NCT04474808

Foot Cream for the Care of Dry and Cracked Skin

Investigation of the Effectiveness of a Foot Cream Containing L-arginine Compared to a Foot Cream Containing Urea for the Care of Dry and Cracked Skin

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: West German Center of Diabetes and Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	L-Arginin containing foot cream	The participants apply one foot (randomized assignment) with the study cream twice a day (morning and evening) over a period of six weeks.
OTHER	Urea-containing foot cream	The participants apply one foot (randomized assignment) with the control cream twice a day (morning and evening) over a period of six weeks.

Timeline

• Start date: 2020-08-01
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2020-07-17
• Last updated: 2024-01-23

Locations

1 site across 1 country: Germany