Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Periphera… (NCT04658693) | Clinical Trial Compass
RecruitingNot Applicable
Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy
United States15 participantsStarted 2021-03-02
Plain-language summary
The purpose of this study is to evaluate the effectiveness of providing sensation of the missing limb to individuals with above and below the knee limb loss. The investigators will implanted stimulating electrodes to send small electrical currents to the remaining nerves. These small electrical currents cause the nerves to generate signals that are then transferred to your brain similar to how the information about your foot and lower limb used to be transferred to the brain prior to your limb loss. Additionally, there is the option to have muscle recording electrodes implanted within the muscles of the lower limb with the goal to develop a motor controller that would allow the user to have intuitive control of a robotic prosthetic leg.
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:
* Chronic, medically stable lower limb amputation due to diabetes or insensate foot due to Diabetic peripheral neuropathy
* Being ambulatory and ability to stand or walk with prosthesis or orthosis
* Viable target nerves in the lower extremity as determined by standard-of-care clinical tests of nerve conduction, response to stimulation, sensory evoked potentials (SEP) and the like
* Good skin integrity and personal hygiene
* Absence of autoimmune deficiencies, seizure disorders or cardiac abnormalities contraindicating stimulation
* Sufficient social support and personal ability to tolerate study procedures and comply with follow-up schedule
Exclusion Criteria:
* Active pressure ulcers or chronic skin ulcerations
* Uncontrolled diabetes with HbA1c greater than or equal to 69 mmol/mol (8.5%)
* Significant vascular disease
* Significant history of poor wound healing
* Significant history of uncontrolled infections
* Active infection
* Significant pain in the foot, residual or phantom limb
* Pregnancy
* Inability to speak English: The study design requires the subject to communicate and describe the elicited sensations in their lower limb
* History of vestibular or movement disorders that would compromise balance or walking
* Class II or III obesity (Body Mass Index \> 35)
* Uncontrolled depression, psychoses or cognitive impairments. Subjects with unstable mental illness or severe cognitive impairments may be unable to comply with a long term study schedu…
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.