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Foot Cream for the Care of Dry and Cracked Skin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04474808
Recruitment Status : Recruiting
First Posted : July 17, 2020
Last Update Posted : July 20, 2022
Sponsor:
Collaborator:
Bionatural GmbH
Information provided by (Responsible Party):
Stephan Martin, West German Center of Diabetes and Health

Brief Summary:
In healthy people, but especially in people with diabetes, dry and cracked skin areas on the feet can occur. It is believed that the appearance of dry skin results from a deterioration in the barrier function due to (neuro-) physiological or neuropathic changes in the skin. The standard treatment for skin dryness mainly consists of appropriate care with moisturizing cleaning and care products to protect and restore the barrier function of the skin. Care products containing urea are often used here because urea reduces the feeling of dry and cracked skin due to its moisturizing, keratoplastic, bacteriostatic, antifungal, itch-relieving and proteolytic properties. However, urea-containing preparations can cause painful skin irritation and burning pain on cracked, injured or extremely inflamed skin. Comparable care effects with better tolerance were postulated for care creams enriched with L-arginine. Therefore, a newly developed cream containing 4% L-arginine for the care of dry and cracked skin should be tested in comparison to a conventional care cream containing 5% urea.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Other: L-Arginin containing foot cream Other: Urea-containing foot cream Not Applicable

Detailed Description:

Since the participants are recruited during a routine visit to the outpatient clinic or the study center of the West German Diabetes and Health Center (WDGZ), no visits to the study center are necessary as part of the study.

recruitment

  • Check the inclusion and exclusion criteria
  • Clarification with written confirmation
  • Demographic data (including contact details)
  • Completing the foot care questionnaire (week 0)
  • Delivery of the two creams for the next six weeks
  • Handover questionnaires for week 2, 4 and 6 including prepaid envelopes

Study phase (6 weeks) Participants cream their feet with the study creams twice a day (morning and evening) over a period of six weeks. Since there is no contact with medical study staff during this time, undesirable study effects on the behavior of the participants remain minimal.

The use of other creams or care products (except for cleaning) on the feet is not permitted during the study phase.

Questionnaires Foot care questionnaires are completed after two, four, and six weeks and sent to the study center.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Investigation of the Effectiveness of a Foot Cream Containing L-arginine Compared to a Foot Cream Containing Urea for the Care of Dry and Cracked Skin
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: L-arginine-containing foot cream
The participants apply one foot (randomized assignment) with the L-arginine-containing foot cream twice a day (morning and evening) over a period of six weeks.
Other: L-Arginin containing foot cream
The participants apply one foot (randomized assignment) with the study cream twice a day (morning and evening) over a period of six weeks.

Active Comparator: Urea-containing foot cream
The participants apply one foot (randomized assignment) with the Urea-containing foot cream twice a day (morning and evening) over a period of six weeks.
Other: Urea-containing foot cream
The participants apply one foot (randomized assignment) with the control cream twice a day (morning and evening) over a period of six weeks.




Primary Outcome Measures :
  1. Feet Care Feelings [ Time Frame: 6 weeks ]
    Change in the foot care score (according to the questionnaire) after 6 weeks to feel to what extent the skin is dry, rough, scaly, cracked, irritated or reddened, itchy, painful, smooth, tender, soft or horny.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Appearance of dry and cracked skin on the feet
  • Spoken and written knowledge of German
  • A written declaration of consent is available

Exclusion Criteria:

  • Severe psychiatric illness (e.g. dementia, schizophrenia), which affects the understanding of what the clinical trial is about and the willingness to adhere to the prescribed study procedure
  • The appearance of dry skin or itching as a result of an acute or chronic illness (other than diabetes mellitus) or as a side effect of taking medication
  • Treatment with systemically or locally acting drugs, in which side effects of skin changes or changes in the barrier function of the skin occur and can thus influence the study results
  • Acute clinical symptoms of skin disease on the feet or legs
  • Lower limb amputation or acute diabetic foot syndrome
  • deep wounds on the feet or legs (Wagner stage 2 to 5)
  • Lack of mobility to be able to carry out daily skin care
  • Known allergy or intolerance to individual ingredients of the foot care products used in the study
  • Restricted legal capacity or legal support
  • Participation in other clinical trials with - approved or non-approved - drugs or medical devices

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04474808


Contacts
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Contact: Stephan Martin, MD +49(0)211-5660360 ext 70 stephan.martin@uni-duesseldorf.de
Contact: Kerstin Kempf, PhD +49(0)211-5660360 ext 16 kerstin.kempf@wdgz.de

Locations
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Germany
West German Centre of Diabetes and Health Recruiting
Düsseldorf, Germany, 40591
Contact: Stephan Martin, MD    +49(0)211-5660360 ext 70    stephan.martin@uni-duesseldorf.de   
Contact: Kerstin Kempf, PhD    +49(0)211-5660360 ext 16    kerstin.kempf@wdgz.de   
Principal Investigator: Stephan Martin, MD         
Sponsors and Collaborators
West German Center of Diabetes and Health
Bionatural GmbH
Investigators
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Principal Investigator: Stephan Martin, MD West German Centre of Diabetes and Health
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Responsible Party: Stephan Martin, Director, West German Center of Diabetes and Health
ClinicalTrials.gov Identifier: NCT04474808    
Other Study ID Numbers: Foot cream trial
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No