Short-term SCS for Refractory Diabetic Foot Neuropathic Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanchong Central Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Standardized Routine Diabetic Foot Therapy
- Standard Routine Therapy + 14-day Short-term Spinal Cord Stimulation
Treatment groups
88 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov