An urea, arginine and carnosine cream shows greater efficacy in the treatment of severe xerosis of the feet in type 2 diabetic patients in comparison with standard emollient glycerol cream.
Completed
- Conditions
- Type 2 diabetes mellitus and severe foot skin xerosisNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN13923163
- Lead Sponsor
- Isdin SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
1. Adult men and women, aged between 40 and 75 years,
2. Confirmed diagnosis of type 2 diabetes
3. Moderate-to-severe feet skin dryness,
4. Not used any topical moisturizers on their feet for at least 2 weeks preceding enrolment visit
Exclusion Criteria
1. Insulin dependent diabetes mellitus
2. Presence or past history of foot ulcers lesions
3. Clinical evident peripheral arterial diseases (i.e. ankle/arm systolic blood pressure ratio <0.8)
4. Acute or chronic Charcot osteoarthropathy
5. Clinical significant neuropathy
6. Acute skin diseases and use of drugs that might affect sweating were the main exclusion criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evolution of a 9-point grading Xerosis Assessment Scale (XAS) score (from 0 to 8) and of a 4-point grading Overall Cutaneous Score (OCS) (from 0 to 3) both evaluated at baseline, after 4, 12, and 32 weeks by an investigator unaware of treatment allocation.
- Secondary Outcome Measures
Name Time Method 1. The evolution of skin hydration and desquamation evaluated semi-quantitatively by means of Hydr8®, a bio-impedance analysis device, carried out at baseline and at week 32<br>2. The percentage of patients with very severe skin xerosis (i.e. XAS score>5) at baseline showing an improvement =3 points at the end of 32 weeks of treatment.