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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2016-06-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Resistant Vascular Ulcers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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amniotic membranes

Group Type EXPERIMENTAL

amniotic membranes

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No