Treatment Effects of Two Pharmaceutical Skin Care Creams for Xerotic Feet Among Persons With Diabetes

Diabetes Mellitus Clinical Trial

Official title:

A Superiority Study Comparing Two Pharmaceutical Skin Care Creams Containing Different Humectants With a Non-humectant Containing Skin Care Cream for the Treatment of Xerotic Foot of Persons With Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06427889
• Other study ID #: 2022-500907-27-01
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 7, 2024
• Est. completion date: August 7, 2026

Study information

• Verified date: May 2024
• Source: Malmö University
• Contact: Tautgirdas Ruzgas, Professor
• Phone: +46406657431
• Email: tautgirdas.ruzgas[@]mau.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction Diabetic foot-ulcers leads to decreased quality of life, risk of major amputation, and resource demanding health-care. To minimize the risk of developing foot-ulcers, persons with diabetes are given the advice to daily inspect their feet and to apply skincare formulations. However, commercially available skincare products have rarely been developed and evaluated for diabetes foot care specifically. The primary aim of this randomized controlled trial (RCT) is to evaluate the effects in reducing foot xerosis in persons with diabetes without foot-ulcers using two skincare creams containing different humectants (interventions) against a cream base non-humectant (comparator). Secondary outcomes are to evaluate differences on skin barrier integrity, low-molecular weight biomarkers and skin microbiota, microcirculation including transcutaneous oxygen pressure, degree of neuropathy, and HbA1c between intervention-comparator cream. Methods Two-armed double-blind RCT. With 80% power, two-tailed significance of 2.5% in each arm, 39 study persons is needed in each arm, total 78 persons, to be able to prove a reduction of at least one category in the Xerosis Severity Scale with the intervention creams compared to the comparator. In one arm, each participant will treat one foot with one of the intervention creams (Oviderm® or Canoderm®), while the opposite foot will be treated with the comparator cream (Decubal® lipid cream®), twice a day. If needed, participants are enrolled after a wash-out period of two weeks. The participants will undergo examinations at baseline, day 14 and day 28. Discussion This RCT evaluate the potential effects of humectants in skin creams against foot xerosis in persons with diabetes. The outcomes of this trial could have implications on treatment recommendations of foot care and for the prevention of foot ulcer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 98
• Est. completion date: August 7, 2026
• Est. primary completion date: November 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Persons above 18 years of age diagnosed with diabetes mellitus, both type I and II, with self-experienced dry skin.
• Dry skin on both feet with a Xerosis Severity Scale (XSS) score between two to six. No more than one XSS score in difference between the subjects' feet.
• Ability to understand sufficient Swedish language to complete the necessary forms and understand the procedure of the study.

Exclusion Criteria:

• Known sensibility to any of the ingredients in the products.
• Other diagnosed skin disease on the feet.
• Active lesions on either foot.
• Treatment with local medications, including topical moisturizers or keratolytic agents on the feet, within two weeks before the beginning of the study.
• Potential study subjects judged unable to comply with treatment schedule and study specific information.
• Female of childbearing potential that do not use effective medically accepted contraception.

Related Conditions & MeSH terms

• Connective Tissue Diseases
• Diabetes Mellitus
• Skin and Connective Tissue Diseases

Intervention

Drug:
• Canoderm
humectant
• Oviderm
humectant + antimicrobial
• Decubal
Non-humectant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Malmö University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Xerosis Severity	Change in Xerosis Severity (Scale scores 0 - 6, 6 is the worst)	4 weeks
Secondary	Transepidermal water loss	Trans epidermal water loss (TEWL) (grams per square meter per hour)	4 weeks
Secondary	Skin resistance	Skin resistance in Ohms (?)	4 weeks
Secondary	Skin Capacitance	Skin Capacitance in Farads (F)	4 weeks
Secondary	Skin pH	Skin pH (5-8)	4 weeks