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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 week follow up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2

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.