Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot (NCT04239222) | Clinical Trial Compass
CompletedNot Applicable
Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot
United States27 participantsStarted 2020-03-10
Plain-language summary
A prospective, interventional, multicenter pilot study to characterize differences in performance and patient reported outcomes between the Taleo, Proflex XC, and the new Revo prosthetic foot.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Person is 18 years or older.
. Currently uses an energy storage and return foot.
. Person has been a unilateral transfemoral (TF), or transtibial (TT) amputee using a prosthesis for at least 1 year.
. For TF amputees, the person must be wearing an Ottobock Microprocessor-controlled Knee (MPK) with a compatible prosthetic foot
. Person weighs ≤ 275 lbs (125 kg) size 26-27cm or ≤ 220 lbs (100 kg) size 24-25cm
. Person is a K3 ambulator based on Medicare Functional Classification Level (MFCL).
. Prosthetic foot size is 24 to 27 centimeters.
. Socket Comfort Score of at least 7
Exclusion criteria
. Current prosthetic foot is too old or worn out as assessed by the CPO.
. TT subject with currently fit with a Proflex XC or TF subject currently fit with a Taleo.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient-perceived Mobility (PLUS-M)™
Timeframe: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot
. Patient is pregnant or planning to become pregnant.
. Person who has a life-threatening medical condition (i.e. terminal cancer, severe heart disease).
. Person has conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking, problems with vestibular system, etc.).
. Ulceration or skin breakdown of the residual limb.
. Person currently has residual limb issues that significantly reduce their ability to load the prosthesis.