Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT04658693
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04658693
Study Brief:
Protocol Section:
NCT04658693