A Subjective Observational Study of Patients Using Medicated Footbath/Footwash Treatment in Podiatry Care

• Conditions: Toenail Fungal Infection; Pitted Keratolysis; Cellulitis; Diabetic Foot Ulcer; Abscess

• Registration Number: NCT03781024
• Lead Sponsor: Data Collection Analysis Business Management

Brief Summary

The purpose of this study is to evaluate the level of relief perceived by patients using medicated footbath/footwash with or without an oral medication for the treatment of podiatry issues.

Detailed Description

Footwash/Footbath for treatment of; Toenail fungus Ingrown toenails Cellulitis Athletes' foot Pitted Keratolysis Diabetic ulcers Open infected sores Abscesses Joint infections Wound care

Study Timeline

• Status Verified: 2018-12
• Study Start: 2018-12-01
• Study First Submitted: 2018-12-18
• Study First Submitted QC: 2018-12-18
• Last Update Submitted: 2018-12-18
• Study First Posted: 2018-12-19
• Last Update Posted: 2018-12-19
• Primary Completion: 2021-12-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Not specified
• Target Recruitment: 5000

Inclusion Criteria

Participants must be diagnosed with an ICD10 code indicative of Toenail Fungus, Ingrown Toenail, Cellulitis, Athletes Foot, Pitted Keratolysis, Diabetic Ulcers, Open infected sores, Abscesses, and Joint infections

• Participants must be starting a new regimen of a medicated footwash/foothbath
• Participants must be expecting to receive therapy for at least 12 weeks
• Participants must be between 18 and 64 years of age
• Participants must be able to provide sound verbal informed consent

Exclusion Criteria

Participants must not be a beneficiary of government funded healthcare program (i.e. Medicare, Medicaid, etc.)

• Participants must not have a diagnosis of cancer within the past 5 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients' perspective through a patient led Survey of Health and quality of life via patient reported outcome measures using Visual analogue scale given at Baseline and follow up. Measuring effectiveness and quality of life from 0 to 10	36 months	Collecting and analyzing quantitative and qualitative data to draw generalized outcome measures, on real world data. Data from the subject surveys will analyze and measure the effectiveness through a subjective observation via patients' perspective survey on footwash with or without oral medication and if it helped with the reduction or elimination of infections.

Secondary Outcome Measures

Name	Time	Method
Visual Analogue scales	36 months	By utilizing the Visual analogue scale from the patients' perspective will generate real world data

Trial Locations

Locations (1)

DCABM; 🇺🇸 Land O' Lakes, Florida, United States