Spinal cord stimulation for leg pain from diabetes and poor circulation

Plain-English translation of NCT06480786 on ClinicalTrials.gov ↗ · Source last updated October 2025 · Translation generated June 2026 ·

What is this trial?

This trial is testing spinal cord stimulation—a treatment where a small device is surgically placed near your spinal cord to send gentle electrical signals that may reduce pain—for people who have both painful nerve damage from diabetes and leg pain from poor blood circulation. The study will compare the active treatment to a sham (fake) version to see if the real device truly helps reduce pain and improve quality of life.

Many people with diabetes and poor blood circulation suffer from severe leg pain that doesn't respond well to standard pain medications, and this pain makes it hard to exercise and stay active. While this treatment has been used for other types of chronic pain, it has never been properly tested in a rigorous scientific study for this specific combination of conditions.

Do you qualify?

You likely qualify if…

you are between 19 and 89 years old
you have been diagnosed with diabetes
you have nerve pain from diabetes (pain level of at least 5 on a 10-point scale) and leg pain from poor circulation when walking (pain level of at least 6 on a 10-point scale) that has lasted for at least 3 months
you have poor blood circulation confirmed by a blood pressure test in your ankle or imaging studies
you have already tried a temporary spinal cord stimulator and experienced at least 50% relief of your leg pain
you are willing to have a permanent spinal cord stimulator surgically placed before the study begins

You likely don't qualify if…

you have an untreated serious mental health condition that is not well controlled
you cannot safely take blood-thinning medications as recommended by medical guidelines
you have wounds on your legs that are not healing
you have had a previous amputation of your lower leg or foot
you have critical limb ischemia (severe reduction in blood flow that poses a risk of tissue death) or gangrene

What participation looks like

If you qualify, you will have the spinal cord stimulator permanently implanted, then return for a follow-up visit 12 weeks later for fine-tuning. After that, you will be randomly assigned to receive either the active treatment or a sham (inactive) version for two weeks each, then switch to the other group. Throughout the study, researchers will measure your pain levels and quality of life to see if the treatment helps.

Spinal cord stimulation for leg pain from diabetes and poor circulation

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)