|- candidate number||11265|
|- NTR Number||NTR3328|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-mrt-2012|
|- Secondary IDs||ADI-DB-01-12 |
|- Public Title||Efficacy of topical urea in comparison with standard cream in foot skin xerosis in type 2 diabetic patients: A randomised investigator blinded study.|
|- Scientific Title||Comparison of efficacy of topical 10% urea with standard emollient cream in DASI score in lower arm of type 2 patients.|
|- ACRONYM||Ureadin DB 01|
|- hypothesis||Topical urea is a gold standard treatment for xerosis. Skin xerosis is commonly observed in diabetic subject. A correct hydratation of the skin is advised in order to reduce the risk of skin lesions such as ulcer. No comparative data are available comparing the hydrating and emollient efficacy of topical 10% urea in comparison with standard cream.|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II), DASI score (Dry Assessement Skin Xerosis)|
|- Inclusion criteria||1. Type 2 diabetes in diet or oral treatment;|
2. Hystory of diabetes since at least 6 years;
3. Age 40-80 years;
4. Men or women.
|- Exclusion criteria||1. Diabetic foot;|
2. Severe neuropathy;
3. Severe vasculopathy;
4. Insulin treatment.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2012|
|- planned closingdate||1-apr-2012|
|- Target number of participants||40|
|- Interventions||Investigational product:|
Topical urea in lotion (fluid cream) formulation 10% containing also arginine and carnosine.
Emollient cream containing glycerol.
Both products will be applied 2 times a day on the feet and in the 2/3 distal lower leg.
|- Primary outcome||1. DASI score;|
2. Physician Global Assessement (score scale from 0 to 3).
|- Secondary outcome||Tolerability will be assesed with a patient Assessement score (from 0: very good tolerability tolerability to 3: not tolerated at all) at each visit.|
|- Timepoints||1. Baseline;|
2. Week 2;
3. Week 4.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. Massimo Milani|
|- CONTACT for SCIENTIFIC QUERIES||MD. Massimo Milani|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|- Brief summary||Xerosis is a common skin alteration found in diabetic patients.|
Topical urea is considered a efficaious emollient treatment.
No comparative head-to-head trials have been performed to evaluate hydrating and emollient efficacy between topical products.
|- Main changes (audit trail)|
|- RECORD||1-mrt-2012 - 16-mrt-2012|