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

NCT06427889 | Recruiting Phase 4 DMC

• 1 other identifier: 2022-500907-27-01
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus; Skin and Connective Tissue Diseases

Keywords

Diabetes Mellitus; Dry Skin; Self Care; Dry Feet; Prevention

Outcome Measures

Primary Outcomes (1)

• Xerosis Severity

  Change in Xerosis Severity (Scale scores 0 - 6, 6 is the worst)

  4 weeks

Secondary Outcomes (4)

• Transepidermal water loss

  4 weeks

• Skin resistance

  4 weeks

• Skin Capacitance

  4 weeks

• Skin pH

  4 weeks

Study Arms (3)

Canoderm

EXPERIMENTAL

Topical on feet twice a day

Drug: Canoderm

Oviderm

EXPERIMENTAL

Topical on feet twice a day

Drug: Oviderm

Decubal

ACTIVE COMPARATOR

Topical on feet twice a day

Drug: Decubal

Interventions

Canoderm DRUG

humectant

Canoderm

Oviderm DRUG

humectant + antimicrobial

Oviderm

Decubal DRUG

Non-humectant

Decubal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Malmö University: lead

Study Sites (1)

Malmö University

Malmo, Skåne County, 21432, Sweden

RECRUITING

Related Publications (1)

• Ericsson A, Borgstrom K, Kumlien C, Gershater Annersten M, Ruzgas T, Engblom J, Gudmundsson P, Lazer V, Jankovskaja S, Lavant E, Agren-Witteschus S, Bjorklund S, Salim S, Astrom M, Acosta S. Treatment effects of two pharmaceutical skin care creams for xerotic feet among persons with diabetes: Rationale and design of a two-armed double blind randomized controlled trial. Contemp Clin Trials Commun. 2024 Sep 16;42:101372. doi: 10.1016/j.conctc.2024.101372. eCollection 2024 Dec.

  PMID: 39345688 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Skin and Connective Tissue Diseases

Interventions

Decubal

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Christine Kumlien, Professor

  Malmo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tautgirdas Ruzgas, Professor

CONTACT

+46406657431; tautgirdas.ruzgas@mau.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor,Biomedical technology, Study director

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 24, 2024
• Study Start: September 4, 2024
• Primary Completion: November 7, 2025
• Study Completion (Estimated): August 7, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)