Diabetes Mellitus, Skin and Connective Tissue Diseases
Conditions
Keywords
Diabetes Mellitus, Dry Skin, Self Care, Dry Feet, 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.
Interventions
Sponsors
Malmö University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Xerosis Severity | 4 weeks | Change in Xerosis Severity (Scale scores 0 - 6, 6 is the worst) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transepidermal water loss | 4 weeks | Trans epidermal water loss (TEWL) (grams per square meter per hour) |
| Skin resistance | 4 weeks | Skin resistance in Ohms (Ω) |
| Skin Capacitance | 4 weeks | Skin Capacitance in Farads (F) |
| Skin pH | 4 weeks | Skin pH (5-8) |
Countries
Sweden
Contacts
Primary ContactTautgirdas Ruzgas, Professor
Outcome results
None listed