SCS for Patient With Painful Diabetic Neuropathy and Peripheral Arterial Disease

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT06480786
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
19 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Spinal cord stimulation — DEVICE
    active spinal cord stimulation
  • Sham stimulation — DEVICE
    Sham stimulation

Study Details

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.

Key Dates

Start date
Dec 18, 2024
Status verified
Oct 2025
Primary completion
Jan 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Active Spinal Cord Stimulation
    Therapeutic spinal cord stimulation titrated at 12 weeks post operative at standard clinical practice.
  • Sham Comparator: Sham Stimulation
    Sub-threshold low frequency spinal cord stimulation to provide no analgesic benefit but serve as a sham control.

Primary Outcome Measure

High-frequency Spinal Cord Stimulation Effect on Analgesia [ Time Frame: Baseline, 12 week follow-up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska68198
Michael Lankhorst, MD
[email protected]
402-596-4200

Find similar trials in Omaha, NE

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Nebraska Medical Center· Omaha, NE

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