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NCT03781024 Clinical Trial

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

Diabetic Foot Ulcer Clinical Trial

Official title:
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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03781024
Other study ID # PAS1467
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date June 1, 2022

Study information
Verified date December 2018
Source Data Collection Analysis Business Management
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 5000
Est. completion date June 1, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Combination Product:
• Footwash
footbath/footwash can help cleanse the wound, remove dead tissue, increase circulation and puts the wound in direct contact with medication to promote faster healing.

Locations
Country Name City State
United States DCABM Land O' Lakes Florida

Sponsors (1)
Lead Sponsor Collaborator
Data Collection Analysis Business Management

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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 Visual Analogue scales By utilizing the Visual analogue scale from the patients' perspective will generate real world data 36 months
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