title: 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.
abstract: 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.
authors.affiliation: Irvine3 Circulation-Vascular Labs, Department of Biomedical Sciences, Chieti-Pescara University, Pescara, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Ciammaichella
authors.forename: G
authors.initials: G
authors.lastname: Belcaro
authors.forename: M
authors.initials: M
authors.lastname: Dugall
authors.forename: M
authors.initials: M
authors.lastname: Hosoi
authors.forename: R
authors.initials: R
authors.lastname: Luzzi
authors.forename: E
authors.initials: E
authors.lastname: Ippolito
authors.forename: M R
authors.initials: MR
authors.lastname: Cesarone
mesh_terms: D000279:Administration, Cutaneous; D001120:Arginine / Q000737:chemistry / Q000627:therapeutic use*; D002336:Carnosine / Q000737:chemistry / Q000627:therapeutic use*; D003879:Dermatologic Agents / Q000627:therapeutic use*; D003925:Diabetic Angiopathies / Q000188:drug therapy*; D017719:Diabetic Foot / Q000000981:diagnostic imaging / Q000188:drug therapy*; D004338:Drug Combinations; D004485:Eczema / Q000000981:diagnostic imaging / Q000188:drug therapy*; D005260:Female; D006801:Humans; D017078:Laser-Doppler Flowmetry; D008055:Lipids / Q000737:chemistry; D008297:Male; D008833:Microcirculation; D008875:Middle Aged; D010865:Pilot Projects; D011312:Pressure; D011358:Product Surveillance, Postmarketing; D012867:Skin / Q000473:pathology; D011795:Surveys and Questionnaires; D014463:Ultrasonography; D014508:Urea / Q000737:chemistry / Q000627:therapeutic use*
chemical_list: D003879:Dermatologic Agents; D004338:Drug Combinations; D008055:Lipids; C584745:ureadin Rx Db; D002336:Carnosine; D014508:Urea; D001120:Arginine