Ignite Creation Date:
2024-05-06 @ 2:56 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04474808
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2020-07-13
Brief Title:
Foot Cream for the Care of Dry and Cracked Skin
Sponsor:
West German Center of Diabetes and Health
Organization:
West German Center of Diabetes and Health
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None