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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: BPI 1000013 (Dr Scholls Insole)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with knee pain<br>Adults patients suffering from osteoarthritis pain or general knee pain | Device: BPI 1000013 (Dr Scholls Insole)<br>* Full length foam insole<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |