Type 2 diabetes mellitus and severe foot skin xerosis Nutritional, Metabolic, Endocrine
Conditions
Interventions
Urea 5%, arginine and carnosine cream vs glycerin 40% cream
Sponsors
Isdin SA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 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. | — |
Countries
Italy
Outcome results
None listed