Clinical trial NCT06427889: Treatment Effects of Two Pharmaceutical Skin Care Creams for Xerotic Feet Among Persons with Diabetes
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Diabetes Mellitus
Skin and Connective Tissue Diseases
Keywords: Diabetes Mellitus
Dry Skin
Self Care
Dry Feet
Prevention
Lead sponsor: Malmö University
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Xerosis Severity
timeFrame: 4 weeks
Secondary outcomes:
measure: Transepidermal water loss
timeFrame: 4 weeks
measure: Skin resistance
timeFrame: 4 weeks
measure: Skin Capacitance
timeFrame: 4 weeks
measure: Skin pH
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Malmö University
state: Skane
Study officials:
affiliation: Malmo University
name: Christine Kumlien, Professor
role: PRINCIPAL_INVESTIGATOR
References: