Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Diabetes Mellitus
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 w...

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.

Tracking Information

NCT #
NCT04474808
Collaborators
Bionatural GmbH
Investigators
Principal Investigator: Stephan Martin, MD West German Centre of Diabetes and Health