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

• 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

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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (2)

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

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