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 Overview

• Status: Terminated
• Conditions: Resistant Vascular Ulcers
• Intervention / Treatment: Procedure: amniotic membranes

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33075
    • Service de Médecine Interne et Pathologie Vasculaire
  • Bordeaux, France, 33076
    • Service de Chirurgie Vasculaire et Viscérale
  • Limoges, France, 87000
    • Service de Chirurgie Thoracique, cardiovasculaire et angiologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measure of the diameter of the ulcer	Every week

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Collaborators: Etablissement Français du Sang
• Investigators: Principal Investigator: Francis Pesteil, MD, CHU Limoges

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): December 1, 2013
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: January 9, 2009
• First Submitted That Met QC Criteria: January 9, 2009
• First Posted (Estimate): January 12, 2009

Study Record Updates

• Last Update Posted (Estimate): September 1, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ulcer
• Other Study ID Numbers: I07011