Skin Ulcer Clinical Trial
Official title:
Treatment of Hypertensive Leg Ulcer by Adipose Tissue Grafting
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).
The objective of this study was to evaluate the one hand, 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. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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