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

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

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?

Study Overview

• Status: Completed
• Conditions: Xerosis Cutis
• Intervention / Treatment: Other: 10% Urea foot lotion; Other: 10% Urea foot ointment

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?

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Charite Universitatsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: non diabetic; Control Group of 20 non-diabetics. Skin measurements, evaluation of skin dryness and sampling of skin particles will be performed
Experimental: moderate dryness-diabetic; 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; 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.
Experimental: severe dryness- diabetic; 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; 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.

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stratum corneum hydration	Stratum corneum hydration - Measurement using the Corneometer at Day 28	Day 28
Skin surface pH	Skin surface pH Measurement using the pH-Meter® Three replicate measurements; according to the Technical Procedures G01_A4_V01	Day 0 , Day 14, Day 28
Epidermal thickness	Epidermal thickness Measurement using OCT taking one image/ visit/ test area Mean of three epidermal thickness measurements; according to the Technical Procedures G04_A1_V01 μm	D28
Skin surface topography	Skin surface topography - Measurement using Visioscan®	Day 0, Day 28±2
Elasticity/Stiffness	Elasticity/Stiffness Measurement using Cutometer® at day 28	Day 28
lipids	Oxidative stress on lipids Measurement according to sampling method of Synelvia (Version 2)	Day 0, Day 28
Callus	Callus; Clinical evaluation by study investigator; Classification of Callus severity according to Hashmi et al. 2015	Day 0, Day 28
Cracks/ Fissures	Cracks/ Fissures; Clinical evaluation by study investigator; Classification according to Oe et al. 2012	Day 0, Day 28

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Principal Investigator: Ulrike Blume -Peytavi, Prof Dr.med, Charite Universitatsmedizin Berlin; Principal Investigator: Ulrike Blume-Peytavi, Prof Dr.med, Charite Universitatsmedizin Berlin

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Diabetes type II
• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Carbamide Peroxide
• Other Study ID Numbers: RD.03.SPR.109799

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No