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

NCT ID: NCT05046015

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-03-31

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?

Conditions

Xerosis Cutis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

non diabetic

Control Group of 20 non-diabetics. Skin measurements, evaluation of skin dryness and sampling of skin particles will be performed

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

10% Urea foot lotion

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

10% Urea foot ointment

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ulrike Blume -Peytavi, Prof Dr.med

Role: PRINCIPAL_INVESTIGATOR

Charité Universitatsmedizin Berlin

Ulrike Blume-Peytavi, Prof Dr.med

Role: PRINCIPAL_INVESTIGATOR

Charité Universitatsmedizin Berlin

Locations

Charité Universitatsmedizin Berlin

Berlin, , Germany

Countries

Germany

Other Identifiers

RD.03.SPR.109799

Identifier Type: -

Identifier Source: org_study_id