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Could a spinal cord device ease stubborn leg pain in diabetes and PAD?

NCT ID NCT06480786

Symptom relief Sponsor: University of Nebraska Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether high-frequency spinal cord stimulation can reduce leg pain and improve quality of life in people with both peripheral arterial disease (PAD) and painful diabetic neuropathy. Fifteen adults who already have a spinal cord stimulator implanted will receive two weeks of active stimulation and two weeks of sham (inactive) stimulation in random order. Researchers will measure pain, blood flow, skin oxygen levels, and quality of life to see if the device helps beyond a placebo effect.

What this could mean

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

Active substance
spinal cord stimulation (device)
What this could lead to
If it works, this could point toward a new way to manage chronic leg pain in people with both PAD and diabetic neuropathy, improving quality of life.
What could go wrong
This is a very small, early proof-of-concept trial with only 15 participants. The sham control may not fully blind participants, and results may not apply to everyone with these conditions.

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 15 people

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

Started

Dec 2024

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

19 to 89 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * 19 years to 89 years old * Diagnosed diabetes mellitus * Signs or symptoms of neuropathy and maximum baseline visual-analog pain scale ≥ 5 cm and peripheral arterial disease (diagnosed by ankle-brachial index \< 0.90 or vascular imaging studies) with claudication and exertion-induced visual-analog pain scale ≥ 6 cm for a minimum of 3 months * Successful spinal cord stimulator (SCS) trial (\>50% relief of chronic lower extremity pain) and will have a new permanent SCS placed prior to study intervention Exclusion Criteria: * Uncontrolled psychological or psychiatric disorder * Inability to hold antithrombotic therapy per the American Society of Regional Anesthesia guidelines * Non-healing wounds * Gangrene * Critical limb ischemia * Prior lower extremity amputation * Inability to adhere to study follow-up * Mechanical spine instability based on flexion/extension radiographs of the lumbar spine * Prior or current spinal cord stimulator implant

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Conditions

The condition(s) this trial relates to.

Chronic Pain chronic pain syndrome diabetic neuropathy peripheral arterial disease type 2 diabetes mellitus

As listed by the trial registrant

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

Chronic pain Chronic pain syndrome Diabetes mellitus type 2 Limb pain Painful diabetic neuropathy Peripheral arterial disease Spinal cord stimulation

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

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