E10-E14
Conditions
Interventions
Group 1: The study participants should treat one foot or lower leg with a skin care product (intervention), the second untreated foot or lower leg serves as a control. The selection of the treated or
Sponsors
Diabetes-Klinik Bad Mergentheim
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: To participate in a study, people must meet the following inclusion criteria: • Diabetes mellitus has been present for at least 12 months • Age = 18 years • Appearance of dry skin • German language skills in speaking and writing • Presence of a written consent
Exclusion criteria
Exclusion criteria: Patients are excluded from participating in the study if one of the following exclusion criteria applies: • Known severe psychiatric disease according to ICD-10 (for example, dementia, schizophrenia) that interferes with the understanding of what the clinical trial is about and the willingness to follow the prescribed study procedure • appearance of dry skin or itching as a result of an acute or chronic disease (other than diabetes mellitus) or as a side effect of medication • Treatment with systemic or topical medications that may have side effects such as skin changes or changes in the barrier function of the skin, which may influence the study results • Acute clinical symptoms of a skin disease on feet or legs • Amputation of the lower limbs or presence of an acute diabetic foot syndrome • presence of deep wounds on feet or legs (Wagner Stage 2 to 5) • Lack of flexibility to perform daily skin care • Known allergy or intolerance to individual ingredients of the skin and foot care products / cosmetics used in the study • Person dependent on the sponsor or clinical investigator • Limited ability to work or legal support • Participate in other clinical trials with approved or unapproved medicines or medical devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures are the moisture and fat content as well as the transepidermal water loss of the skin on the feet and legs of the study participants. It is expected that the regular use of the various care products will have a positive impact on the outcome, ie the moisture and fat content of the skin can be increased and the transepidermal water loss can be reduced. The primary study outcomes are changes in skin moisture and fat content and transepidermal water loss from baseline to follow-up. The fat content of the skin (sebum) is determined with a Sebumeter, the skin hydration (hydration) with a Corneometer and the Transepidermaler water loss with a Tewameter of the company Courage + Khazaka. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures include the adherence to daily care (diary), the subjective feelings of the skin, the presence and intensity of itching (pruritus) and the satisfaction of the participants with the care products / cosmetics. The secondary target parameters are recorded by means of a questionnaire and a numerical analogue scale. | — |
Countries
Germany
Contacts
Public ContactMichael Krichbaum
Forschungsinstitut Diabetes-Akademie Mergentheim (FIDAM GmbH)
Outcome results
None listed