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.
| ISRCTN | ISRCTN13923163 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13923163 |
| Secondary identifying numbers | UR012014 |
- Submission date
- 16/03/2015
- Registration date
- 24/04/2015
- Last edited
- 24/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
Viale Abruzzi 3
Milan
20123
Italy
 ORCID ID |
0000-0001-7559-1202 |
|---|
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Prevention |
| 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. |
| Study objectives | 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(s) | Diabetic Foot Service Monterotondo Rome (Italy), October 2013 |
| Health condition(s) or problem(s) studied | Type 2 diabetes mellitus and severe foot skin xerosis |
| Intervention | Urea 5%, arginine and carnosine cream vs glycerin 40% cream |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | 1. Ureadin Podos Db 2. Neutrogena |
| Primary outcome measure | 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 study start date | 01/11/2013 |
| Completion date | 30/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2013 |
| Date of final enrolment | 01/02/2014 |
Locations
Countries of recruitment
- Italy
Study participating centre
Rome
Italy
Sponsor information
Industry
Calle Provencals 33
Barcelona
20131
Spain
"ROR" |
https://ror.org/04dg86p75 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | |
| IPD sharing plan |
