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Panminerva Medica 2012 December;54(1 Suppl 4):35-41

Copyright © 2012 EDIZIONI MINERVA MEDICA

language: English

Product evaluation of Ureadin Rx Db (ISDIN) for prevention and treatment of mild-to-moderate xerosis of the foot in diabetic patients. Prevention of skin lesions due to microangiopathy

Ciammaichella G., Belcaro G., Dugall M., Hosoi M., Luzzi R., Ippolito E., Cesarone M. R.

Irvine3 Circulation-Vascular Labs, Department of Biomedical Sciences, Chieti-Pescara University, Pescara, Italy


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The aim of this pilot, registry study was to evaluate a dermatological solution Ureadin Rx Db (ISDIN) including urea in a water-lipid-based foam delivery system in diabetic subjects with microangiopathy and with mild-to-moderate xerosis of the foot. The product was applied to the whole surface of the foot and particularly on the affected areas and pressure/contact zones, at least twice daily for 4 weeks.
Skin breaks, ulcerations, infection, investigator and patients’ questionnaire, microcirculatory measurements, skin thickness (ultrasound), laser Doppler flux and other parameters were observed and evaluated at inclusion and 4 weeks.
Results. The evaluation in skin breaks indicated a decrease in breaks in the Ureadin group vs controls (p<0.05) with the development of one ulcer in controls.
There was a significant difference in favour of the Ureadin group in both the Investigator global assessment and in the subjects’ assessment questionanire (p<0.05). At 4 weeks PO2 was improved in the Ureadin group (p<0.05) and PCO2 was significantly better (p<0.05) in the Ureadin group. Skin thickness was increased (p<0.05) in the Ureadin group (no change in controls) indicating a better hydration of the more superficial skin layers. Skin flux and the venoarteriolar response were better improved in the Ureadin group. Considering new skin lesions at 4 weeks there were no Class A lesions in the Ureadin group vs. 4 lesions in 26 patients (15.38%; p<0.05) in the control group. There was also a Class B lesion (3.84%; p<0.05) in controls. Diabetic control was good (as before inclusion and did not change at 4 weeks). Therefore the clinical and microcirculatory changes were very possibly due only to local management and not to a systemic improvement in the management of diabetes.

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