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COMPLETED NA

An Evaluation of a Gender Specific Insole to Provide Relief From Knee Pain Due to Osteoarthritis or General Anterior Knee Pain in Male Subjects When Used in Foot Wear Over a Period of Four Weeks

NCT03556787 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of this trial is to demonstrate the ability of a full length foam insole to provide relief from pain due to osteoarthritis of the knee or general knee pain when used in foot wear for a 4-week period of time. The secondary objectives comprise the evaluation of the insole's ability to provide appropriate shoe fit and comfort as well as relief from osteoarthritis/ general knee pain after short-term use. The safety and tolerability of the test articles in terms of adverse events (AE) will also be investigated.

Conditions Studied

Interventions

  • DEVICE BPI 1000013 (Dr Scholls Insole)

Study Locations (2)

California

  • Focus & Testing, Inc. — Calabasas

Ohio

  • The Wolf Group — Cincinnati

Trial Details

FieldValue
Enrollment Target 89 participants
Start Date 2018-06-04
Est. Completion 2018-11-08
Phase NA

Sponsor

Bayer

143 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03556787

The ClinicalTrials.gov registry entry for NCT03556787 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 1 intervention — of which BPI 1000013 (Dr Scholls Insole) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03556787 reports 2 study locations spanning 2 distinct geographic areas — top geographies include California, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03556787 about?

NCT03556787 is a clinical study titled "An Evaluation of a Gender Specific Insole to Provide Relief From Knee Pain Due to Osteoarthritis or General Anterior Knee Pain in Male Subjects When Used in Foot Wear Over a Period of Four Weeks". The primary objective of this trial is to demonstrate the ability of a full length foam insole to provide relief from pain due to osteoarthritis of the knee or general knee pain when used in foot wear for a 4-week period of time. The secondary objectives comprise the evaluation of the insole's abil...

What is the current status of trial NCT03556787?

This trial is currently completed. It is a NA study. The enrollment target is 89 participants. The study started on 2018-06-04. Estimated completion is 2018-11-08.

What conditions does trial NCT03556787 study?

This clinical trial studies the following conditions: Osteoarthritis, Knee. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03556787?

The interventions under investigation include: BPI 1000013 (Dr Scholls Insole) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03556787?

This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03556787 being conducted?

This trial has 2 study locations across California, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial