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Spinal Cord Stimulation for Painful Diabetic Neuropathy and Peripheral Arterial Disease

This study is looking at how high-frequency spinal cord stimulation (SCS) might help people with painful diabetic neuropathy (nerve damage from diabetes) and peripheral arterial disease (PAD), a condition where narrowed arteries reduce blood flow to your limbs. SCS is a treatment that uses mild electrical pulses to block pain signals. While SCS is approved for painful diabetic neuropathy, it hasn't been widely tested for the leg pain caused by PAD. This study will compare active spinal cord stimulation to sham stimulation (a placebo device) to see if it reduces pain. Researchers will measure pain levels at the start, and then at 12, 14, and 16 weeks after the spinal cord stimulator is placed. They plan to enroll up to 15 participants between 19 and 89 years old who have both conditions and significant pain.

Study design
This is an interventional study comparing active spinal cord stimulation to sham stimulation. It plans to enroll up to 15 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 16 weeks after the intervention begins, with pain measurements taken at 12, 14, and 16 weeks.

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NCT06480786

SCS for Patient With Painful Diabetic Neuropathy and Peripheral Arterial Disease

Recruiting
NAAges 19–89InterventionalTreatment
University of Nebraska
~15 participants
Updated 2025-10-22 on ClinicalTrials.gov
What's tested:Spinal cord stimulationSham stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
High-frequency Spinal Cord Stimulation Effect on Analgesia
Measured over Baseline, 12 week follow-up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2

Conditions

Peripheral Arterial Disease
Painful Diabetic Neuropathy
Diabetes Mellitus, Type 2
Chronic Pain
Spinal Cord Stimulation
Chronic Pain Syndrome
Limb Pain

Explore related trials

Chronic PainDiabetes MellitusDiabetic NeuropathyPeripheral Artery Disease

Where it's being run

1 sites across 1 states
Nebraska1

Study leadership

  • Peter Pellegrino, MD · PRINCIPAL_INVESTIGATOR · University of Nebraska

Who to contact

Julia T Hoffman, MSN
[email protected]
402-552-3077
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • High-frequency Spinal Cord Stimulation Effect on AnalgesiaBaseline, 12 week follow-up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2

    The visual analogue scale (VAS) will be used by participants to report lower extremity pain during interventions. The VAS score is a10-cm line that represents a continuum between "no pain" and "worst pain."