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



Status:Completed
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 70
Updated:11/24/2018
Start Date:June 4, 2018
End Date:November 8, 2018

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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.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- Subjects with knee pain which is due to a recent injury
We found this trial at
2
sites
Cincinnati, Ohio 45242
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Cincinnati, OH
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Calabasas, California 91302
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Calabasas, CA
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