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Clinical Trials/NCT03781024
NCT03781024UnknownNot Applicable

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: Toenail Fungus Ingrown Toenails Cellulitis Athletes' Foot Pitted Keratolysis Diabetic Ulcers Open Infected Sores Abscesses Joint Infections Wound Care

Data Collection Analysis Business Management1 site in 1 country5,000 target enrollmentStarted: December 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
5,000
Locations
1
Primary Endpoint
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

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • Visual Analogue scales(36 months)

Investigators

Sponsor
Data Collection Analysis Business Management
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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