Treatment of Hypertensive Leg Ulcer by Adipose Tissue Grafting (Angiolipo)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital, Caen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01932021
First received: April 18, 2013
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention
Skin Ulcer
Procedure: adipose tissue grafting

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 10
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)
Arms Assigned Interventions
Experimental: adipose tissue grafting Procedure: adipose tissue grafting

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01932021

Contacts
Contact: Anne Dompmartin-Blanchère +33 2 31 27 25 09 dompmartin-a@chu-caen.fr
Contact: Marianne Chopinaud +33 6 85 82 29 42 mariannechopinaud@hotmail.com

Locations
France
University Hospital, Caen Recruiting
Caen, France, 14 000
Contact: Anne Dompmartin    +33 2 31 27 25 09    dompmartin-a@chu-caen.fr   
Contact: Marianne Chopinaud    +33 6 85 82 29 42    mariannechopinaud@hotmail.com   
Principal Investigator: Anne Dompmartin, MD         
Sponsors and Collaborators
University Hospital, Caen
Investigators
Principal Investigator: Anne Dompmartin, MD University Hospital, Caen
  More Information

No publications provided

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01932021     History of Changes
Other Study ID Numbers: 2012-A01613-40
Study First Received: April 18, 2013
Last Updated: April 8, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Caen:
necrotitis angiodermatitis
autologous fat transplantation
mesenchymal stem cells

Additional relevant MeSH terms:
Ulcer
Skin Ulcer
Pathologic Processes
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014