Short-term SCS for Refractory Diabetic Foot Neuropathic Pain

Официальное название

A Prospective Randomized Controlled Study on 14-day Short-term Spinal Cord Stimulation Minimally Invasive Intervention for Patients With Refractory Diabetic Foot Neuropathic Pain

Обзор

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.

Вмешательства

• Препарат Standardized Routine Diabetic Foot Therapy
  No spinal cord stimulation intervention; unified comprehensive clinical management throughout follow-up: 1. Precise glycemic control: Adjustment of oral hypoglycemic agents or insulin, regular HbA1c monitoring; 2. Basic medication: Neurotrophic agents, lower limb microcirculation improvers, stepwise multi-modal analgesics; 3. Standardized wound care: Debridement, dressing change and foot decompression; 4. Health education: Diabetic diet guidance, foot self-care training and individualized exerc
• Процедура Standard Routine Therapy + 14-day Short-term Spinal Cord Stimulation
  All routine management identical to the control group, with additional 14-day reversible epidural SCS intervention: 1. Epidural electrode implantation targeting T10-T12 spinal segments under local anesthesia; 2. Standardized stimulation parameters set in accordance with domestic clinical guidelines for spinal cord stimulation; electrodes retained for 14 days and removed after the intervention period; 3. Identical follow-up schedule and assessment indicators as the control group.

Первичные конечные точки

• Numerical Rating Scale (NRS) score [Срок оценки: Six months]

Вторичные конечные точки (3)

• Change in Sleep Quality assessed by the Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Six months]
• Change in Physical Health assessed by the 36-Item Short Form Health Survey Physical Component Summary (SF-36 PCS) [Срок оценки: Six months]
• Change in Mental Health assessed by the 36-Item Short Form Health Survey Mental Component Summary (SF-36 MCS) [Срок оценки: Six months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07740707 · 2026010

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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