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

Completed · Not applicable

Conditions studied: Osteoarthritis, Knee

In brief

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.

Key facts

Study ID

NCT03556787

Run by

Bayer

People needed

89

Starts

2018-06-04

Expected to finish

2018-11-08

Last updated by the study team

2018-11-23

Who can join

Age: 18 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male subjects with age 18 to 70 years and a self-reported foot size between 8 and 14
• Subjects with regular knee pain
• Subjects with a baseline pain level of pain of ≥20 mm to ≤90 mm on 100 mm VAS scale at baseline (Visit 1)
• Subjects must be able to walk unaided by cane or walker.

You may not qualify if…

• Subjects with knee pain which is due to a recent injury

Where it is running

• Focus & Testing, Inc. — Calabasas, California, United States
• The Wolf Group — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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