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Diabetes Mellitus

Foot Cream for the Care of Dry and Cracked Skin

Sponsored by West German Center of Diabetes and Health

About this trial

Last updated a year ago

Study ID

Foot cream trial

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Trial Timing

Ended 2 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- Appearance of dry and cracked skin on the feet

- Spoken and written knowledge of German

- A written declaration of consent is available

No

Exclusion Criteria

- 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

Locations

Location

Status