Venous leg ulcers are an important medical issue due to their high incidence in the elderly and the lack of a standard curative approach. Apart from surgical therapy, different medical treatments to effect ulcer wound repair and regeneration are currently being investigated. Sucralfate is a cytoprotective agent employed to prevent or treat several gastrointestinal diseases such as gastroesophageal reflux, gastritis, peptic ulcer, stress ulcer and dyspepsia. In this study we evaluated the efficacy, safety and tolerability of topical sucralfate (SUC-LIS 95) on the healing of chronic venous leg ulcers in 50 patients by a double-blind, placebo-controlled, randomized study. Our results indicated that the daily application of SUC-LIS 95 to non-infected post-phlebitis/vascular ulcers, for a median period of 42.0 days, led to complete healing in 95.6% of patients, against only 10.9% of cases with a matched placebo. A significant improvement was obtained in the SUC-LIS 95-treated patient group with regard to local tissue inflammation as well as pain and burning, and consequently, in ulcer size and the evolution of granulation tissue. Our findings were corroborated for selected patients by the morphological analysis of biopsies obtained before and after treatment. Using ultrastructural analysis we demonstrated that the topical use of SUC-LIS 95 was able to affect neoangiogenesis, increase wound contraction, promote re-epithelialization of the wound area and diminish the inflammatory reaction. Overall, our results indicated that patients with chronic venous ulcers show improvement after the use of topical sucralfate.

Tumino, G., Masuelli, L., Bei, R., Simonelli, L., Santoro, A., Francipane, S. (2008). Topical treatment of chronic venous ulcers with sucralfate: A placebo controlled randomized study. INTERNATIONAL JOURNAL OF MOLECULAR MEDICINE, 22(1), 17-23.

Topical treatment of chronic venous ulcers with sucralfate: A placebo controlled randomized study

BEI, ROBERTO;
2008-01-01

Abstract

Venous leg ulcers are an important medical issue due to their high incidence in the elderly and the lack of a standard curative approach. Apart from surgical therapy, different medical treatments to effect ulcer wound repair and regeneration are currently being investigated. Sucralfate is a cytoprotective agent employed to prevent or treat several gastrointestinal diseases such as gastroesophageal reflux, gastritis, peptic ulcer, stress ulcer and dyspepsia. In this study we evaluated the efficacy, safety and tolerability of topical sucralfate (SUC-LIS 95) on the healing of chronic venous leg ulcers in 50 patients by a double-blind, placebo-controlled, randomized study. Our results indicated that the daily application of SUC-LIS 95 to non-infected post-phlebitis/vascular ulcers, for a median period of 42.0 days, led to complete healing in 95.6% of patients, against only 10.9% of cases with a matched placebo. A significant improvement was obtained in the SUC-LIS 95-treated patient group with regard to local tissue inflammation as well as pain and burning, and consequently, in ulcer size and the evolution of granulation tissue. Our findings were corroborated for selected patients by the morphological analysis of biopsies obtained before and after treatment. Using ultrastructural analysis we demonstrated that the topical use of SUC-LIS 95 was able to affect neoangiogenesis, increase wound contraction, promote re-epithelialization of the wound area and diminish the inflammatory reaction. Overall, our results indicated that patients with chronic venous ulcers show improvement after the use of topical sucralfate.
2008
Pubblicato
Rilevanza internazionale
Articolo
Sì, ma tipo non specificato
Settore MED/04 - PATOLOGIA GENERALE
English
Con Impact Factor ISI
placebo; sucralfate; angiogenesis; antiinflammatory activity; article; biopsy technique; burning sensation; chronic disease; clinical article; clinical trial; controlled clinical trial; controlled study; double blind procedure; drug efficacy; drug response; drug safety; drug tolerability; female; granulation tissue; histopathology; human; human tissue; inflammation; leg ulcer; male; pain assessment; priority journal; randomized controlled trial; treatment duration; ulcer healing; ultrastructure; aged; demography; drug effect; middle aged; pathology; topical drug administration; varicosis; wound healing; Administration, Topical; Aged; Chronic Disease; Demography; Female; Humans; Male; Middle Aged; Placebos; Sucralfate; Varicose Ulcer; Wound Healing
:http://www.spandidos-publications.com/ijmm/
Tumino, G., Masuelli, L., Bei, R., Simonelli, L., Santoro, A., Francipane, S. (2008). Topical treatment of chronic venous ulcers with sucralfate: A placebo controlled randomized study. INTERNATIONAL JOURNAL OF MOLECULAR MEDICINE, 22(1), 17-23.
Tumino, G; Masuelli, L; Bei, R; Simonelli, L; Santoro, A; Francipane, S
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2108/38287
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