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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Adipose tissue is harvested by liposuction from either abdomen or thighs.
Patients will receive standard wound care and dressings independent of their participation in this study at the discretion of the wound nurses.
Cells isolated from adipose-derived tissue will be injected locally around and under the wound.
Odense University Hospital
Odense, Denmark
RECRUITINGChange in wound size
Photography is taken every 2 weeks until complete wound healing. Final follow-up date regardless of complete wound healing or not is 6 months.
Time frame: 6 months
Distal blood pressure measurement
Change in distal blood pressure measurement before and 6 months after treatment
Time frame: 6 months
Transcutaneous oxygen tension
Change in transcutaneous oxygen tension around the wound before and 6 months after treatment.
Time frame: 6 months
Treatment-related adverse events
Monitoring of any side effects or complications related to intervention
Time frame: 6 months
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