Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Odense University Hospital

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