Short-term SCS for Refractory Diabetic Foot Neuropathic Pain | NCT07740707

NCT07740707

Overview

NCT ID: NCT07740707
Lead Sponsor: Nanchong Central HospitalOTHER_GOV
Official Title: A Prospective Randomized Controlled Study on 14-day Short-term Spinal Cord Stimulation Minimally Invasive Intervention for Patients With Refractory Diabetic Foot Neuropathic Pain
Brief Summary: 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.
Conditions: Refractory Diabetic Foot Neuropathic Pain

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.