Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04658693 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Oct 1, 2026 → Oct 1, 2027
See other at-risk trials from VA Office of Research and Development

Record History

  1. Notable Primary and study completion pushed from Oct 1, 2026 to Oct 1, 2027 Eligibility criteria expanded, about 3 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 3 words
  2. Minor Eligibility criteria expanded, about 21 words Secondary endpoints: details revised at 1 of 1 entry Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 1 entry
  3. Minor Enrollment closed, study ongoing Site details revised · Eligibility criteria expanded, about 1 wordv13 Show 2 more changesShow less
    • Site details revised
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Re-verified, no change to tracked fieldsv12
  5. Minor Primary completion moved earlier from Sep 2, 2027 to Oct 1, 2026 Completion moved earlier from May 30, 2031 to Oct 1, 2026 · Collaborators shortened, about 4 wordsv11 Show 2 more changesShow less
    • Completion moved earlier from May 30, 2031 to Oct 1, 2026
    • Collaborators shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  6. Minor Completion pushed from Sep 2, 2027 to May 30, 2031 Site contact updated · Collaborators expanded, about 4 wordsv10 Show 2 more changesShow less
    • Site contact updated
    • Collaborators expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  7. Minor Site contact updatedv9
  8. Minor 3 versions Re-verified since Jan 22, 2024, no change to tracked fieldsv6-v8
  9. Notable Enrollment target: 10 to 15 Primary and study completion dates: Jan 30, 2025 to Sep 2, 2027 · Interventions: Multi contact electrode implant (Device) to Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode (Device) · Study description shortened, about 71 words · 2 morev5 Show 5 more changesShow less
    • Primary and study completion dates: Jan 30, 2025 to Sep 2, 2027
    • Interventions: Multi contact electrode implant (Device) to Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode (Device)
    • Study description shortened, about 71 words
    • Site details revised
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  10. Minor Re-verified, no change to tracked fieldsv4
  11. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 25, 2021 to Mar 2, 2021 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Feb 25, 2021 to Mar 2, 2021
    • Site details revised
  12. Notable Start date: Jan 1, 2021 to Feb 25, 2021v2
  13. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04658693
Lead Sponsor VA Office of Research and Development
Conditions Lower Extremity Amputee, Diabetic Peripheral Neuropathy
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov