Study With BioCool Footcare in Subjects With Tinea Pedis Interdigitalis and Heel Cracks, Calluses… (NCT04265521) | Clinical Trial Compass
CompletedNot Applicable
Study With BioCool Footcare in Subjects With Tinea Pedis Interdigitalis and Heel Cracks, Calluses and/or Dry Feet
Sweden25 participantsStarted 2020-03-03
Plain-language summary
A prospective, open, post-market study that will enroll male and female subjects diagnosed with foot fungus and at least one of the following conditions: heel cracks, calluses and/or dry feet. The investigation will consist of approximately 48 subjects (considering a 10% drop-out/screening failure rate) fulfilling the eligibility criteria for the study. Each subject will be treated with the study product, BioCool Footcare (footbath), for 3 weeks. The study duration is estimated to 5 months including recruiting, treatment and follow-up period.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed informed consent form
✓. \> 18 years of age
✓. Males and females
✓. Tinea Pedis (Athlete's foot) confirmed with total symptom score graded between 6-16 (erythema, erosions, macerations, pruritus, fissures, burning/stinging, hyperkeratosis and odour) using a 4-point severity scale (0=absent, 1=mild, 2=moderate and 3=severe). NOTE! maximum total score is 24.
✓. Score of at least 2 (moderate) required in at least one of the following: heel cracks (rhagades), calluses (hyperkeratosis) and dry feet using a 5-point severity scale (0=absent, 1=mild, 2=moderate, 3=advanced and 4=severe).
✓. Patient with confirmed mycological culture
Exclusion criteria
✕. Severe tinea pedis interdigitalis (Athlete's foot) total score of severity grading \>16 (signs and symptoms)
✕. Women pregnant or lactation at time of enrolment