An interventional study of Liposuction and Standard wound care in Leg Ulcer, sponsored by Odense University Hospital. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-08.
Sponsored by Odense University Hospital · Not applicable, Interventional, and Treatment
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.
298 studies on the registry are indexed under Leg Ulcer; 43 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 241 interventional studies indexed under Leg Ulcer.
Browse Leg Ulcer studies →Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
local injection around and under wound with autologous stromal vascular fraction. Standard wound care is given independent of this study.
Procedure: Liposuction · Other: Standard wound care · Drug: Adipose-Derived Regenerative Cells
Standard wound care is given independent of this study.
Other: Standard wound care
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.
Change 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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Odense University Hospital