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

Phase 2

Terminated

• Conditions: Resistant Vascular Ulcers
• Interventions: Procedure: amniotic membranes

• Registration Number: NCT00820274
• Lead Sponsor: University Hospital, Limoges

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-09
• Study First Posted: 2009-01-12
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-01
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
amniotic membranes	amniotic membranes	-

Primary Outcome Measures

Name	Time	Method
Measure of the diameter of the ulcer	Every week

Trial Locations

Locations (3)

Service de Médecine Interne et Pathologie Vasculaire; 🇫🇷 Bordeaux, France

Service de Chirurgie Vasculaire et Viscérale; 🇫🇷 Bordeaux, France

Service de Chirurgie Thoracique, cardiovasculaire et angiologie; 🇫🇷 Limoges, France