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Spinal cord stimulation for diabetic nerve pain and poor leg blood flow

Tests spinal stimulation for diabetic nerve pain plus poor leg circulation.

Key facts

Who runs it
University of Nebraska
Where
Omaha, United StatesSee the site
Trial code
Registry title
SCS for Patient With Painful Diabetic Neuropathy and Peripheral Arterial Disease
Status
Recruiting
People taking part
15 people, planned
Started
18 Dec 2024
Expected to end
Jul 2027
Type of study
Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • Spinal cord stimulation
  • Sham stimulation
Record updated
22 October 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with diabetes who have painful nerve damage in the legs and poor blood flow in the legs, and who get a new spinal cord stimulator implant for the study.

Age
19 to 89 years
Sex
All sexes can join.
Disease stage
Diabetes with painful nerve damage (pain score of at least 5 cm (2 in)) and peripheral arterial disease with leg pain on exertion (pain score of at least 6 cm (2.4 in)) for at least 3 months. Peripheral arterial disease is shown by an ankle-brachial index below 0.90 or by vascular imaging.
Earlier treatment
A successful spinal cord stimulator trial (more than 50% relief of chronic leg pain) and a new permanent spinal cord stimulator placed before the study treatment. People with a prior or current spinal cord stimulator implant cannot join.
Biomarker or test result
Ankle-brachial index below 0.90, or vascular imaging that shows peripheral arterial disease.

Main reasons for not taking part

  • Uncontrolled psychological or psychiatric disorder
  • Non-healing wounds or gangrene
  • Critical limb ischemia
  • Prior lower leg or foot amputation
  • Unstable spine on lumbar spine X-rays

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Inability to hold antithrombotic therapy per the American Society of Regional Anesthesia guidelines
  • Prior lower extremity amputation
  • Prior or current spinal cord stimulator implant
  • Uncontrolled psychological or psychiatric disorder
  • Non-healing wounds
  • Gangrene
  • Critical limb ischemia
  • Inability to adhere to study follow-up
  • Mechanical spine instability based on flexion/extension radiographs of the lumbar spine

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 19 and 89 years old?

Where in United States

  • University of Nebraska Medical CenterOmaha, United StatesContact: Michael Lankhorst, MDTaking people

About the trial

What the trial wants to find out

Peripheral arterial disease (PAD) affects over 230 million adults worldwide and is a highly morbid, costly, and disabling condition. Ischemic leg pain drives disability in PAD patients and results from oxygen supply-demand mismatch, autonomic dysfunction, and muscle breakdown. This leg pain, which is unresponsive to traditional pharmacotherapy, limits the patient's tolerance to exercise, which is an important disease-modifying intervention. Spinal cord stimulation is a well-established therapy for medically intractable pain, including painful diabetic neuropathy (PDN) and ischemic pain, but is not part of the standard-of-care for PAD despite limited promising clinical data. Early studies used first-generation, tonic stimulation devices, but with these it was impossible to perform sham-controlled trials to test the treatment. Since then, new types of waveform treatments, including high-frequency spinal cord stimulation (SCS), have been shown to be more effective in the treatment of intractable pain. While high-frequency SCS is approved for PDN treatment, it has never been tested in the treatment of claudication pain from PAD.

Read full original descriptionShow less

This study will enroll up to 15 participants between the ages of 19 and 89 who have PAD and PDN and are successfully implanted with a permanent SCS. Twelve weeks after SCS implantation, participants will receive two weeks of stimulation and two weeks of sham intervention, in random starting order. Blood flow, blood pressure, skin oxygen levels, and participant reported pain int the lower extremities will be assessed before SCS implantation, 12 weeks after SCS implantation and during each of the treatment periods. Participants will also complete a quality of life survey at the same time points. Comparisons of these measurements with the baseline and post-implantation measurements to determine the effects of SCS.

The 2 groups in the trial

  • Active Spinal Cord StimulationTreatment being tested

    Therapeutic spinal cord stimulation titrated at 12 weeks post operative at standard clinical practice.

    Treatment: Spinal cord stimulation

  • Sham StimulationSham treatment, for comparison

    Sub-threshold low frequency spinal cord stimulation to provide no analgesic benefit but serve as a sham control.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Spinal Cord Stimulation for Patients With Painful Diabetic Neuropathy and Peripheral Arterial Disease: Mechanistic Insights From a Single-center, Randomized, Blinded, Sham-controlled Cross-over Proof-of-concept Trial
Plain-language title
Spinal cord stimulation for diabetic nerve pain and poor leg blood flowGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06480786, who can take part
Record updated
22 October 2025