Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Dec 1, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new method to help individuals who have lost a limb due to diabetes regain some sensation in their lower limbs. Researchers will implant small devices that send gentle electrical signals to the nerves in the remaining part of the leg. These signals are designed to mimic the way the brain would normally receive information from the foot, potentially helping participants feel more connected to their prosthetic limbs. Additionally, there is an option to put recording devices in the muscles to help develop a system that allows for more natural control of a robotic leg.

To participate, individuals must have a stable lower limb amputation due to diabetes and be able to walk with a prosthesis. They should have healthy skin and viable nerves in their legs. However, people with certain conditions, such as uncontrolled diabetes, severe skin issues, or significant mental health challenges, may not be eligible. Participants can expect to undergo various tests and follow-up procedures throughout the study, which aims to improve their mobility and quality of life.

Gender

ALL

Eligibility 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