Clinical Trial: Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction

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 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 (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.


Sponsor: Odense University Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Distal blood pressure measurement [ Time Frame: 6 months ]
    Change in distal blood pressure measurement before and 6 months after treatment
  • Transcutaneous oxygen tension [ Time Frame: 6 months ]
    Change in transcutaneous oxygen tension around the wound before and 6 months after treatment.
  • Treatment-related adverse events [ Time Frame: 6 months ]
    Monitoring of any side effects or complications related to intervention


Original Secondary Outcome: Same as current

Information By: Odense University Hospital

Dates:
Date Received: November 24, 2016
Date Started: November 2016
Date Completion: June 2018
Last Updated: December 6, 2016
Last Verified: December 2016