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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-04

Study Completion Date

2018-11-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with knee pain

Adults patients suffering from osteoarthritis pain or general knee pain

Group Type EXPERIMENTAL

BPI 1000013 (Dr Scholls Insole)

Intervention Type DEVICE

Full length foam insole

Interventions

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BPI 1000013 (Dr Scholls Insole)

Full length foam insole

Intervention Type DEVICE

Eligibility Criteria

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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.