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Device

Spinal Cord Stimulation for Diabetic Neuropathy

N/A
Waitlist Available
Led By Peter Pellegrino, MD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients aged 19 years to 89 years with diabetes mellitus
Signs or symptoms of neuropathy and maximum baseline visual-analog pain scale ≥ 5 cm
Must not have
Non-healing wounds
Walking impairment due to a cause other than PAD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 week follow up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2
Awards & highlights

Summary

This trial involves placing a spinal cord stimulator in people with peripheral arterial disease (PAD) and painful diabetic neuropathy (PDN). Participants must be between 19 and 90 years old, have

Who is the study for?
This trial is for adults aged 19-90 with Type 2 Diabetes who suffer from painful diabetic neuropathy and peripheral arterial disease. They must have significant pain from neuropathy and walking, confirmed PAD via tests, a low quality of life score related to vascular issues, and be suitable candidates for spinal cord stimulation therapy.
What is being tested?
The study compares the effects of actual spinal cord stimulation (SCS) versus sham (fake) stimulation in managing pain due to diabetic neuropathy and poor blood flow in limbs. Participants will undergo SCS placement, followed by two weeks each of real and sham stimulations in random order over four weeks.
What are the potential side effects?
Potential side effects may include discomfort at the implant site, infection risk, possible nerve damage or bleeding during device placement, headache or dizziness when stimulating nerves, changes in blood pressure or heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 19 and 89 years old and have diabetes.
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I experience nerve pain with a severity of at least 5 out of 10.
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I have leg pain from blocked arteries that's been severe for at least 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have wounds that are not healing.
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My walking is impaired for reasons not related to peripheral artery disease.
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I have severe blockage in the arteries of my legs causing pain and ulcers.
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I have had an amputation on my lower limb.
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I use a walking aid that is not a cane.
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My spine is unstable, as shown by specific spine X-rays.
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I have gangrene.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 week follow up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 week follow up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
High-frequency spinal cord stimulation (SCS) effect on analgesia
Secondary study objectives
High-frequency spinal cord stimulation (SCS) effect on automonic control
High-frequency spinal cord stimulation (SCS) effect on blood flow
High-frequency spinal cord stimulation (SCS) effect on quality of life

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Spinal Cord StimulationExperimental Treatment1 Intervention
Therapeutic spinal cord stimulation titrated at 12 weeks post operative at standard clinical practice.
Group II: Sham StimulationPlacebo Group1 Intervention
Sub-threshold low frequency spinal cord stimulation to provide no analgesic benefit but serve as a sham control.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spinal cord stimulation
2022
N/A
~120

Find a Location

Who is running the clinical trial?

Nevro CorpIndustry Sponsor
8 Previous Clinical Trials
1,897 Total Patients Enrolled
University of NebraskaLead Sponsor
554 Previous Clinical Trials
1,145,421 Total Patients Enrolled
Peter Pellegrino, MDPrincipal InvestigatorUniversity of Nebraska
~10 spots leftby Dec 2025
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