NCT02987101

Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leg Ulcer

Interventions

Type	Name	Description
PROCEDURE	Liposuction	Adipose tissue is harvested by liposuction from either abdomen or thighs.
OTHER	Standard wound care	Patients will receive standard wound care and dressings independent of their participation in this study at the discretion of the wound nurses.
DRUG	Adipose-Derived Regenerative Cells	Cells isolated from adipose-derived tissue will be injected locally around and under the wound.

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2016-12-08
• Last updated: 2016-12-08

Locations

1 site across 1 country: Denmark