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

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

Study Overview

• Status: Completed
• Conditions: Foot Orthoses
• Intervention / Treatment: Device: BPI1000013

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85029
      • Thomas J. Stephens & Associates, Inc.
  • Texas
    • Richardson, Texas, United States, 75081
      • Stephens & Associates, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must be generally healthy and 18 to 65 years of age inclusive;
• Male subjects must have measured foot sizes between size 8.5 and 15. Female subjects must have measured foot sizes between size 8 and 10.5;
• Subjects must be willing to designate 2 pair of shoes with a maximum heel height of 1 ¼ inches, of either casual, work or type of sneakers, for approval of use during the trial. A maximum of 25% of subjects can be sneaker wearers. The 2nd pair of presented shoes must be of the same type. Subjects that wear shoes in the work category may qualify a single pair of shoes as long as the subject wears the same pair of shoes to work every day;
• Subjects must indicate that they currently have heel pain and that they experience heel pain at the end of the day. Subjects that have plantar fasciitis will be identified by the presence of acute pain in the morning upon taking their first steps;
• Subjects must report Heel pain of ≥20 mm to ≤90 mm at the end of their day [assessed on a 100 mm Visual Analog Scale (VAS), where 0=no pain and 100=worst pain possible] at baseline.

Exclusion Criteria:

• Subjects with heel pain due to recent heel spurs, stress fracture or other structural issues;
• Subjects with self-reported alcohol consumption that exceeds moderate consumption (>2 alcoholic beverages per day);
• Subjects with a self-reported history or suspicion of psychiatric disorder, alcohol or drug abuse, including, but not limited to: barbiturate, amphetamine, benzodiazepine, cocaine, opiate, methamphetamine, cannabis abuse;

• Subjects that have received or used an Investigational New Drug in the past 30 days;

  = Subjects that have been enrolled in the last two weeks or are currently participating in a product performance research study or any other type of research, marketing, or product performance study;

• Subjects who are nursing, pregnant, or planning to become pregnant during the course of the study (self-reported);
• Subjects who are employed or have family members employed by Market Research/Marketing Consulting, Manufacturing, Distribution, Retail or Marketing of any type of personal care product, drug product, or pharmaceutical;
• Subjects who have diabetes, circulatory problems, open wounds, and lack of sensation in their feet or any problems that would make insole wear uncomfortable or inappropriate;
• Subjects who wear physician-prescribed orthotic insoles or prescription shoes;
• Subjects who have had a traumatic injury to the lower extremity (deemed of non-overuse nature), which in the opinion of the examining Investigator would interfere with the study evaluations;
• Subjects whose condition requires surgery or other medical intervention or who have undergone foot back or knee surgery within the past 3 months or with any planned surgeries and/or invasive medical procedures during the course of the study;
• Subjects who are currently taking an opioid-based pain medication or have taken such medication within 2 months prior to Visit 1;
• Subjects who are taking any chronic pain medication (prescription or OTC) for at least 2 months, who do not agree to continue taking it at the same dose and regimen throughout the study;
• Subjects who have severely painful bunions, warts, corns and/or calluses, or severely overlapping toes, or lesions on the bottom of their foot;
• Subjects who have sensitivities or allergies to plastics or adhesives;
• Subjects who have conditions which in the opinion of the investigator preclude participation for scientific reasons of compliance, or for reasons of subject's safety;
• Subjects who have any condition that would make study participation inappropriate, as determined by the examining Investigator or designee;
• Subjects with a self-reported history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.), and/or radiation as determined by study documentation;
• Previous assignment to treatment during this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BPI1000013; Subjects suffering from pain associated with plantar fasciitis or general heel pain	Device: BPI1000013; Foam insole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Up to 5 weeks (including screening)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2018
• Primary Completion (Actual): July 26, 2018
• Study Completion (Actual): July 26, 2018

Study Registration Dates

• First Submitted: April 10, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 25, 2018

Study Record Updates

• Last Update Posted (Actual): July 26, 2019
• Last Update Submitted That Met QC Criteria: July 25, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: 20102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No