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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01932021
Recruitment Status : Unknown
Verified April 2014 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : August 30, 2013
Last Update Posted : April 9, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Tracking Information
First Submitted Date  ICMJE April 18, 2013
First Posted Date  ICMJE August 30, 2013
Last Update Posted Date April 9, 2014
Study Start Date  ICMJE April 2013
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2013)
Treatment of hypertensive leg ulcer by adipose tissue grafting [ Time Frame: one year ]
The objective of this study is to evaluate pain
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2013)
treatment of angiodermatitis necrotitis by lipofilling [ Time Frame: one year ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Hypertensive Leg Ulcer by Adipose Tissue Grafting
Official Title  ICMJE Treatment of Hypertensive Leg Ulcer by Adipose Tissue Grafting
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).

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Skin Ulcer
Intervention  ICMJE Procedure: adipose tissue grafting
Study Arms  ICMJE Experimental: adipose tissue grafting
Intervention: Procedure: adipose tissue grafting
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 27, 2013)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01932021
Other Study ID Numbers  ICMJE 2012-A01613-40
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Caen
Study Sponsor  ICMJE University Hospital, Caen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anne Dompmartin, MD University Hospital, Caen
PRS Account University Hospital, Caen
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP