Trial Condition(s):
Osteoarthritis, Knee
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
Bayer Identifier:
20244
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations The Wolf Group Cincinnati, United States, 45242 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Focus & Testing, Inc. Calabasas, United States, 91302 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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
Primary Outcome
- Osteoarthritis knee pain according to Visual Analog Scale100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possibleTimeframe: Up to 4 weeks
- General anterior knee pain according to Visual Analog Scale100 mm Visual Analog Scale: 0 = no pain to 100 = worst pain possibleTimeframe: Up to 4 weeks
Secondary Outcome
- Foot Comfort according to Likert scale7-point Comfort/ Discomfort Likert scale, ranging from 1 = Extreme Discomfort to 7 = Extreme ComfortTimeframe: Up to 4 weeks
- Shoe Fit according to Likert scale7-point Comfort/ Discomfort Likert scale, ranging from -3 = Much too loose fit to 3 = Much too tight fitTimeframe: Up to 4 weeks
- Number of subjects with adverse eventsTimeframe: Up to 4 weeks
- Number of subjects with serious adverse eventsTimeframe: Up to 4 weeks
Additional Information
Not Available
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