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

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.