check_circleStudy Completed

Foot Orthoses

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

All

Age

18 - 65 Years

Trial summary

Enrollment Goal
102
Trial Dates
April 2018 - July 2018
Phase
N/A
Could I Receive a placebo
No
Products
BPI 1000013
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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 VAS
    VAS (Visual Analog Scale): 100 mm with 0 = no pain and 100 = Worst pain possible
    date_rangeTime Frame:
    Up to 5 weeks (including screening)
  • Foot pain assessment of general heel pain using the 100 mm VAS
    VAS (Visual Analog Scale): 100 mm with 0 = no pain and 100 = Worst pain possible
    date_rangeTime Frame:
    Up to 5 weeks (including screening)

Secondary Outcome

  • Foot Comfort/Discomfort is assessed utilizing a 7-point Comfort/Discomfort Likert scale
    date_rangeTime Frame:
    Up to 4 weeks
  • Shoe/foot Fit with use in shoes is assessed utilizing a 7-point Likert scale
    date_rangeTime Frame:
    Up to 4 weeks
  • Number of subjects with AEs
    date_rangeTime Frame:
    Up to 5 weeks
  • Number of subjects with SAEs
    date_rangeTime Frame:
    Up to 5 weeks

Trial design

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