Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers (MAUV)
Primary Purpose
Resistant Vascular Ulcers
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
amniotic membranes
Sponsored by
About this trial
This is an interventional treatment trial for Resistant Vascular Ulcers
Eligibility 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
Sites / Locations
- Service de Médecine Interne et Pathologie Vasculaire
- Service de Chirurgie Vasculaire et Viscérale
- Service de Chirurgie Thoracique, cardiovasculaire et angiologie
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
amniotic membranes
Arm Description
Outcomes
Primary Outcome Measures
Measure of the diameter of the ulcer
Secondary Outcome Measures
Full Information
NCT ID
NCT00820274
First Posted
January 9, 2009
Last Updated
August 31, 2015
Sponsor
University Hospital, Limoges
Collaborators
Etablissement Français du Sang
1. Study Identification
Unique Protocol Identification Number
NCT00820274
Brief Title
Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers
Acronym
MAUV
Official Title
Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Terminated
Why Stopped
clinical trial have encountered difficulties enrolling a sufficient number of patients
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
Collaborators
Etablissement Français du Sang
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resistant Vascular Ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
amniotic membranes
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
amniotic membranes
Intervention Description
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 Measure Information:
Title
Measure of the diameter of the ulcer
Time Frame
Every week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis Pesteil, MD
Organizational Affiliation
CHU Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Médecine Interne et Pathologie Vasculaire
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Service de Chirurgie Vasculaire et Viscérale
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Service de Chirurgie Thoracique, cardiovasculaire et angiologie
City
Limoges
ZIP/Postal Code
87000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers
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