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

NCT03556787 | Completed

• 1 other identifier: 20244
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Foot Comfort according to Likert scale

  Up to 4 weeks

• Shoe Fit according to Likert scale

  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

Study Arms (1)

Patients with knee pain

EXPERIMENTAL

Adults patients suffering from osteoarthritis pain or general knee pain

Device: BPI 1000013 (Dr Scholls Insole)

Interventions

BPI 1000013 (Dr Scholls Insole) DEVICE

Full length foam insole

Patients with knee pain

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (2)

Focus & Testing, Inc.

Calabasas, California, 91302, United States

Location

The Wolf Group

Cincinnati, Ohio, 45242, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 14, 2018
• Study Start: June 4, 2018
• Primary Completion: November 8, 2018
• Study Completion: November 8, 2018
• Last Updated: November 23, 2018

Record last verified: 2018-11

Locations

US (2)