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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03556787
• Other study ID #: 20244
• Status: Completed
• Phase: N/A
• Start date: June 4, 2018
• Est. completion date: November 8, 2018

Study information

• Verified date: November 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: November 8, 2018
• Est. primary completion date: November 8, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• BPI 1000013 (Dr Scholls Insole)
Full length foam insole

Locations

Country	Name	City	State
United States	Focus & Testing, Inc.	Calabasas	California
United States	The Wolf Group	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Number of subjects with adverse events		Up to 4 weeks
Secondary	Number of subjects with serious adverse events		Up to 4 weeks