Toenail Fungal InfectionNCT03781024
A Subjective Observational Study of Patients Using Medicated Footbath/Footwash Treatment in Podiatry Care
An observational study of Toenail Fungal Infection and Cellulitis, run by Data Collection Analysis Business Management at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Toenail Fungal Infection, Cellulitis, Pitted Keratolysis
- What is being tested?
- Footwash
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Study population: 18-64 years of age male or female, no children, no incarcerated subjects
Who may be able to join
- 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
Who cannot join
- -
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Footwash
- Medical subject headings
- Cellulitis, Diabetic Foot, Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FootwashCombination product
Also called Footbath
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (1)
Visual Analogue scales
By utilizing the Visual analogue scale from the patients' perspective will generate real world data
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Dec 2018
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toenail Fungal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Data Collection Analysis Business Management
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781024
- Sponsor's protocol ID
- PAS1467
- Status last verified
- Dec 2018
- First submitted
- 18 Dec 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03781024
- Acronym / sponsor ID
- PAS1467
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Data Collection Analysis Business ManagementUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- 18-64 years of age male or female, no children, no incarcerated subjects
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- -
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FootwashAlso: Footbathfootbath/footwash can help cleanse the wound, remove dead tissue, increase circulation and puts the wound in direct contact with medication to promote faster healing. | Combination product | – |
Primary outcome
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.
1 secondary outcome
Visual Analogue scales
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Toenail Fungal Infection and Cellulitis, run by Data Collection Analysis Business Management at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018; AzTrials last refreshed its copy on 7 Nov 2026.