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

• ClinicalTrials.gov Identifier: NCT03556787
• Recruitment Status: Completed
• First Posted: June 14, 2018
• Last Update Posted: November 23, 2018
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis, Knee	Device: BPI 1000013 (Dr Scholls Insole)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 89 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: June 4, 2018
• Actual Primary Completion Date: November 8, 2018
• Actual Study Completion Date: November 8, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Patients with knee pain; Adults patients suffering from osteoarthritis pain or general knee pain	Device: BPI 1000013 (Dr Scholls Insole); Full length foam insole

Outcome Measures

Primary Outcome Measures :

1. Osteoarthritis knee pain according to Visual Analog Scale [ Time Frame: Up to 4 weeks ]
   100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possible
2. General anterior knee pain according to Visual Analog Scale [ Time Frame: Up to 4 weeks ]
   100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possible

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Focus & Testing, Inc.

Calabasas, California, United States, 91302

United States, Ohio

The Wolf Group

Cincinnati, Ohio, United States, 45242

Sponsors and Collaborators

Bayer

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT03556787
• Other Study ID Numbers: 20244
• First Posted: June 14, 2018
• Last Update Posted: November 23, 2018
• Last Verified: November 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases