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Treatment Effects of Two Pharmaceutical Skin Care Creams for Xerotic Feet Among Persons with Diabetes

NCT ID: NCT06427889

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-04

Study Completion Date

2026-08-07

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus Skin and Connective Tissue Diseases

Keywords

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Diabetes Mellitus Dry Skin Self Care Dry Feet Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Canoderm

Topical on feet twice a day

Group Type EXPERIMENTAL

Canoderm

Intervention Type DRUG

humectant

Oviderm

Topical on feet twice a day

Group Type EXPERIMENTAL

Oviderm

Intervention Type DRUG

humectant + antimicrobial

Decubal

Topical on feet twice a day

Group Type ACTIVE_COMPARATOR

Decubal

Intervention Type DRUG

Non-humectant

Interventions

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Canoderm

humectant

Intervention Type DRUG

Oviderm

humectant + antimicrobial

Intervention Type DRUG

Decubal

Non-humectant

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Malmö University

OTHER

Sponsor Role lead

Responsible Party

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Tautgirdas Ruzgas

Professor,Biomedical technology, Study director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christine Kumlien, Professor

Role: PRINCIPAL_INVESTIGATOR

Malmo University

Locations

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Malmö University

Malmo, Skåne County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Tautgirdas Ruzgas, Professor

Role: CONTACT

Phone: +46406657431

Email: [email protected]

Facility Contacts

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Tautgirdas Ruzgas professor

Role: primary

Johan Engblom professor

Role: backup

Christine Kumlien, professor

Role: backup

References

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Ericsson A, Borgstrom K, Kumlien C, Gershater Annersten M, Ruzgas T, Engblom J, Gudmundsson P, Lazer V, Jankovskaja S, Lavant E, Agren-Witteschus S, Bjorklund S, Salim S, Astrom M, Acosta S. Treatment effects of two pharmaceutical skin care creams for xerotic feet among persons with diabetes: Rationale and design of a two-armed double blind randomized controlled trial. Contemp Clin Trials Commun. 2024 Sep 16;42:101372. doi: 10.1016/j.conctc.2024.101372. eCollection 2024 Dec.

Reference Type DERIVED
PMID: 39345688 (View on PubMed)

Other Identifiers

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2022-500907-27-01

Identifier Type: -

Identifier Source: org_study_id