Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers (MAUV)
To evaluate tolerance and efficiency of cryopreserved amniotic membranes in local treatment of resistant vascular ulcers.
To evaluate complete cicatrisation, efficiency on pain, prevention of infection, improvement of quality of life.
To evaluate rate of amputations and recurrence at one year after complete cicatrisation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers|
- Measure of the diameter of the ulcer [ Time Frame: Every week ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||June 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Experimental: amniotic membranes||
Procedure: amniotic membranes
The amniotic membrane is taken with a sterile crowbar then applied side foetal face against the ulcer and displayed in a homogeneous way
Treatment of patients suffering from vascular ulcers or amputation's wound from at least 6 months after or without possibility for surgical treatment. A cryopreserved amniotic membrane, obtained after caesarean from consenting women without any disease, is applied on the ulcer after serological checking and changed once a week.
Tolerance will be evaluated on clinical criterias. Efficiency will be evaluated by measuring reduction of ulcer's area (reduction of at least 50 % at 6 months).
Reduction of pain will be evaluated by analogic visual scale and evaluation of analgesic consumption.
Evaluation of infections, amputations, complete healing, improvement of quality of life by SF36 questionnaire and recurrence at one year for patients with complete healing.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00820274
|Service de Médecine Interne et Pathologie Vasculaire|
|Bordeaux, France, 33075|
|Service de Chirurgie Vasculaire et Viscérale|
|Bordeaux, France, 33076|
|Service de Chirurgie Thoracique, cardiovasculaire et angiologie|
|Limoges, France, 87000|
|Principal Investigator:||Francis Pesteil, MD||CHU Limoges|