check_circleStudy Completed
Foot Orthoses
Bayer Identifier:
20102
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
An Evaluation of a Customized Insole to Provide Relief from Heel Pain due to Plantar Fasciitis or General Heel Pain when used in Footwear over a Period of Four Weeks
Trial purpose
The primary objective of this trial will be to demonstrate the ability of a 3/4 length foam insole to provide relief from pain due to plantar fasciitis or general heel pain when used in footwear over a 4-week period of time
Key Participants Requirements
Sex
AllAge
18 - 65 YearsTrial summary
Enrollment Goal
102Trial Dates
April 2018 - July 2018Phase
N/ACould I Receive a placebo
NoProducts
BPI 1000013Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Stephens & Associates, Inc. | Richardson, 75081, United States |
Completed | Thomas J. Stephens & Associates, Inc. | Phoenix, 85029, United States |
Primary Outcome
- Foot pain assessment of plantar fasciitis heel pain using the 100 mm VASVAS (Visual Analog Scale): 100 mm with 0 = no pain and 100 = Worst pain possibledate_rangeTime Frame:Up to 5 weeks (including screening)
- Foot pain assessment of general heel pain using the 100 mm VASVAS (Visual Analog Scale): 100 mm with 0 = no pain and 100 = Worst pain possibledate_rangeTime Frame:Up to 5 weeks (including screening)
Secondary Outcome
- Foot Comfort/Discomfort is assessed utilizing a 7-point Comfort/Discomfort Likert scaledate_rangeTime Frame:Up to 4 weeks
- Shoe/foot Fit with use in shoes is assessed utilizing a 7-point Likert scaledate_rangeTime Frame:Up to 4 weeks
- Number of subjects with AEsdate_rangeTime Frame:Up to 5 weeks
- Number of subjects with SAEsdate_rangeTime Frame:Up to 5 weeks
Trial design
Trial Type
InterventionalIntervention Type
DeviceTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
Single Group AssignmentTrial Arms
1