Status:
TERMINATED
Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers
Lead Sponsor:
University Hospital, Limoges
Collaborating Sponsors:
Etablissement Français du Sang
Conditions:
Resistant Vascular Ulcers
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 infecti...
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...
Eligibility Criteria
Inclusion
- Obtained informed consent
- Leg or foot arterial or mixed ulcer older than at least 3 months
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00820274
Start Date
January 1 2009
End Date
June 1 2016
Last Update
September 1 2015
Active Locations (3)
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1
Service de Médecine Interne et Pathologie Vasculaire
Bordeaux, France, 33075
2
Service de Chirurgie Vasculaire et Viscérale
Bordeaux, France, 33076
3
Service de Chirurgie Thoracique, cardiovasculaire et angiologie
Limoges, France, 87000