Effects of two creams on dry feet in people 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
This study tests whether two different creams can help people with diabetes improve dry skin on their feet compared to a regular cream.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Malmö University Academic / other |
| Locations | 1 site (Malmö, Skåne County) |
| Trial ID | NCT06427889 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two different pharmaceutical skin care creams designed to treat dry skin on the feet of individuals with diabetes. The study is a randomized controlled trial that compares these creams, which contain different humectants, against a non-humectant cream base. The primary goal is to reduce foot xerosis and assess secondary outcomes related to skin health and diabetes management. Participants will be monitored for changes in skin barrier integrity, microcirculation, and other relevant health markers.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with diabetes mellitus experiencing dry skin on their feet.
Not a fit: Patients with known sensitivities to the cream ingredients or other active foot skin conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved skin care options for diabetic patients, potentially reducing the risk of foot ulcers.
How similar studies have performed: While there is limited research specifically targeting diabetic foot care with these creams, similar approaches have shown promise in managing skin conditions in diabetic patients.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Malmö, Skåne County
- Malmö University — Malmö, Skåne County, Sweden (Recruiting)
Study contacts
- Principal investigator: Christine Kumlien, Professor — Malmo University
- Study coordinator: Tautgirdas Ruzgas, Professor
- Email: tautgirdas.ruzgas@mau.se
- Phone: +46406657431
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.