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

Bayer

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Device: BPI 1000013 (Dr Scholls Insole)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03556787

20244

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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89 participants in 1 patient group

Patients with knee pain

Experimental group

Description:

Adults patients suffering from osteoarthritis pain or general knee pain

Treatment:

Device: BPI 1000013 (Dr Scholls Insole)