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A Journal on Physiopathology and Therapy of Chronic Cutaneous Ulcers
Official Journal of the Italian Association for Cutaneous Ulcers
Indexed/Abstracted in: EMBASE, Scopus, Emerging Sources Citation Index
Acta Vulnologica 2008 September;6(3):133-7
Efficacy and tolerability of Fitostimoline® gauze in the epicutaneous treatment of ulcerated dystrophic skin lesions and delayed cicatritial healing
Rafanelli A., Saponati G., Rafanelli S.
Azienda U.S.L. Ravenna Presidio Ospedaliero di Ravenna Divisione di Dermavenereologia, Ravenna, Italia
Aim. To evaluate the efficacy and tolerability of Fitostimoline® gauze in the topical treatment of ulcerated dystrophic skin lesions and delayed cicatritial healing.
Methods. This randomized, control versus placebo, double-blind trial was conducted on 200 outpatients (100 males, 100 females; mean age, 50 years) with ulcerated dystrophic skin lesions and delayed cicatritial healing. One half of the study population received treatment with Fitostimo-line® gauze, the other half a placebo treatment. Assessment was performed at enrolment into the study (base line), at 15 days into therapy, and at the end of treatment. The study protocol was approved by the local ethics committee.
Results. An increased rate of tissue repair and a rapid remission of clinical symptoms were observed in the Fitostimoline-treated group; at final assessment 30/100 lesions had healed completely. A gradual improvement in the clinical picture was also noted in the placebo group but with a complete reepithelialization of 11/100 lesions at final assessment. The difference between the two groups was statistically significant (P<0.01). No local or systemic side effects occurred during the study period.
Conclusion. The results obtained with the study product in this particularly large patient series confirm its well-known efficacy.