Surgzon

Objective

To evaluate the safety and efficacy of implantation of a one-stage spinal cord stimulation (SCS) system under general anesthesia in patients with high-risk diabetic feet.

Methods

A retrospective analysis was performed on 25 patients who were diagnosed with high-risk diabetic feet and who underwent implantation of an SCS system between January 2023 and May 2024. The procedure was conducted under general anesthesia with intraoperative electrophysiological monitoring. All patients were followed up for one year postoperatively. The outcomes, including pain intensity, foot skin temperature, dorsalis pedis artery flow velocity, and F-wave occurrence rate on electromyography, were assessed at baseline and at multiple time points after surgery. Additionally, postoperative complications such as infection, electrode displacement, and lead fracture, as well as rates of new ulcer formation, amputation, and mortality, were recorded.

Results

All patients completed the 12-month follow-up period. The efficacy rate was 100% at 7 days postoperatively and 88% at 6 months, and the incidence of new ulcers at 1 year was 8%. Significant improvements in pain, foot skin temperature, and arterial flow velocity were observed within 7 days after implantation ( = 0.000), with sustained therapeutic effects lasting beyond 6 months ('=0.000). However, no further improvement in the dorsalis pedis artery flow velocity was noted with prolonged stimulation duration ("=0.459). Electromyography revealed no significant change in the F-wave occurrence rate in the early postoperative phase ( = 0.074), but a significant increase was observed at 6 months post-stimulation ('=0.003).

Conclusion

One-stage implantation of an SCS system under general anesthesia is safe and effective for managing high-risk diabetic feet. The system significantly alleviates pain, improves lower extremity perfusion, and enhances nerve conduction function. Notably, while vascular improvements occur rapidly, neurological recovery may require a longer duration of stimulation.

Keywords

Critical Limb Ischemia, Diabetic Peripheral Neuropathy, High-risk Diabetic Feet, Pain, Spinal Cord Stimulation

Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. All authors certify that no funding or commercial support was received that might constitute a conflict of interest related to this study.