Comparison Dry Foot Skin Between Diabetic and Non-diabetic Subjects and the Effects of Two Cosmetic Foot Care Products

Study Overview
=================
Brief Summary
-----------------
The overall aims of this study are to compare the structure and function of dry to very dry and cracked foot skin between diabetic and nondiabetic subjects and to evaluate the effects of two cosmetic leave-on products on dry and fissured diabetic foot skin. Specific issues are: Are there any differences between the morphological and functional characteristics of dry to very dry and cracked skin foot between diabetic and nondiabetic subjects? What are the effects of a 4-week once daily application of an intensive care foot ointment (urea 10% foot ointment) or foot lotion (10% Urea foot lotion) on the skin barrier and on clinical signs of dryness and fissures?

Detailed Description
-----------------
A long existing diabetes mellitus type II is often associated with a number of skin changes. Xerosis Cutis is the most common skin alteration. The risk of diabetics of developing a foot ulcer is estimated to be 15%. Very dry and cracked skin represents an additional risk factor, so that adequate skin care is a widely recommended intervention in diabetic patients. But there are only few studies investigating the skin barrier structure and function in diabetic patients. Available study results seem to suggest, that for instance sebum content, stratum corneum hydration, and pH are associated with Diabetes mellitus. The overall aims of this study are to compare the structure and function of dry to very dry and cracked foot skin between diabetic and nondiabetic subjects and to evaluate the effects of two cosmetic leave-on products on dry and fissured diabetic foot skin. Specific issues are: Are there any differences between the morphological and functional characteristics of dry to very dry and cracked skin foot between diabetic and nondiabetic subjects? What are the effects of a 4-week once daily application of an intensive care foot ointment (urea 10% foot ointment) or foot lotion (10% Urea foot lotion) on the skin barrier and on clinical signs of dryness and fissures?

Official Title
-----------------
Comparing Dry to Very Dry and Cracked Foot Skin Between Diabetic and Non-diabetic Subjects and the Effects of Two Cosmetic leave-on Foot Products: an Exploratory Study

Conditions
-----------------
Xerosis Cutis

Intervention / Treatment
-----------------
* Other: 10% Urea foot lotion
* Other: 10% Urea foot ointment


Participation Criteria
=================
Eligibility Criteria
-----------------
diabetics and non-diabetics Age 40 to 75 years Moderate (categories 3 and 4), severe (category 5) dry skin according to the classification of Rogers et al. 1989 Degree of dryness comparable on both feet (maximum 1 category difference) BMI between 18.5 and 34.9 kg/m2 (normal weight to class I obesity) Able to understand and comply with the study requirements additionally only for diabetics: Diabetes mellitus type 2 for at least 3 years according to Patient Exclusion Criteria: diabetics and non-diabetics Any kind of adverse foot condition except xerosis like nail injury, ulceration, (suspected) infection including fungal infection History of adverse foot condition except xerosis and tinea pedis, like nail injury, ulceration, pain Mild xerosis cutis of feet (categories 1 and 2 according to Rogers et al. 1989) Severe xerosis cutis of feet (category 6 according to Rogers et al. 1989) Gait problems Other non-controlled chronic and/or acute skin disease except xerosis (e.g. atopic dermatitis, psoriasis, tinea pedis) Unstable chronic systemic disease (e.g. hypertension, renal insufficiency) Acute systemic disease (e.g. infection) Body temperature > 38°C Pain anywhere Wear of compression stockings at any time Use of topical steroids Use of skin care leave-on products on the feet in the previous 2 weeks Known hypersensitivity or allergy to product ingredients Drugs that might affect sweating (oral corticosteroids, psychoactive drugs) Topical treatments other than the study products on the test areas within14 days prior Day 0 and during the course of the study Pedicure/ medical foot care 14 days prior D 0 and during the course of the study Any condition/ circumstance (e.g. cognitive impairment, visual impairment) that might interfere with study compliance in the opinion of the investigator Current participation in another clinical study Subject is institutionalized because of legal or regulatory order additionally only for non-diabetics: Diabetes mellitus type 2 according to Patient additionally only for diabetics: Charcot osteoarthropathy Neuropathy tested with a Semmes-Weinstein monofilament (according to Bakker et al. 2012) Absence of pedal pulses (1) Posterior tibial artery (2) Dorsalis pedis artery

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single Blind (Investigator) Non-Randomized 60 [Anticipated]
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: non diabetic<br>Control Group of 20 non-diabetics. Skin measurements, evaluation of skin dryness and sampling of skin particles will be performed | |
| Experimental: moderate dryness-diabetic<br>Experimental: Diabetics with moderate dryness. Intervention Group of 20 diabetics with moderate dryness 10% Urea foot lotion During the course of the study participants cleanse one foot (previously randomized) once daily using the mild cleanser Cetaphil® Restoraderm Body Wash and apply the product Excipial® U10 Lipolotion 10% Urea once daily in the evening by themselves. | Other: 10% Urea foot lotion<br>* During the course of the study participants cleanse one foot (previously randomized) once daily using the mild cleanser Cetaphil® Restoraderm Body Wash and apply the product Excipial® U10 Lipolotion 10% Urea once daily in the evening by themselves.<br>|
| Experimental: severe dryness- diabetic<br>Intervention Group of 20 diabetics with severe dryness 10% Urea foot ointment During the course of the study participants cleanse their feet once daily using the mild cleanser Cetaphil® Restoraderm Body Wash and apply the product Excipial® Fuss Salbe 10% Urea on both feet once daily in the evening by themselves. | Other: 10% Urea foot ointment<br>* During the course of the study participants cleanse one foot (previously randomized) once daily using the mild cleanser Cetaphil® Restoraderm Body Wash and apply the product Excipial® U10 ointment10% Urea once daily in the evening by themselves.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Overall Dry Skin Score | Clinical assessment of the presence or severity of skin dryness using a 7 point scale at the sole of the foot (randomized). A score of '0' indicated normal skin/no sign of dryness, whereas a score of '6' indicates large-scale plates, deep erythematous fissures and cracks | Baseline; Day 28±2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin barrier | Transepidermal water loss: Measurement using the Tewameter® Three replicate measurements; according to the Technical Procedures G01_A1_V01 g/m2/h | Day 0, Day 14±1,Day 28±2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes type II