Plain English Summary
Background and study aims
Xerosis, is an abnormal dryness of the skin. It is one of the most common skin conditions in people with type 2 diabetes. Symptoms include dry, rough skin which, as the condition progresses, becomes red, scaly in appearance. Cracks and fissures may also develop and the skin becomes less elastic and less able to withstand trauma. This can all lead to breaking down of the skin and infections. As yet, there is no long term data available on the effects of emollients in treating severe kin xerosis of the foot in diabetics. Here, we want to investigate how well a urea, arginine and carnosine cream (UC) works in comparison with a glycerin-based emollient cream (SEC), in type 2 diabetics with severe xerosis of the feet.
Who can participate?
Adults aged 40-75 with type 2 diabetes and moderate-to-severe feet skin dryness
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are treated with UC twice a day for 32 weeks. Those in group 2 are treated with SEC twice a day for 32 weeks. The severity of the xerosis is assessed using a 9-point Xerosis-Assessment-Scale (XAS) score and a 4-point Overall-Cutaneous-Score (OCS), at the start of the study, and then after 4, 12 and finally 32 weeks.
What are the possible benefits and risks of participating?
Benefits includes regular visits assess the skin condition of the feet and being supplied with emollients for the duration of the trial. No particular risks have been identified in taking part.
Where is the study run from?
Diabetic Foot Service, Monterotondo, Rome (Italy)
When is the study starting and how long is it expected to run for?
November 2013 to June 2014
Who is funding the study?
Isdin SA, Barcelona (Spain)
Who is the main contact?
Dr Massimo Milani
Trial website
Contact information
Type
Scientific
Primary contact
Dr Massimo Milani
ORCID ID
http://orcid.org/0000-0001-7559-1202
Contact details
Viale Abruzzi 3
Milan
20123
Italy
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
UR012014
Study information
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.
Acronym
Study hypothesis
We evaluated and compared the efficacy of 8-month treatment with urea 5%, arginine 0.4% and carnosine, 0.01% (UC) cream (Ureadin Podos Db cream, Isdin, Spain) in comparison with a standard high content glycerol-based (40%) emollient topical product (SEC) (Neutrogena Norwegian Formula Dermatological Cream, Johnson and Johnson), in type 2 diabetic patients with skin xerosis of lower limbs.
Ethics approval
Diabetic Foot Service Monterotondo Rome (Italy), October 2013
Study design
A mono-centre prospective, 8-month, randomised, parallel groups, assessor-blinded trial, carried out in a secondary-level diabetic clinic in Italy
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Type 2 diabetes mellitus and severe foot skin xerosis
Intervention
Urea 5%, arginine and carnosine cream vs glycerin 40% cream
Intervention type
Drug
Phase
Phase III/IV
Drug names
1. Ureadin Podos Db
2. Neutrogena
Primary outcome measures
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
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.
Overall trial start date
01/11/2013
Overall trial end date
30/06/2014
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant 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
Recruitment start date
01/11/2013
Recruitment end date
01/02/2014
Locations
Countries of recruitment
Italy
Trial participating centre
Diabetic Foot Service
Monterotondo
Rome
Italy
Funders
Funder type
Industry
Funder name
Isdin SA, Barcelona (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Stored in repository
Results - basic reporting
Publication summary