check_circleStudy Completed

Osteoarthritis, Knee

Bayer Identifier:

20244

ClinicalTrials.gov Identifier:

NCT03556787

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - 70 Years
  • - 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.

  • - Subjects with knee pain which is due to a recent injury

Trial summary

Enrollment Goal
89
Trial Dates
June 2018 - November 2018
Phase
N/A
Could I Receive a placebo
No
Products
BPI 1000013
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
The Wolf GroupCincinnati, 45242, United States
Completed
Focus & Testing, Inc.Calabasas, 91302, United States

Primary Outcome

  • Osteoarthritis knee pain according to Visual Analog Scale
    100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possible
    date_rangeTime Frame:
    Up to 4 weeks
  • General anterior knee pain according to Visual Analog Scale
    100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possible
    date_rangeTime Frame:
    Up to 4 weeks

Secondary Outcome

  • Foot Comfort according to Likert scale
    7-point Comfort/ Discomfort Likert scale, ranging from 1 = Extreme Discomfort to 7 = Extreme Comfort
    date_rangeTime Frame:
    Up to 4 weeks
  • Shoe Fit according to Likert scale
    7-point Comfort/ Discomfort Likert scale, ranging from -3 = Much too loose fit to 3 = Much too tight fit
    date_rangeTime Frame:
    Up to 4 weeks
  • Number of subjects with adverse events
    date_rangeTime Frame:
    Up to 4 weeks
  • Number of subjects with serious adverse events
    date_rangeTime Frame:
    Up to 4 weeks

Trial design

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
Trial Type
Interventional
Intervention Type
Device
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1