Treatment of Hypertensive Leg Ulcer by Adipose Tissue Grafting

NCT01932021 | Unknown DMC

• 1 other identifier: 2012-A01613-40
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Skin Ulcer

Keywords

necrotitis angiodermatitis; autologous fat transplantation; mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

• Treatment of hypertensive leg ulcer by adipose tissue grafting

  The objective of this study is to evaluate pain

  one year

Secondary Outcomes (1)

• treatment of angiodermatitis necrotitis by lipofilling

  one year

Study Arms (1)

adipose tissue grafting

EXPERIMENTAL

Procedure: adipose tissue grafting

Interventions

adipose tissue grafting PROCEDURE

adipose tissue grafting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years with a necrotic ulcer or angiodermatitis Martorell.
• Recipient of the system of social security.
• Ulceration sudden onset peripheral Livedoid border, on superficial leg without bone or tendon exposure.
• IPS Index (systolic pressure)\> 0.8 with pedal pulses.
• Wound area less than 300 cm2 surface measurement with Canvas ® software from a photograph of the wound next to which there is a calibration strip.
• Patients with hypertension.
• Patient was informed of the study and having signed an informed consent.

You may not qualify if:

• Severe distal arteritis (arteritis of large arteries).
• Histological vasculitis.
• Collagen (THE BY, scleroderma).
• Blood Pathology: Cryoglobulinemia, Polycythemia.
• Hepatitis A, B and C, HIV and syphilis infection
• Thrombophilia (search for markers during the initial assessment in patients with a history of phlebitis or miscarriage).
• Hyperthyroidism.
• Patient treated with Hydrea (favoring the occurrence of ulcers).
• Patient participating in another study to treat the wound concerned.
• Topics minors, pregnant women, persons deprived of liberty, adults under legal protection unable to consent.

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

University Hospital, Caen

Caen, 14 000, France

RECRUITING

MeSH Terms

Conditions

Skin Ulcer

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Anne Dompmartin, MD

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Dompmartin-Blanchère

CONTACT

+33 2 31 27 25 09; dompmartin-a@chu-caen.fr

Marianne Chopinaud

CONTACT

+33 6 85 82 29 42; mariannechopinaud@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: August 30, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 9, 2014

Record last verified: 2014-04

Locations

FR (1)