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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BPI1000013 | Experimental | Subjects suffering from pain associated with plantar fasciitis or general heel pain |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPI1000013 | Device | Foam insole |
|
| 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) |
| Measure | Description | 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 |
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Inclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas J. Stephens & Associates, Inc. | Phoenix | Arizona | 85029 | United States | ||
| Stephens & Associates, Inc. |
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| Number of subjects with AEs | Up to 5 weeks |
| Number of subjects with SAEs | Up to 5 weeks |
| Richardson |
| Texas |
| 75081 |
| United States |