Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction

Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction

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.

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