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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.
MedLine Citation:
PMID:  23241933     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
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:
G Ciammaichella; G Belcaro; M Dugall; M Hosoi; R Luzzi; E Ippolito; M R Cesarone
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Panminerva medica     Volume:  54     ISSN:  1827-1898     ISO Abbreviation:  Panminerva Med     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-17     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0421110     Medline TA:  Panminerva Med     Country:  Italy    
Other Details:
Languages:  eng     Pagination:  35-42     Citation Subset:  IM    
Affiliation:
Irvine3 Circulation-Vascular Labs, Department of Biomedical Sciences, Chieti-Pescara University, Pescara, Italy - cardres@abol.it.
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