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OpenTrials
Completed

NCT Number: NCT03556787

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

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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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Focus & Testing, Inc., Calabasas, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BPI 1000013 (Dr Scholls Insole)

Device

Full length foam insole

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 14, 2018
Registry last updated
Nov 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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