Resistant Vascular Ulcers Clinical Trial
Official title:
Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers
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
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment