An observational study in Painful Diabetic Peripheral Neuropathy and Diabetes Complication, sponsored by Qilu Hospital of Shandong University. Recruiting at 4 sites in China. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Qilu Hospital of Shandong University · Observational
Diabetic peripheral neuropathy (DPN) is one of the most common chronic complications of diabetes mellitus and a major cause of lower extremity pain, numbness, sensory loss, balance disturbance, diabetic foot ulcer and amputation. Painful diabetic peripheral neuropathy (PDPN) is characterized by burning, stabbing or electric-shock pain, accompanied by numbness, paresthesia and sleep disturbance. Current treatments including glycemic control, neurotrophic agents and analgesics such as pregabalin and duloxetine only provide limited pain relief with adverse effects, and cannot effectively improve numbness or restore nerve function.
Secondary peripheral nerve entrapment induced by nerve edema contributes to the progression of DPN. Peripheral nerve decompression can relieve nerve compression, improve nerve blood supply and alleviate pain and numbness, and reduce the risk of foot ulcer and amputation. However, numbness may not be fully relieved in some patients after decompression alone, due to chronic nerve injury. Peripheral nerve stimulation (PNS), a targeted neuromodulation technique, can modulate abnormal nerve discharge and reduce peripheral sensitization, which may further improve pain and sensory abnormalities. To date, there are limited studies evaluating combined peripheral nerve decompression plus PNS for PDPN.
This study aims to evaluate the safety and efficacy of combined peripheral nerve decompression and peripheral nerve stimulation compared with peripheral nerve decompression alone in patients with painful diabetic peripheral neuropathy. The primary objective is to explore whether the combined therapy yields superior pain relief and recovery of nerve function, to provide new clinical evidence for individualized treatment of PDPN.
Diabetic peripheral neuropathy (DPN) represents one of the most prevalent chronic complications of diabetes mellitus, and it is a major contributor to lower-extremity pain, numbness, sensory loss, balance impairment, diabetic foot ulceration and lower limb amputation. Among patients with DPN, painful diabetic peripheral neuropathy (PDPN) manifests as burning, stabbing or electric-shock-like neuropathic pain, frequently accompanied by numbness, paresthesia and sleep disturbance. Current guideline-recommended treatments for PDPN mainly include glycemic control, neurotrophic support and symptomatic analgesic medications such as pregabalin and duloxetine. However, these drugs only provide limited pain relief and carry adverse reactions including dizziness, somnolence, gastrointestinal discomfort and liver function injury. Moreover, pharmacotherapy shows minimal effect on improving numbness or restoring damaged peripheral nerve function, resulting in unsatisfactory overall clinical outcomes.
Growing evidence indicates that the pathogenesis of DPN involves not only metabolic disturbance, oxidative stress and microvascular injury, but also secondary peripheral nerve entrapment caused by nerve edema. Under hyperglycemic conditions in diabetes, edematous peripheral nerves are more vulnerable to compression at physiological narrow anatomical sites such as the fibular tunnel and tarsal tunnel, which triggers pain and sensory abnormalities. Peripheral nerve decompression surgery is designed to release nerve compression, improve nerve blood perfusion and axoplasmic transport, thereby preserving nerve function and alleviating symptoms.
Peripheral nerve decompression has been widely applied in clinical practice for DPN and demonstrated favorable therapeutic effects. This surgical procedure can relieve pain, numbness and cold sensation in most DPN patients, and reduce the incidence of neuropathic foot ulcers and amputation risk. Published randomized controlled studies have confirmed that peripheral nerve decompression achieves superior pain reduction compared with pharmacotherapy. Nevertheless, our clinical observations reveal that some patients obtain obvious relief of pain and coldness after decompression alone, while numbness remains only partially improved. This suggests that decompression surgery alone may be insufficient to fully reverse sensory abnormalities caused by chronic nerve injury.
Neuromodulation technology has brought new therapeutic strategies for refractory DPN. Spinal cord stimulation (SCS) has proven effective for refractory PDPN, and 10 kHz SCS can substantially reduce pain and improve nerve function in selected patients. Compared with SCS, peripheral nerve stimulation (PNS) provides more targeted neuromodulation by acting directly on lesioned peripheral nerves. PNS works by modulating abnormal nerve firing, improving local microcirculation and reducing peripheral nerve sensitization, which may relieve both pain and paresthesia. Currently, clinical research on PNS for PDPN remains scarce, and no published studies have evaluated combined peripheral nerve decompression plus PNS for PDPN.
In our clinical practice, we observed that PDPN patients receiving combined peripheral nerve decompression and PNS achieved more than 90% pain relief together with marked improvement in numbness, which was better than the outcomes of decompression surgery alone. This clinical finding implies that adding PNS after nerve decompression may facilitate faster recovery of peripheral nerve function.
This is a comparative clinical study enrolling patients diagnosed with painful diabetic peripheral neuropathy. Participants will be assigned to either the combined treatment group (peripheral nerve decompression plus peripheral nerve stimulation) or the control group (peripheral nerve decompression alone). The primary purpose is to evaluate the safety and efficacy of the combined intervention. We will compare the two groups in pain relief and nerve function recovery to identify the clinical advantages of combined therapy. The findings of this study are expected to generate new evidence to support individualized treatment strategies for patients with DPN and provide valuable real-world clinical evidence for this combined surgical and neuromodulation approach.
267 studies on the registry are indexed under Diabetes Complications; 54 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 84 observational studies indexed under Diabetes Complications.
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This study enrolls patients with painful diabetic peripheral neuropathy (PDPN) who received surgical treatment in the neurosurgery departments of four participating medical centers. All enrolled patients were newly diagnosed with symptomatic painful diabetic peripheral neuropathy and underwent lower extremity peripheral nerve decompression combined with peripheral nerve stimulation (PNS) lead implantation for the first time during the study period from January 1, 2025 to May 31, 2026.
The study population consists of adult patients with pain-predominant diabetic peripheral neuropathy with complete electronic medical record data. Patients with a history of previous peripheral nerve decompression surgery, severe cardiac, hepatic, renal or immune system diseases, or severely missing clinical data are excluded.
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Exclusion Criteria:
From January 1, 2025 to May 31, 2026, patients with painful diabetic peripheral neuropathy who underwent peripheral nerve decompression combined with peripheral nerve electrical stimulation in the neurosurgery departments of four hospitals: Qilu Hospital of Shandong University, Tangdu Hospital of the Air Force Medical University, Army Specialized Medical Center of the Army Medical University (Daping Hospital), and the First People's Hospital of Hangzhou Affiliated to Westlake University
From January 1, 2025 to May 31, 2026, patients with painful diabetic peripheral neuropathy who underwent peripheral nerve decompression in the neurosurgery departments of four hospitals: Qilu Hospital of Shandong University, Tangdu Hospital of the Air Force Medical University, Army Specialized Medical Center of the Army Medical University (Daping Hospital), and the First People's Hospital of Hangzhou Affiliated to Westlake University
Change in Toronto Clinical Scoring System (TCSS) total score from baseline to 3 months after surgery
Change in total score of the Toronto Clinical Scoring System (TCSS) measured at 3 months after surgery relative to baseline. Full scale name: Toronto Clinical Scoring System Scale range: Minimum score = 0, Maximum score = 19 Interpretation: Higher total score indicates more severe diabetic peripheral neuropathy. Lower total score indicates less severe neuropathy.
Time frame: 3 months after surgery
Plantar Temperature
Bilateral plantar temperature measured before PNS activation on postoperative day 1.
Time frame: Postoperative day 1
Percentage Change in Neuropathic Symptom Score at Postoperative Day 1
Percentage change in neuropathic symptom score assessed one day after surgery relative to baseline.
Time frame: Postoperative day 1
Stable Minimum Bilateral Plantar Temperature After One-week PNS Stimulation
The minimum stable bilateral plantar temperature recorded before electrode removal after one week of peripheral nerve stimulation.
Time frame: One week after PNS stimulation (before electrode removal)
Percentage Change in Diabetic Neuropathic Symptom Score Before Electrode Removal
Percentage change in diabetic neuropathic symptom score assessed before electrode removal after one week of continuous PNS stimulation, relative to baseline.
Time frame: One week after PNS stimulation
Diabetic Foot Risk Status at 3 Months Postoperatively
Comprehensive assessment of diabetic foot risk indicators at 3 months after surgery.
Time frame: 3 months after operation
Change in Lower Limb Nerve Conduction Velocity Measured by Electromyography at 3 Months Postoperatively
Change in lower limb nerve conduction velocity detected by electromyography at 3 months after surgery.
Time frame: 3 months after operation
Status of Neurotrophic Agent Use at 3 Months Postoperatively
Changes in the use and dosage of neurotrophic drugs at 3 months after surgery.
Time frame: 3 months after operation
Status of Hypoglycemic Agent Use at 3 Months Postoperatively
Changes in the use and dosage of hypoglycemic agents at 3 months after surgery.
Time frame: 3 months after operation
Status of Analgesic Medication Use at 3 Months Postoperatively
Changes in the use and dosage of analgesic medications at 3 months after surgery.
Time frame: 3 months after operation
Participant-reported Satisfaction Level for Combined Surgical Treatment at 3 Months Postoperatively
Participant self-reported satisfaction level regarding the combined surgical treatment at 3 months after surgery.
Time frame: 3 months after operation
Plan to share: Yes — All collected IPD
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Beginning1 year after publication with no end date
Access criteria: The individual participant data (IPD) and supporting information are available from the corresponding author upon reasonable request via email. Access will be provided to researchers with a scientifically sound proposal and for non-commercial purposes, in compliance with ethical guidelines.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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