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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00820274

Acronym

MAUV

Enrollment

Registered

2009-01-12

Start date

2009-01-31

Completion date

2016-06-30

Last updated

2015-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resistant Vascular Ulcers

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.

Interventions

PROCEDUREamniotic membranes

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Measure of the diameter of the ulcer	Every week

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026