Foot Cream for the Care of Dry and Cracked Skin
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|ClinicalTrials.gov Identifier: NCT04474808|
Recruitment Status : Recruiting
First Posted : July 17, 2020
Last Update Posted : July 20, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Other: L-Arginin containing foot cream Other: Urea-containing foot cream||Not Applicable|
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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|
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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Appearance of dry and cracked skin on the feet
- Spoken and written knowledge of German
- A written declaration of consent is available
- 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
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
|Contact: Stephan Martin, MD||+49(0)211-5660360 ext email@example.com|
|Contact: Kerstin Kempf, PhD||+49(0)211-5660360 ext firstname.lastname@example.org|
|West German Centre of Diabetes and Health||Recruiting|
|Düsseldorf, Germany, 40591|
|Contact: Stephan Martin, MD +49(0)211-5660360 ext 70 email@example.com|
|Contact: Kerstin Kempf, PhD +49(0)211-5660360 ext 16 firstname.lastname@example.org|
|Principal Investigator: Stephan Martin, MD|
|Principal Investigator:||Stephan Martin, MD||West German Centre of Diabetes and Health|
|Responsible Party:||Stephan Martin, Director, West German Center of Diabetes and Health|
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|