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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03507478
Recruitment Status : Completed
First Posted : April 25, 2018
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Foot Orthoses Device: BPI1000013 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 10, 2018
Actual Primary Completion Date : July 26, 2018
Actual Study Completion Date : July 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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




Primary Outcome Measures :
  1. Foot pain assessment of plantar fasciitis heel pain using the 100 mm VAS [ Time Frame: Up to 5 weeks (including screening) ]

    VAS (Visual Analog Scale):

    100 mm with 0 = no pain and 100 = Worst pain possible


  2. Foot pain assessment of general heel pain using the 100 mm VAS [ Time Frame: Up to 5 weeks (including screening) ]

    VAS (Visual Analog Scale):

    100 mm with 0 = no pain and 100 = Worst pain possible



Secondary Outcome Measures :
  1. Foot Comfort/Discomfort is assessed utilizing a 7-point Comfort/Discomfort Likert scale [ Time Frame: Up to 4 weeks ]
  2. Shoe/foot Fit with use in shoes is assessed utilizing a 7-point Likert scale [ Time Frame: Up to 4 weeks ]
  3. Number of subjects with AEs [ Time Frame: Up to 5 weeks ]
  4. Number of subjects with SAEs [ Time Frame: Up to 5 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507478


Locations
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United States, Arizona
Thomas J. Stephens & Associates, Inc.
Phoenix, Arizona, United States, 85029
United States, Texas
Stephens & Associates, Inc.
Richardson, Texas, United States, 75081
Sponsors and Collaborators
Bayer
Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03507478    
Other Study ID Numbers: 20102
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases