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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06427889
Other study ID # 2022-500907-27-01
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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