NCT00820274

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University Hospital, Limoges · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Resistant Vascular Ulcers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-01-01
• Primary completion: 2013-12-01
• Completion: 2016-06-01
• First posted: 2009-01-12
• Last updated: 2015-09-01

Locations

3 sites across 1 country: France