Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers (MAUV)
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|ClinicalTrials.gov Identifier: NCT00820274|
Recruitment Status : Terminated (clinical trial have encountered difficulties enrolling a sufficient number of patients)
First Posted : January 12, 2009
Last Update Posted : September 1, 2015
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
|Condition or disease||Intervention/treatment||Phase|
|Resistant Vascular Ulcers||Procedure: amniotic membranes||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||June 2016|
|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
- Measure of the diameter of the ulcer [ Time Frame: Every week ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|