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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03556787

Enrollment

Registered

2018-06-14

Start date

2018-06-04

Completion date

2018-11-08

Last updated

2018-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

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.

Interventions

DEVICEBPI 1000013 (Dr Scholls Insole)

Full length foam insole

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Osteoarthritis knee pain according to Visual Analog Scale	Up to 4 weeks	100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possible
General anterior knee pain according to Visual Analog Scale	Up to 4 weeks	100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possible

Secondary

Measure	Time frame	Description
Foot Comfort according to Likert scale	Up to 4 weeks	7-point Comfort/ Discomfort Likert scale, ranging from 1 = Extreme Discomfort to 7 = Extreme Comfort
Shoe Fit according to Likert scale	Up to 4 weeks	7-point Comfort/ Discomfort Likert scale, ranging from -3 = Much too loose fit to 3 = Much too tight fit
Number of subjects with adverse events	Up to 4 weeks	—
Number of subjects with serious adverse events	Up to 4 weeks	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026