L89.9 E11
Conditions
Interventions
Group 1: Auralis alternating pressure mattress with Skin IQ - Auralis alternating pressure mattress without Skin IQ
Subjects of this arm lie on the Auralis mattress with SkinIQ topper on the first vi
Sponsors
Charité Campus Charité Mitte
Eligibility
Sex/Gender
Male
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Diabetes mellitus type 2 for at least 5 years according to patient • 50 to 80 years • male • Body Mass Index between 18.5 and 39.99 kg/m2 (normal weight to class II obesity) • Non-Smoker of at least one year • Absence of skin diseases or scars in the skin areas of interest • Ability to move independently and to maintain supine and prone positions • Able to give written informed consent • Skin phototype I to III according to Fitzpatrick classification • Willing and able to fulfil the study requirements
Exclusion criteria
Exclusion criteria: • Disability to maintain in supine or prone position • Acute diseases (e.g. infection) • Unstable chronic systemic disease (e.g. unstable renal insufficiency) • Acute or chronic diseases with increased or decreased body temperature (= 35°C or = 38,5°C, measured in the ear) • History or establishment of atopic dermatitis, psoriasis or other skin disease • Acute or chronic wounds in the skin areas of interest • Any skin affection which may interfere with the study assessment, e.g. tattoo, psoriasis or scar on the investigational sites • Participation in another clinical study 4 weeks before inclusion visit • Current participation in any other clinical study • Any condition/ circumstance (e.g. cognitive impairment, visual impairment) that might interfere with study compliance in the opinion of the investigator • Subject is institutionalized because of legal or regulatory order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Age/Demographics Phototype Diabetes anamnesis Skin surface temperature Stratum corneum hydration (SCH) Skin pH Erythema index Skin stiffness (Uf) Evaluation of resting comfort | — |
Secondary
| Measure | Time frame |
|---|---|
| There will be no distinction between primary and secondary outcomes because of the exploratory character of this study. At V1 and V2 before and after the 2.5 lying phase: skin surface temperature (thermometer), stratum corneum hydration (SCH; with Corneometer(R) Courage&Khazaka), skin pH (pH-meter(R) Courage&Khazaka), erythema index (Chromameter(R) Konica Minolta), skin stiffness (Uf; Cutometer(R) Courage&Khazaka). At V2 after lying phase: resting comfort evaluation. | — |
Countries
Germany
Contacts
Public ContactKathrin Hillmann
Charité – Universitätsmedizin BerlinDept. for Dermatology, Venereology and AllergologyClinical Research Center for Hair and Skin Science
Outcome results
None listed