Venue: Phoenix Research Center
Venue Phone: 833-530-7596Address:
Compensation: You may be compensated up to $300 for time and travel.
Study Requirements (PLEASE READ – YOU MUST MEET ALL REQUIREMENTS TO APPLY).
- Males and Females
- 18-65 years of age
- Male subjects must have foot size between sizes 8 and 14 (self-reported). Female subjects must have foot size between sizes 6 and 10 (self-reported), Shoe size must not be more than ½ size smaller or larger than self-reported foot size.
- Subjects must wear casual, dress or work shoes or sneakers (no more than 30% total sneaker wearers) with heels of no greater than one and one-quarter inches: (shoes <1 ¼ inches high) for five days out of a typical week.
- Subjects must be willing to wear their qualified 2 pairs of casual, dress or work shoes or sneakers for all sessions during the study Subjects that wear shoes in the work category may qualify 1 pair of shoes as long as the subject wears the same pair of shoes to work every day. Qualified shoes have to be the same type of shoe. Subjects will be allowed to wear an additional pair of non-qualified (e.g., casual shoes or sneakers) shoes after their typical work day;
- All subjects must be willing to wear a pedometer and some subjects wear both a pedometer and an accelerometer each day during the Control and Treatment Phases.
- Subjects must be able to walk unaided by a cane or walker.
- Subjects must not have a noticeable limp or other permanent ailment that interferes with normal gait.
- Subjects must agree not to use OTC pain or anti-inflammatory medications or topical OTC treatments on their feet and legs if not used for management of a chronic condition.
- If subjects are taking pain medication (prescription or OTC) for a chronic condition, they may continue that medication as long as they have been on a stable dose for at least 2 months, and agree to continue their regular dose and regimen for the duration of the study.
- Subjects must be willing to undergo a 2-week period without an added insole and then be willing to wear the assigned insoles for an additional 4 weeks.
- Subjects must have refrained from wearing any non – OEM insert/insoles for a minimum of 1 week before Visit 1.
- Subjects must be willing to complete a diary of their activities outlined in the protocol and provide evidence of completion of the diaries on a weekly basis.
- Subjects must indicate that they feel less energized at the end of their day and are frustrated by not being able to do more during and at the end of the day. Subjects must indicate that they experience fatigue in their feet and legs of 2 or greater according to a 0-5 scale (where 0=no noticeable fatigue and 5=extremely noticeable fatigue) and foot discomfort of 3 or less according to a 1-7 scale (where 1=extreme discomfort and 7=extreme comfort). A maximum of 20% of subjects could be enrolled reporting foot and leg fatigue of a score of 2 and indicating that they have neither foot comfort nor discomfort (score of 4) or slight foot comfort (score of 5).
- Subjects must be willing to wear the test insoles during treatment phase, minimally 5 days per week and 8 hours per day with appropriate shoes that are considered “broken in” by the subject, and that are not excessively worn. Shoe types for Massaging Gel will be dress, casual or sneakers. Shoe types for Massaging Gel Work will be casual or work shoes, or sneakers.
- Subjects must be willing to wear shoes all day before arriving to the clinic. (Non-consecutive hours are acceptable during the typical work day.)
- Subjects will be provided with a maximum of three pair of insoles to be used in their approved pairs of shoes during the Treatment Phase with 1 pair used in their unapproved shoes worn after work hours or on weekends.
- Subjects cannot have any reported pain or injury to the lower body which may interfere with their participation in regular exercise.
- Subjects cannot be participating in sporting activities that could interfere with the accelerometer’s ability to accurately count steps or the accelerometer’s ability to track activities.
- Subjects cannot have an alcohol consumption that exceeds moderate consumption.
- Subjects cannot have history or suspicion of psychiatric disorder, alcohol or drug abuse, including, but not limited to: barbiturate, amphetamine, benzodiazepine, cocaine, opiate, methamphetamine, cannabis abuse.
- Subjects cannot 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 cannot be 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 company.
- Subjects cannot 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 cannot wear a physician-prescribed orthotic insoles or prescription shoes.
- Subjects cannot 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 cannot have a 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 cannot be taking an opioid-based pain medication or have taken such medication within 2 months prior to Visit 1.
- Subjects cannot be 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 cannot have severely painful bunions, warts, corns and/or calluses, severely overlapping toes or lesions on the bottom of their foot.
- Subjects cannot have sensitivities or allergies to plastics or adhesives.
- Subjects cannot have any condition that would make study participation inappropriate, as determined by the examining Investigator or designee.
- Subjects cannot have a 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.
Please apply and one of our recruiters will follow up with you.
- Click Continue to Apply
April 25, 2018 - July 31, 2018
3:35 pm - 4:35 pm