Other Clinical Trial - Foot Cream for the Care of Dry & Cracked Skin

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Diabetes Mellitus

Clinical Trial Details

NCT number	NCT04474808
Study type	Interventional
Source	West German Center of Diabetes and Health
Contact
Status	Completed
Phase	N/A
Start date	August 1, 2020
Completion date	June 30, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Foot Cream for the Care of Dry and Cracked Skin

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms