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| Sponsors and Collaborators: |
University Hospital, Limoges Etablissement Français du Sang |
|---|---|
| Information provided by: | University Hospital, Limoges |
| ClinicalTrials.gov Identifier: | NCT00820274 |
Purpose
To evaluate tolerance and efficiency of cryopreserved amniotic membranes in local treatment of resistant vascular ulcers.
To evaluate complet cicatrisation, efficiency on pain, prevention of infection, improvement of quality of life.
To evaluate rate of amputations and recurrence at one year after complet cicatrisation
| Condition | Intervention | Phase |
|---|---|---|
|
Resistant Vascular Ulcers |
Procedure: amniotic membranes |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers |
| Estimated Enrollment: | 25 |
| Study Start Date: | January 2009 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| amniotic membranes: Experimental |
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
|
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, complet healing, improvement of quality of life by SF36 questionnaire and recurrence at one year for patients with complet healing.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Pesteil Francis, MD | 05 55 05 61 60 | francis.pesteil@chu-limoges.fr |
| France | |
| Service de Chirurgie Thoracique, cardiovasculaire et angiologie | Recruiting |
| Limoges, France, 87000 | |
| Contact: Francis PESTEIL, MD 0033555056328 francis.pesteil@chu-limoges.fr | |
| Principal Investigator: Francis PESTEIL, MD | |
| Sub-Investigator: Victor ABOYANS, MD | |
| Sub-Investigator: Marc LASKAR, MD | |
| Sub-Investigator: Philippe LACROIX, MD | |
| Service de Médecine Interne et Pathologie Vasculaire | Not yet recruiting |
| Bordeaux, France, 33075 | |
| Contact: Joel CONSTANS, MD 0033556795816 joel.constans@chu-bordeaux.fr | |
| Principal Investigator: Joel CONSTANS, MD | |
More Information
| Responsible Party: | CHU Limoges ( CHU Limoges ) |
| Study ID Numbers: | I07011 |
| Study First Received: | January 9, 2009 |
| Last Updated: | January 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00820274 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Ulcer |
|
Pathologic Processes Ulcer |
