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

Resistant Vascular Ulcers Clinical Trial

— MAUV  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00820274
• Other study ID #: I07011
• Status: Terminated
• Phase: Phase 2
• First received: January 9, 2009
• Last updated: August 31, 2015
• Start date: January 2009
• Est. completion date: June 2016

Study information

• Verified date: December 2013
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 2016
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Resistant Vascular Ulcers
• Ulcer

Intervention

Procedure:
• amniotic membranes
The amniotic membrane is taken with a sterile crowbar then applied side foetal face against the ulcer and displayed in a homogeneous way

Locations

Country	Name	City	State
France	Service de Chirurgie Vasculaire et Viscérale	Bordeaux
France	Service de Médecine Interne et Pathologie Vasculaire	Bordeaux
France	Service de Chirurgie Thoracique, cardiovasculaire et angiologie	Limoges

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Limoges	Etablissement Français du Sang

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of the diameter of the ulcer		Every week	No