Comparison Dry Foot Skin Between Diabetic and Non-diabetic Subjects and the Effects of Two Cosmetic Foot Care Products
- Conditions
- Xerosis Cutis
- Interventions
- Other: 10% Urea foot ointmentOther: 10% Urea foot lotion
- Registration Number
- NCT05046015
- Lead Sponsor
- Galderma R&D
- 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?
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description severe dryness- diabetic 10% Urea foot ointment 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. moderate dryness-diabetic 10% Urea foot lotion 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.
- Primary Outcome Measures
Name Time Method Change from Baseline in Overall Dry Skin Score Baseline; Day 28±2 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
- Secondary Outcome Measures
Name Time Method Skin barrier Day 0, Day 14±1,Day 28±2 Transepidermal water loss: Measurement using the Tewameter®
Three replicate measurements; according to the Technical Procedures G01_A1_V01 g/m2/h
Trial Locations
- Locations (1)
Charité Universitatsmedizin Berlin
🇩🇪Berlin, Germany