Foot Cream for the Care of Dry and Cracked Skin

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Treatment

Urea-containing foot cream

L-Arginin containing foot cream

Clinical Study ID

NCT04474808

Foot cream trial

Ages > 18
All Genders
Accepts Healthy Volunteers

Study Summary

In healthy people, but especially in people with diabetes, dry and cracked skin areas on the feet can occur. It is believed that the appearance of dry skin results from a deterioration in the barrier function due to (neuro-) physiological or neuropathic changes in the skin. The standard treatment for skin dryness mainly consists of appropriate care with moisturizing cleaning and care products to protect and restore the barrier function of the skin. Care products containing urea are often used here because urea reduces the feeling of dry and cracked skin due to its moisturizing, keratoplastic, bacteriostatic, antifungal, itch-relieving and proteolytic properties. However, urea-containing preparations can cause painful skin irritation and burning pain on cracked, injured or extremely inflamed skin. Comparable care effects with better tolerance were postulated for care creams enriched with L-arginine. Therefore, a newly developed cream containing 4% L-arginine for the care of dry and cracked skin should be tested in comparison to a conventional care cream containing 5% urea.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Appearance of dry and cracked skin on the feet
Spoken and written knowledge of German
A written declaration of consent is available

Exclusion

Exclusion Criteria:

Severe psychiatric illness (e.g. dementia, schizophrenia), which affects theunderstanding of what the clinical trial is about and the willingness to adhere to theprescribed study procedure
The appearance of dry skin or itching as a result of an acute or chronic illness (other than diabetes mellitus) or as a side effect of taking medication
Treatment with systemically or locally acting drugs, in which side effects of skinchanges or changes in the barrier function of the skin occur and can thus influencethe study results
Acute clinical symptoms of skin disease on the feet or legs
Lower limb amputation or acute diabetic foot syndrome
deep wounds on the feet or legs (Wagner stage 2 to 5)
Lack of mobility to be able to carry out daily skin care
Known allergy or intolerance to individual ingredients of the foot care products usedin the study
Restricted legal capacity or legal support
Participation in other clinical trials with - approved or non-approved - drugs ormedical devices

Study Design

Urea-containing foot cream

August 01, 2020

June 30, 2023

Study Description

Since the participants are recruited during a routine visit to the outpatient clinic or the study center of the West German Diabetes and Health Center (WDGZ), no visits to the study center are necessary as part of the study.

recruitment

Check the inclusion and exclusion criteria
Clarification with written confirmation
Demographic data (including contact details)
Completing the foot care questionnaire (week 0)
Delivery of the two creams for the next six weeks
Handover questionnaires for week 2, 4 and 6 including prepaid envelopes

Study phase (6 weeks) Participants cream their feet with the study creams twice a day (morning and evening) over a period of six weeks. Since there is no contact with medical study staff during this time, undesirable study effects on the behavior of the participants remain minimal.

The use of other creams or care products (except for cleaning) on the feet is not permitted during the study phase.

Questionnaires Foot care questionnaires are completed after two, four, and six weeks and sent to the study center.

Connect with a study center

West German Centre of Diabetes and Health
Düsseldorf, 40591
Germany
Site Not Available

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