Background And Objective: Amniotic membranes are used with success in ophthalmology to treat corneal wounds and ulcers. In this pilot study, we attempt to assess the tolerance of amniotic membranes in the management of resistant venous and/or arterial vascular ulcers.
Material And Methods: We prospectively included 8 patients, 7 males and 1 female, mean age 69.5+/- 9.6 years, with venous and/or arterial ulcers resistant after 6 months with usual medical care and/or after revascularisation failure. Amniotic membranes were applied on a weekly basis with the fetal side on the ulcer, covered by a secondary bandage. The primary end-point was evaluation of tolerance of amniotic membranes on vascular ulcers. The secondary end-points were a >50% reduction of ulcer's area, a significant (P< or =0.05) improvement of pain visual scale score and the quality of life assessed by the SF-36 questionnaire.
Results: Tolerance was excellent in all cases. We observed no adverse effect. We observed complete healing at weeks 19 and 26 for 2 patients and a >50% reduction of ulcer area at weeks 26, 31 and 32 for 3 patients. A sixth patient had an ulcer area reduction <50% and the 2 remaining showed no improvement. A significant improvement was noticed for visual pain scale and the health feeling dimension in the SF-36 questionnaire. No adverse effect or amputation requirement was noted.
Conclusion: These preliminary results are encouraging and require a larger confirmatory study. Further studies are required to clarify the action mode of this therapeutic option.
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