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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03556787
Recruitment Status : Completed
First Posted : June 14, 2018
Last Update Posted : November 23, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

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.


Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: BPI 1000013 (Dr Scholls Insole) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 4, 2018
Actual Primary Completion Date : November 8, 2018
Actual Study Completion Date : November 8, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with knee pain
Adults patients suffering from osteoarthritis pain or general knee pain
Device: BPI 1000013 (Dr Scholls Insole)
Full length foam insole




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556787


Locations
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United States, California
Focus & Testing, Inc.
Calabasas, California, United States, 91302
United States, Ohio
The Wolf Group
Cincinnati, Ohio, United States, 45242
Sponsors and Collaborators
Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03556787    
Other Study ID Numbers: 20244
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: November 23, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases