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

This study is currently recruiting participants.
Verified October 2012 by University Hospital, Limoges
Sponsor:
Collaborator:
Etablissement Français du Sang
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00820274
First received: January 9, 2009
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Resistant Vascular Ulcers
 Procedure: amniotic membranes
 Phase 2

Study Type: Interventional
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

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • Measure of the diameter of the ulcer [ Time Frame: Every week ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: January 2009
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00820274

Contacts
Contact: Pesteil Francis, MD 05 55 05 61 60 francis.pesteil@chu-limoges.fr

Locations
France
Service de Médecine Interne et Pathologie Vasculaire Recruiting
Bordeaux, France, 33075
Contact: Joel CONSTANS, MD     0033556795816     joel.constans@chu-bordeaux.fr    
Principal Investigator: Joel CONSTANS, MD            
Service de Chirurgie Vasculaire et Viscérale Recruiting
Bordeaux, France, 33076
Contact: Dominique Midy, MD     05.56.79.55.26     dominique.midy@chu-bordeaux.fr    
Sub-Investigator: Dominique MIDY, MD            
Service de Chirurgie Thoracique, cardiovasculaire et angiologie Recruiting
Limoges, France, 87000
Contact: Francis PESTEIL, MD     0033555056328     francis.pesteil@chu-limoges.fr    
Principal Investigator: Francis PESTEIL, MD            
Sub-Investigator: Victor ABOYANS, MD            
Sub-Investigator: Marc LASKAR, MD            
Sub-Investigator: Philippe LACROIX, MD            
Sponsors and Collaborators
University Hospital, Limoges
Etablissement Français du Sang
Investigators
Principal Investigator: Francis Pesteil, MD CHU Limoges
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT00820274     History of Changes
Other Study ID Numbers: I07011
Study First Received: January 9, 2009
Last Updated: October 25, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Ulcer
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013