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New treatment option for Lower Extremity Amputee
Official title Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy
ClinicalTrials.gov ID: NCT04658693
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Good skin integrity and personal hygiene
- Absence of autoimmune deficiencies, seizure disorders or cardiac abnormalities contraindicating stimulation
You likely can't join if
- 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
See the full eligibility 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
- 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. people 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, people 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
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.