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

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Device: BPI 1000013 (Dr Scholls Insole)

• Registration Number: NCT03556787
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-06-04
• Study First Submitted: 2018-06-04
• Study First Submitted QC: 2018-06-04
• Study First Posted: 2018-06-14
• Status Verified: 2018-11
• Primary Completion: 2018-11-08
• Study Completion: 2018-11-08
• Last Update Submitted: 2018-11-20
• Last Update Posted: 2018-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 89

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with knee pain	BPI 1000013 (Dr Scholls Insole)	Adults patients suffering from osteoarthritis pain or general knee pain

Primary Outcome Measures

Name	Time	Method
Osteoarthritis knee pain according to Visual Analog Scale	Up to 4 weeks	100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possible
General anterior knee pain according to Visual Analog Scale	Up to 4 weeks	100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possible

Secondary Outcome Measures

Name	Time	Method
Foot Comfort according to Likert scale	Up to 4 weeks	7-point Comfort/ Discomfort Likert scale, ranging from 1 = Extreme Discomfort to 7 = Extreme Comfort
Number of subjects with serious adverse events	Up to 4 weeks
Shoe Fit according to Likert scale	Up to 4 weeks	7-point Comfort/ Discomfort Likert scale, ranging from -3 = Much too loose fit to 3 = Much too tight fit
Number of subjects with adverse events	Up to 4 weeks

Trial Locations

Locations (2)

Focus & Testing, Inc.; 🇺🇸 Calabasas, California, United States

The Wolf Group; 🇺🇸 Cincinnati, Ohio, United States