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 |
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.
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
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