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Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers (MAUV)

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. 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
Etablissement Français du Sang
Information provided by (Responsible Party):
University Hospital, Limoges

Brief Summary:

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

Detailed Description:

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.

Main criterias:

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).

Secondary criterias:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Measure of the diameter of the ulcer [ Time Frame: Every week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Obtained informed consent
  • Leg or foot arterial or mixed ulcer older than at least 3 months

Exclusion Criteria:

  • No obtained informed consent
  • Possibility for surgical treatment (revascularisation)
  • Age less than 18
  • Pregnancy
  • Indication for major amputation (below /above the knee)
  • Venous ulcer
  • Ulcer with infection and / or necrosis
  • Mycotic ulcer

Information from the National Library of Medicine

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 identifier (NCT number): NCT00820274

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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
Sponsors and Collaborators
University Hospital, Limoges
Etablissement Français du Sang
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Principal Investigator: Francis Pesteil, MD CHU Limoges
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Responsible Party: University Hospital, Limoges Identifier: NCT00820274    
Other Study ID Numbers: I07011
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: December 2013
Additional relevant MeSH terms:
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Pathologic Processes