Foot OrthosesNCT03507478
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
A study testing BPI1000013 in people with Foot Orthoses, run by Bayer at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Foot Orthoses
- What is being tested?
- BPI1000013
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Apr 2018to 26 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Thomas J. Stephens & Associates, Inc.
Phoenix, Arizona, 85029
Stephens & Associates, Inc.
Richardson, Texas, 75081
About this study
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
- Conditions
- Foot Orthoses
- Being tested
- BPI1000013
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPI1000013Device
Foam insole
| Study group | Role | What they receive |
|---|---|---|
| BPI1000013 | Experimental | Subjects suffering from pain associated with plantar fasciitis or general heel pain Receives: Device: BPI1000013 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to 5 weeks (including screening)
Secondary outcomes (4)
Foot Comfort/Discomfort is assessed utilizing a 7-point Comfort/Discomfort Likert scale
Measured: Up to 4 weeks
Shoe/foot Fit with use in shoes is assessed utilizing a 7-point Likert scale
Measured: Up to 4 weeks
Number of subjects with AEs
Measured: Up to 5 weeks
Number of subjects with SAEs
Measured: Up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start10 Apr 2018
- Primary completion26 Jul 2018
- Study completion26 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot OrthosesStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507478
- Sponsor's protocol ID
- 20102
- Status last verified
- Jul 2019
- First submitted
- 10 Apr 2018
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03507478
- Acronym / sponsor ID
- 20102
- Conditions
- Foot Orthoses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 26 Jul 2018 (actual)
- Study completion
- 26 Jul 2018 (actual)
- First posted
- 25 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BPI1000013 | Experimental | Device: BPI1000013Subjects suffering from pain associated with plantar fasciitis or general heel pain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPI1000013Foam insole | Device | BPI1000013 |
Primary outcome
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
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
4 secondary outcomes
Foot Comfort/Discomfort is assessed utilizing a 7-point Comfort/Discomfort Likert scale
Time frame: Up to 4 weeks
Shoe/foot Fit with use in shoes is assessed utilizing a 7-point Likert scale
Time frame: Up to 4 weeks
Number of subjects with AEs
Time frame: Up to 5 weeks
Number of subjects with SAEs
Time frame: Up to 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BPI1000013 in people with Foot Orthoses, run by Bayer at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot pain assessment of plantar fasciitis heel pain using the 100 mm VAS (time frame: Up to 5 weeks (including screening)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.