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Register:	ISRCTN
Last refreshed on:	6 July 2015
Main ID:	ISRCTN13923163
Date of registration:	24/04/2015
Prospective Registration:	No
Primary sponsor:	Isdin SA
Public title:	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.
Scientific title:	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: a randomized, 8-month, assessor-blinded, controlled trial.
Date of first enrolment:	01/11/2013
Target sample size:	50
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN13923163
Study type:	Interventional
Study design:	A mono-centre prospective, 8-month, randomised, parallel groups, assessor-blinded trial, carried out in a secondary-level diabetic clinic in Italy (Prevention)
Phase:

Countries of recruitment
Italy

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Massimo Milani
Address:	Viale Abruzzi 3 20123 Milan Italy
Telephone:
Email:
Affiliation:

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 diabetes mellitus and severe foot skin xerosis
Nutritional, Metabolic, Endocrine

Intervention(s)

Urea 5%, arginine and carnosine cream vs glycerin 40% cream

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

UR012014

Source(s) of Monetary Support

Isdin SA, Barcelona (Spain)

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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