NCT06427889 Treatment Effects of Two Pharmaceutical Skin Care Creams for Xerotic Feet Among Persons with Diabetes
| NCT ID | NCT06427889 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Malmö University |
| Condition | Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2024-09-04 |
| Primary Completion | 2025-11-07 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 98 participants in total. It began in 2024-09-04 with a primary completion date of 2025-11-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Christine Kumlien, Professor
PRINCIPAL INVESTIGATOR
Malmo University
Frequently Asked Questions
Who can join the NCT06427889 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06427889 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06427889 currently recruiting?
Yes, NCT06427889 is actively recruiting participants. Contact the research team at tautgirdas.ruzgas@mau.se for enrollment information.
Where is the NCT06427889 trial being conducted?
This trial is being conducted at Malmö, Sweden.
Who is sponsoring the NCT06427889 clinical trial?
NCT06427889 is sponsored by Malmö University. The principal investigator is Christine Kumlien, Professor at Malmo University. The trial plans to enroll 98 participants.
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