Restoring sensation in amputees with diabetic neuropathy
Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy
This study is testing if implanting electrodes in the nerves of amputees with diabetes can help them feel sensations again and better control a robotic leg.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04658693 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of restoring sensation in individuals with lower limb amputations due to diabetic peripheral neuropathy. It involves surgically implanting electrodes on residual limb nerves to deliver electrical currents that mimic natural sensory feedback. Additionally, intramuscular electrodes may be used to capture muscle signals for controlling a robotic prosthetic leg. Participants will engage in various functional tasks while wearing an instrumented prosthesis that provides sensory feedback corresponding to their movements.
Who should consider this trial
Good fit: Ideal candidates include individuals with chronic lower limb amputations or insensate feet due to diabetic peripheral neuropathy who are ambulatory and able to use a prosthesis.
Not a fit: Patients with active infections, uncontrolled diabetes, or significant vascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for amputees by restoring sensory feedback and enhancing control over prosthetic limbs.
How similar studies have performed: While similar approaches have been explored, this specific method of restoring sensation through implanted electrodes is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 schedule * Expectation that MRI will be required at any point for the duration of study or while percutaneous leads are in place. At this time MRI is contraindicated, subjects who require regular MRI should not enroll * Arthritis in the area of implant- Inflammation or stiffness in the area of implant could limit placement of the electrodes
Where this trial is running
Cleveland, Ohio
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Ronald Triolo, PhD — Louis Stokes VA Medical Center, Cleveland, OH
- Study coordinator: Ronald Triolo, PhD
- Email: ronald.triolo@va.gov
- Phone: (216) 791-3800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.