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Effect of a Topical Gel Based on Adelmidrol + Trans-Traumatic Acid in the Treatment of Diabetic Foot Ulcers: An Open-Label Study

Ilaria TeobaldiDivision of Endocrinology, Diabetes, and Metabolism, Azienda Ospedaliera Universitaria Integrata of Verona, Verona, Italy.

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Vincenzo StoicoDivision of Endocrinology, Diabetes, and Metabolism, Azienda Ospedaliera Universitaria Integrata of Verona, Verona, Italy.

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Fabrizia PerroneDivision of Endocrinology, Diabetes, and Metabolism, Azienda Ospedaliera Universitaria Integrata of Verona, Verona, Italy.

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Alessandro MantovaniDivision of Endocrinology, Diabetes, and Metabolism, Azienda Ospedaliera Universitaria Integrata of Verona, Verona, Italy.

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Patrizia PiccagliDivision of Endocrinology, Diabetes, and Metabolism, Azienda Ospedaliera Universitaria Integrata of Verona, Verona, Italy.

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Fiorenza GrandiDivision of Endocrinology, Diabetes, and Metabolism, Azienda Ospedaliera Universitaria Integrata of Verona, Verona, Italy.

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Barbara BaldoDivision of Endocrinology, Diabetes, and Metabolism, Azienda Ospedaliera Universitaria Integrata of Verona, Verona, Italy.

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Background: Diabetic foot ulceration is a severe complication of diabetes characterized by chronic inflammation and impaired wound healing. This study aimed to evaluate the effect of a medical device gel based on adelmidrol + trans-traumatic acid in the healing process of diabetic foot ulcers.

Methods: Thirty-seven diabetic patients with foot ulcers of mild/moderate grade were treated with the gel daily for 4 weeks on the affected area. The following parameters were evaluated at baseline and weekly: 1) wound area, measured by drawing a map of the ulcer and then calculated with photo editing software tools, and 2) clinical appearance of the ulcer, assessed by recording the presence/absence of dry/wet necrosis, infection, fibrin, neoepithelium, exudate, redness, and granulation tissue.

Results: Topical treatment led to progressive healing of diabetic foot ulcers with a significant reduction of the wound area and an improvement in the clinical appearance of the ulcers. No treatment-related adverse events were observed.

Conclusions: The results of this open-label study show the potential benefits of adelmidrol + trans-traumatic acid topical administration to promote reepithelialization of diabetic foot ulcers. Further studies are needed to confirm the observed results.

Corresponding author: Ilaria Teobaldi, DPM, Division of Endocrinology, Diabetes, and Metabolism, Azienda Ospedaliera Universitaria Integrata of Verona, Piazzale Aristide Stefani, 1, Verona, 37126 Italy. (E-mail: ilaria.teobaldi@aovr.veneto.it)