin \<6.0mmol/L
- •HbA1c \>80mmol/mol
- •Underlying malignancy
- •Pregnancy or lactating
- •Renal insufficiency requiring dialysis
- •Charcot foot
- •Underlying malignancy
Arms & Interventions
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.
Intervention: Liposuction
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.
Intervention: Standard wound care
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.
Intervention: Adipose-Derived Regenerative Cells
Standard of care
Standard wound care is given independent of this study.
Intervention: Standard wound care
Outcomes
Primary Outcomes
Change in wound size
Time Frame: 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.
Secondary Outcomes
- Distal blood pressure measurement(6 months)
- Transcutaneous oxygen tension(6 months)
- Treatment-related adverse events(6 months)