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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Skin and Connective Tissue Diseases
• Intervention / Treatment: Drug: Canoderm; Drug: Oviderm; Drug: Decubal

• Study Type: Interventional
• Enrollment (Estimated): 98
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Tautgirdas Ruzgas, Professor; Phone Number: +46406657431; Email: tautgirdas.ruzgas@mau.se

Study Locations

• Sweden
  • Skane
    • Malmö, Skane, Sweden, 21432
      • Recruiting
      • Malmö University
      • Contact: Tautgirdas Ruzgas professor; Phone Number: 46-4057431; Email: tautgirdas.ruzgas@mau.se
      • Contact: Johan Engblom professor; Phone Number: 46-4057483; Email: johan.engblom@mau.se
      • Contact: Christine Kumlien, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Canoderm; Topical on feet twice a day	Drug: Canoderm; humectant
Experimental: Oviderm; Topical on feet twice a day	Drug: Oviderm; humectant + antimicrobial
Active Comparator: Decubal; Topical on feet twice a day	Drug: Decubal; Non-humectant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Xerosis Severity	Change in Xerosis Severity (Scale scores 0 - 6, 6 is the worst)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transepidermal water loss	Trans epidermal water loss (TEWL) (grams per square meter per hour)	4 weeks
Skin resistance	Skin resistance in Ohms (Ω)	4 weeks
Skin Capacitance	Skin Capacitance in Farads (F)	4 weeks
Skin pH	Skin pH (5-8)	4 weeks

Collaborators and Investigators

• Sponsor: Malmö University
• Investigators: Principal Investigator: Christine Kumlien, Professor, Malmö University

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Estimated): November 7, 2025
• Study Completion (Estimated): August 7, 2026

Study Registration Dates

• First Submitted: May 3, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Prevention; Self Care; Dry Skin; Dry Feet
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Connective Tissue Diseases
• Other Study ID Numbers: 2022-500907-27-01

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
• product manufactured in and exported from the U.S.: No