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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with knee pain | Experimental | Adults patients suffering from osteoarthritis pain or general knee pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPI 1000013 (Dr Scholls Insole) | Device | Full length foam insole |
|
| Measure | Description | Time Frame |
|---|---|---|
| Osteoarthritis knee pain according to Visual Analog Scale | 100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possible | Up to 4 weeks |
| General anterior knee pain according to Visual Analog Scale | 100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possible | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Foot Comfort according to Likert scale | 7-point Comfort/ Discomfort Likert scale, ranging from 1 = Extreme Discomfort to 7 = Extreme Comfort | Up to 4 weeks |
| Shoe Fit according to Likert scale | 7-point Comfort/ Discomfort Likert scale, ranging from -3 = Much too loose fit to 3 = Much too tight fit |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Focus & Testing, Inc. | Calabasas | California | 91302 | United States | ||
| The Wolf Group |
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| Up to 4 weeks |
| Number of subjects with adverse events | Up to 4 weeks |
| Number of subjects with serious adverse events | Up to 4 weeks |
| Cincinnati |
| Ohio |
| 45242 |
| United States |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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