Spinal implant offers new hope for diabetic leg pain
NCT ID NCT05301816
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how well a spinal cord stimulator works in real-world settings for people with long-term leg pain caused by diabetic neuropathy. About 500 participants will receive the implant and be followed for a year. Researchers will measure pain relief, quality of life, and overall improvement.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Spinal cord stimulator (implanted device that sends electrical pulses to the spinal cord)
- What this could lead to
- If successful, this could confirm that spinal cord stimulation is a reliable option for managing hard-to-treat leg pain in people with diabetes.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be less definitive. The device requires surgery and carries risks like infection or lead movement.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 497 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2022
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: To participate in the study, patients must meet all the following inclusion criteria: 1. Have been clinically diagnosed with diabetes, according to the local country diabetes association guidelines, as well as painful diabetic neuropathy (PDN) of the lower limbs refractory to conventional medical management. 2. Average pain intensity (over the last 7 days) of ≥5 out of 10 cm on the Visual Analog Scale (VAS) in the lower limbs at enrollment/baseline. 3. The clinical decision has been made to provide treatment using the Nevro Spinal Cord Stimulation that includes 10 kHz therapy prior to enrollment in the study. 4. Be willing and capable of giving written informed consent. 5. Be willing and able to comply with study-related requirements and procedures and attend all scheduled visits. Exclusion Criteria: To participate in the study, patients must not meet any of the following exclusion criteria: 1. Have a diagnosis of a lower limb mononeuropathy (e.g., causalgia and tibial or peroneal neuropathies), have had a lower limb amputation other than toes, or have large (≥3 cm) and/or gangrenous ulcers of the lower limbs 2. Have a medical condition or diagnosis that is inconsistent with Nevro's SCS System guidelines in the Physician's Manual for the relevant country, or as per standard clinical practice. 3. Have a medical condition or pain in other areas, not intended to be treated in this study, that could interfere with study procedures, accurate pain reporting, and/or confound the evaluation of study endpoints, as determined by the Investigator (such as primary headache, fibromyalgia, post-herpetic neuralgia, osteoarthritis, peripheral vascular disease, or small vessel disease).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Clinical Investigations, LLC
Edmond, Oklahoma, 73013, United States
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Columbia Pain Management
Milwaukie, Oregon, 97222, United States
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Henry Ford Health
West Bloomfield, Michigan, 48322, United States
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Michigan Pain Specialists
Ann Arbor, Michigan, 48108, United States
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Neuroversion, Inc.
Anchorage, Alaska, 99508, United States
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Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
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Virginia Interventional Pain & Spine Centers
Roanoke, Virginia, 24018, United States
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WellSpan Interventional Pain Specialists
York, Pennsylvania, 17402, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Electric pulses may bring back lost foot sensation in diabetes
- Foot exercises show promise for diabetic nerve pain relief
- Could Botox-Like shots ease diabetic foot pain?
- Gene therapy shot aimed at diabetic nerve pain put to the test
- Gene therapy shot aims to ease diabetic foot pain
- Engensis pain treatment checked for Long-Term safety