A tiny shock to the spine: a new hope for diabetic foot pain?
NCT ID NCT07740707
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This trial tests whether a short, 14-day spinal cord stimulation procedure can reduce severe nerve pain in the feet of people with diabetes who haven't found relief from standard treatments. Half of the 88 participants will receive the stimulation plus usual diabetic foot care, while the other half will receive only usual care. The study tracks pain levels, sleep quality, and quality of life over six months to see if this minimally invasive approach offers a meaningful benefit.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- short-term spinal cord stimulation (a minimally invasive procedure)
- What this could lead to
- If it works, this could offer a new, minimally invasive option for people with diabetic foot pain that hasn't responded to standard treatments, potentially easing pain and improving sleep and daily life.
- What could go wrong
- This is a relatively small, single-center trial, and the procedure is invasive, carrying risks like infection or nerve damage. The pain relief may not last beyond the 6-month follow-up, and results may not apply to all patients.
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 88 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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: 1. Age ≥18 years; 2. Confirmed type 2 diabetes mellitus, Wagner grade 1-3 diabetic foot; 3. Persistent moderate-to-severe neuropathic pain (Numeric Rating Scale, NRS ≥4) after ≥3 months of standardized conservative treatment including glycemic control, neurotrophic drugs, multi-modal analgesia and wound care; 4. Contraindications to lower extremity revascularization surgery, persistent pain after revascularization, or voluntary refusal of vascular surgery; 5. Clear consciousness, capable of completing scale assessments and multi-timepoint follow-up; 6. Voluntary participation with signed written informed consent. Exclusion Criteria: 1. Spinal deformity, spinal infection, intraspinal tumor or history of spinal surgery, precluding epidural electrode implantation; 2. Severe coagulation disorders, systemic infection or uncontrolled severe active foot infection; 3. Severe dysfunction of heart, liver, kidney or respiratory system, unable to tolerate minimally invasive operation; 4. Previous spinal cord stimulation or peripheral nerve destructive surgery; 5. Psychiatric disorders interfering with assessment and follow-up cooperation; 6. Pregnant or lactating women; 7. Concurrent enrollment in other clinical trials targeting diabetic foot or chronic pain interventions.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.