Revofit™ System Evaluation on Residual Limb Pain in Amputee Patients (NCT04276714) | Clinical Trial Compass
TerminatedNot Applicable
Revofit™ System Evaluation on Residual Limb Pain in Amputee Patients
Stopped: Not enough patients (difficulty in recruiting according to the inclusion criteria)
France1 participantsStarted 2021-02-22
Plain-language summary
At the early stage of the amputation, the residual limb presents post-surgical fluctuations related to post-operative phase, which would need a frequent prosthetic adjustment. In most cases, the volume of residual limb is constant from 12 to 18 months after surgery. However, some daily fluctuations could appear due to an underlying vascular disease for example, which could be painful and impact the quality of life with a constant need of prosthetics adjustment. The goal of this study is to assess the effectiveness of a system-adjusted fitting in comparison with a standard fitting.
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:
* Patients aged 18 years old and above
* Above knee or below knee amputation (irrespective of etiology and time from amputation)
* Residual limb pain
* Prosthetic with classic fitting
* Fluctuations of residual limb requiring prosthetic adaptation (stump cotton sock, wedgning fitting …)
* Recipients or registered with a social security scheme
* Informed consent form signed beforehand
Exclusion Criteria:
* Patient with peripheral neuropathies contraindicating the use of Revofit system
* Pregnant woman, nursing mother or parturiant
* Patient in detention by judicial or administrative decision
* Patient undergoing psychiatric compulsory care
* Patient in a health or social institution for purposes other than research
* Legally protected person
* Patient unable to express their consent
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.