Foot Cream for the Care of Dry and Cracked Skin

NCT04474808 | Completed

• 1 other identifier: Foot cream trial
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Feet Care Feelings

  Change in the foot care score (according to the questionnaire) after 6 weeks to feel to what extent the skin is dry, rough, scaly, cracked, irritated or reddened, itchy, painful, smooth, tender, soft or horny.

  6 weeks

Study Arms (2)

L-arginine-containing foot cream

EXPERIMENTAL

The participants apply one foot (randomized assignment) with the L-arginine-containing foot cream twice a day (morning and evening) over a period of six weeks.

Other: L-Arginin containing foot cream

Urea-containing foot cream

ACTIVE COMPARATOR

The participants apply one foot (randomized assignment) with the Urea-containing foot cream twice a day (morning and evening) over a period of six weeks.

Other: Urea-containing foot cream

Interventions

L-Arginin containing foot cream OTHER

The participants apply one foot (randomized assignment) with the study cream twice a day (morning and evening) over a period of six weeks.

L-arginine-containing foot cream

Urea-containing foot cream OTHER

The participants apply one foot (randomized assignment) with the control cream twice a day (morning and evening) over a period of six weeks.

Urea-containing foot cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe psychiatric illness (e.g. dementia, schizophrenia), which affects the understanding of what the clinical trial is about and the willingness to adhere to the prescribed 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 skin changes or changes in the barrier function of the skin occur and can thus influence the 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 used in the study
• Restricted legal capacity or legal support
• Participation in other clinical trials with - approved or non-approved - drugs or medical devices

Sponsors & Collaborators

• West German Center of Diabetes and Health: lead
• Bionatural GmbH: collaborator

Study Sites (1)

West German Centre of Diabetes and Health

Düsseldorf, 40591, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Stephan Martin, MD

  West German Centre of Diabetes and Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 17, 2020
• Study Start: August 1, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)