Treatment of Hypertensive Leg Ulcer by Adipose Tissue Grafting (Angiolipo)
Recruitment status was: Recruiting
The hypertensive leg ulcer is a very painful leg related to acute skin microangiopathy. It occurs in patients older than 60 years followed for hypertension. Clinical diagnosis requires eliminating other causes arterial ulcers, cryoglobulinemia, thrombophilia, cholesterol crystal emboli, vasculitis associated with hepatitis C, myeloproliferative disorders and ulcers associated with the Hydrea ® outlet.
There is no treatment of the ulcer because conventional treatments are ineffective. The pain has subsided by analgesics III. Other treatments are not effective outside skin grafts to be repeated because they necrotic regularly. In a prospective uncontrolled study, 11 patients healed through autohemotherapy.
Ineffective treatment of this painful condition and efficiency of these cells to the damaged tissue, due to the secretion of many bioactive molecules, led us to propose subcutaneous injections of autologous fat to change the wound bed, promote healing and eliminate pain. This treatment should help to avoid long-term hospitalization (about 15 days) that can lead to physical and psychological degradation of these elderly patients.
The investigators propose an open clinical study of 10 patients with a single-center recruitment (CHU Caen). The study took place over a period of 18 months with a 12-month recruitment and follow-up of 6 months for each patient.
The purpose of this study was to evaluate the one hand, tolerance, in terms of pain and side effects, and, on the other hand, the effectiveness of this therapeutic approach, in terms of healing of the ulcer assuming a decrease in the size of the estimated at least 40% at 3 months wound. The measure of effectiveness will also focus on the changing appearance of the wound, including the relative areas of fibrin, necrosis and budding. These efficiency measures (area ratio) will be done through a computer program (CANVAS ®) on photographs taken at each assessment time.
Eventually, if this study was to demonstrate the effectiveness of this treatment lipofilling, it would be possible to perform a multicenter study on a large number of patients to demonstrate the effectiveness, in terms of wound healing that the pain it causes and offer a shorter hospital stay, and in parallel, this approach should improve the pathophysiology of ulceration (translational research).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Hypertensive Leg Ulcer by Adipose Tissue Grafting|
- Treatment of hypertensive leg ulcer by adipose tissue grafting [ Time Frame: one year ] [ Designated as safety issue: Yes ]The objective of this study is to evaluate pain
- treatment of angiodermatitis necrotitis by lipofilling [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Other objectives are to evaluate the tolerance, in terms of pain and side effects, and secondly, the effectiveness of this therapeutic approach, in terms of healing of the ulcer assuming a decrease in the size of the estimated at least 40% at 3 months wound.
The objective also covers the measurement of changes in the appearance of the wound, with an expected decrease of relative areas of fibrin and necrosis. The percentage of wound healing and wound area was measured at each visit, a curve will be performed for each patient to assess the speed of healing and the appearance of the wound will be notified.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
|Experimental: adipose tissue grafting||Procedure: adipose tissue grafting|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01932021
|University Hospital, Caen|
|Caen, France, 14 000|
|Principal Investigator:||Anne Dompmartin, MD||University Hospital, Caen|