SCS for Patient With Painful Diabetic Neuropathy and Peripheral Arterial Disease

NCT06480786 | Recruiting FDA Device

• 1 other identifier: 0623-24-FB
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• High-frequency Spinal Cord Stimulation Effect on Analgesia

  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."

  Baseline, 12 week follow-up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2

Secondary Outcomes (3)

• High-frequency Spinal Cord Stimulation Effect on Quality of Life

  Baseline, 12 week follow up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2

• High-frequency Spinal Cord Stimulation Effect on Blood Flow

  Baseline, 12 week follow up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2

• High-frequency Spinal Cord Stimulation Effect on Autonomic Control

  Baseline, 12 week follow-up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2

Study Arms (2)

Active Spinal Cord Stimulation

EXPERIMENTAL

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

Device: Spinal cord stimulation

Sham Stimulation

SHAM COMPARATOR

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

Device: Sham stimulation

Interventions

Spinal cord stimulation DEVICE

active spinal cord stimulation

Active Spinal Cord Stimulation

Sham stimulation DEVICE

Sham stimulation

Sham Stimulation

Eligibility Criteria

• Age: 19 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• Nevro Corp: collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Related Publications (22)

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MeSH Terms

Conditions

Peripheral Arterial Disease; Diabetic Neuropathies; Diabetes Mellitus, Type 2; Chronic Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Peter Pellegrino, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia T Hoffman, MSN

CONTACT

402-552-3077; outcomesresearch@unmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 cross over design

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: December 18, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)