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NCT04658693 · ClinicalTrials.gov registry record · NA
Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy
A NA study of Diabetic Peripheral Neuropathy and Lower Extremity Amputee, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT04658693: Recruiting NA study of Diabetic Peripheral Neuropathy and Lower Extremity Amputee, sponsored by VA Office of Research and Development.
NCT04658693 is a NA study of Diabetic Peripheral Neuropathy and Lower Extremity Amputee that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 15 participants, below the 128-participant average among 17 other Diabetic Peripheral Neuropathy trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04658693, a NA study of Diabetic Peripheral Neuropathy and Lower Extremity Amputee, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Quantify the minimum stimulation required to evoke electrically induced sensations on the phantom limb.
Conditions Studied
Interventions
- DEVICE Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode
Study Locations (1)
Ohio
- Louis Stokes VA Medical Center, Cleveland, OH - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-03-02 |
| Est. Completion | 2027-09-02 |
| Phase | NA |
What NCT04658693 shows while recruiting
NCT04658693 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 128-participant average among 17 other Diabetic Peripheral Neuropathy trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Diabetic Peripheral Neuropathy appearing as the primary indexed condition, and to 1 intervention - of which Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode is the first listed.
NCT04658693 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04658693 about?
NCT04658693 is a clinical study titled "Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy". 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 curr...
What is the current status of trial NCT04658693?
This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2021-03-02. Estimated completion is 2027-09-02.
What conditions does trial NCT04658693 study?
This clinical trial studies the following conditions: Diabetic Peripheral Neuropathy, Lower Extremity Amputee.
What interventions are being tested in trial NCT04658693?
The interventions under investigation include: Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode (DEVICE).
Who is sponsoring clinical trial NCT04658693?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04658693 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04658693's enrollment target sits among peer trials
15 18th of 17 the lowest of 17 other Diabetic Peripheral Neuropathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Peripheral Neuropathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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