Short-term SCS for Refractory Diabetic Foot Neuropathic Pain
Starting soon · Not applicable
Conditions studied: Refractory Diabetic Foot Neuropathic Pain
In brief
This single-center, assessor-blinded randomized controlled trial enrolls 88 patients with drug-refractory diabetic foot neuropathic pain unsuitable for revascularization surgery. Participants are randomized 1:1 to receive standard diabetic foot care alone (control) or standard care plus 14-day short-term spinal cord stimulation (intervention). The primary outcome is pain remission rate at 6 months, with repeated assessments of microcirculation, nerve function, quality of life and adverse events over 6 months. This study evaluates the efficacy and safety of short-term spinal cord stimulation and develops standardized clinical protocols for this minimally invasive therapy.
Key facts
- Study ID
- NCT07740707
- Run by
- Nanchong Central Hospital
- People needed
- 88
- Starts
- 2026-08-01
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-08-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years;
- Confirmed type 2 diabetes mellitus, Wagner grade 1-3 diabetic foot;
- 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;
- Contraindications to lower extremity revascularization surgery, persistent pain after revascularization, or voluntary refusal of vascular surgery;
- Clear consciousness, capable of completing scale assessments and multi-timepoint follow-up;
- Voluntary participation with signed written informed consent.
You may not qualify if…
- Spinal deformity, spinal infection, intraspinal tumor or history of spinal surgery, precluding epidural electrode implantation;
- Severe coagulation disorders, systemic infection or uncontrolled severe active foot infection;
- Severe dysfunction of heart, liver, kidney or respiratory system, unable to tolerate minimally invasive operation;
- Previous spinal cord stimulation or peripheral nerve destructive surgery;
- Psychiatric disorders interfering with assessment and follow-up cooperation;
- Pregnant or lactating women;
- Concurrent enrollment in other clinical trials targeting diabetic foot or chronic pain interventions.
Full record on ClinicalTrials.gov
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