Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers

• Register: ClinicalTrials.gov
• Last refreshed on: 14 September 2015
• Main ID: NCT00820274
• Date of registration: 09/01/2009
• Prospective Registration: No
• Primary sponsor: University Hospital, Limoges
• Public title: Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers MAUV
• Scientific title: Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers
• Date of first enrolment: January 2009
• Target sample size: 10
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00820274
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Francis Pesteil, MD
• Affiliation: CHU Limoges

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Resistant Vascular Ulcers

Intervention(s)

Procedure: amniotic membranes

Primary Outcome(s)

Measure of the diameter of the ulcer [Time Frame: Every week]

Secondary ID(s)

I07011

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Etablissement Français du Sang