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

University of Limoges (UL)

Status and phase: Terminated; Phase 2

Conditions: Resistant Vascular Ulcers

Treatments: Procedure: amniotic membranes

Study type: Interventional

Funder types: Other

Identifiers

NCT00820274

I07011

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

amniotic membranes

Experimental group

Treatment:

Procedure: amniotic membranes