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Could zapping nerves save limbs? new study tests electrical stimulation for diabetic neuropathy

NCT ID NCT07696988

Knowledge-focused Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 10, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This study investigates whether targeted electrical stimulation of peripheral nerves can improve blood flow and blood vessel function in the lower limbs of veterans with diabetic peripheral neuropathy. Researchers will measure skin blood flow, vessel density, and oxygen levels using laser and photoacoustic imaging. The goal is to develop a sensitive test for nerve-vessel health and explore whether stimulation can enhance circulation, potentially reducing the risk of limb complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Chronically Implanted Neural and Muscular Interface
What this could lead to
If successful, this could point toward a new way to improve blood flow and prevent limb complications in people with diabetic nerve damage.
What could go wrong
This is a small, early-stage study focused on measuring physiological responses, not treating disease. The device is experimental and may not improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Inclusion Criteria - All Participants: * English-speaking * Veteran Inclusion Criteria - Diabetic Peripheral Neuropathy (DPN) Participants: * Confirmed diagnosis of type 1 or type 2 diabetes mellitus for at least 5 years * Clinical signs and/or symptoms consistent with diabetic peripheral neuropathy Or confirmation of neuropathy via physical exam Inclusion Criteria - Lower Limb Amputees: * Unilateral transtibial or transfemoral amputation * Medically stable for at least 3 months * For the designated subset of the limb-loss cohort (n = 6): implanted with C-FINEs on the sciatic and/or tibial nerves Exclusion Criteria: Exclusion Criteria - All Participants: * Severe neurological disorders impairing ambulation * Visual or hearing impairments interfering with study participation * Cardiovascular or respiratory conditions posing risk during participation * Cognitive or psychiatric conditions compromising informed consent * Participation in other clinical trials interfering with outcomes * Pregnancy * History of photosensitivity or known sensitivity to laser light Additional Exclusion Criteria - Amputees: * Active skin breakdown or infection at residual limb * Significant phantom or residual limb pain interfering with study procedures * Bilateral lower-limb amputation

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Conditions

The condition(s) this trial relates to.

diabetes mellitus diabetic neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes Lower limb amputees

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohio, 44106-1702, United States

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