Peripheral Neuropathy Trial, Recruiting NCT04658693 Sponsor: VA Office of Research and Development Condition: Peripheral Neuropathy
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Peripheral Neuropathy Trial, Recruiting

NCT04658693
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have had a lower limb amputation, or have lost feeling in your foot due to diabetic nerve damage, and your condition has been stable for some time
  • You are able to stand or walk, with the help of a prosthetic limb or a supportive brace
  • The nerves in your lower leg are still working well enough, as confirmed by standard nerve tests carried out by your doctor
  • You have healthy skin and practice good personal hygiene
  • You do not have immune system problems, epilepsy/seizures, or heart conditions that would make electrical stimulation unsafe
  • You have enough support from family or others, and are able to follow the study schedule and attend follow-up appointments

Who may not be able to join:

  • You currently have open pressure sores or long-lasting skin ulcers
  • Your diabetes is not well controlled, shown by a blood sugar level (HbA1c) of 8.5% or higher
  • You have serious problems with blood flow or circulation in your legs
  • You have a history of wounds that heal poorly
  • You have a history of infections that were difficult to control
  • You currently have an active infection
  • You experience significant pain in your foot, remaining limb, or phantom limb pain
  • You are pregnant
  • You are not able to communicate in English, as the study requires you to describe sensations you feel in your lower limb
  • You have a history of balance or movement disorders that affect your ability to walk steadily
  • Your Body Mass Index (BMI) is above 35 (confirm with trial site if unsure of your BMI category)
  • You have uncontrolled depression, psychosis, or significant memory or thinking difficulties
  • You are likely to need an MRI scan at any point during the study, as MRI is not safe to use with the study's temporary electrode leads in place
  • You have arthritis or joint inflammation in the area where the electrodes would be placed, as this could affect how they are inserted

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Ronald Triolo, PhD, Louis Stokes VA Medical Center, Cleveland, OH

Phone: (216) 791-3800

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
2 March 2021
Est. completion
2 September 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Stimulation thresholds; Functional Gait Assessment (FGA)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov