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

NCT03781024 | Unknown

• 1 other identifier: PAS1467
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Toenail Fungal Infection; Cellulitis; Pitted Keratolysis; Diabetic Foot Ulcer; Abscess

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Visual Analogue scales

  36 months

Interventions

Footwash COMBINATION_PRODUCT

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.

Also known as: Footbath

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Data Collection Analysis Business Management: lead

Study Sites (1)

DCABM

Land O' Lakes, Florida, 33558, United States

Location

MeSH Terms

Conditions

Cellulitis; Diabetic Foot; Abscess

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 19, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)