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

December 18, 2018 updated by: Data Collection Analysis Business Management

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Land O' Lakes, Florida, United States, 33558
        • DCABM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

18-64 years of age male or female, no children, no incarcerated subjects

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue scales
Time Frame: 36 months
By utilizing the Visual analogue scale from the patients' perspective will generate real world data
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Data Collection Analysis Business Management

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2018

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

June 1, 2022

Study Registration Dates

First Submitted

December 18, 2018

First Submitted That Met QC Criteria

December 18, 2018

First Posted (ACTUAL)

December 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 18, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAS1467

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Abscess

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe