Painful Diabetic Peripheral NeuropathyNCT07911410
Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy
An observational study of Painful Diabetic Peripheral Neuropathy and Diabetes Complication, run by Qilu Hospital of Shandong University at 4 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Painful Diabetic Peripheral Neuropathy, Diabetes Complication
- How many people
- 100 participants
- Where
- 4 sitesChina
- Study dates
- 15 Oct 2026to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Patients diagnosed with DPN who underwent lower extremity peripheral nerve decompression combined with PNS lead implantation in the Department of Neurosurgery of four hospitals (Qilu Hospital of Shandong University, Tangdu Hospital of Air Force Military Medical University, Army Medical Center of Army Medical University (Daping Hospital), and the First People's Hospital of Hangzhou Affiliated to Westlake University) between January 1, 2025 and May 31, 2026.
- Patients with a confirmed diagnosis of diabetic peripheral neuropathy with pain as the predominant symptom.
- Patients receiving lower extremity peripheral nerve decompression combined with PNS lead implantation for the first time.
- Patients with complete electronic medical record data.
Who cannot join
- Patients who have previously undergone lower extremity peripheral nerve decompression surgery.
- Patients with severe comorbidities, including severe cardiac disease, hepatic or renal insufficiency, and immune system deficiency.
- Patients with substantial missing data.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Department of Neurosurgery,Daping Hospital of Army Medical University
Chongqing, 40042
Tian zun Li, MD, +86 15683213229, 903495394@99.com
- Recruiting
Department of Neurosurgery, Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310000
Yuanfeng Du, M.D，Ph.D, +86 15988849964
- Recruiting
Qilu hospital
Jinan, Shandong, 250012
- Recruiting
Department of Neurosurgery, Tang-Du Hospital
Xi’an, Shanxi, 710038
Bao Wang, M.D，Ph.D, +86 18092307582, bob.kane@163.com
About this study
Official title: Study on the Safety and Therapeutic Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for the Treatment of Painful Diabetic Peripheral Neuropathy
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.
Read the detailed description
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.
- Keywords
- Painful Diabetic Peripheral Neuropathy, Peripheral nerve decompression, Peripheral nerve stimulation
- Medical subject headings
- Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with painful DPN receiving peripheral nerve decompression plus peripheral nerve stimulation | 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 | |
| Patients with painful DPN receiving peripheral nerve decompression | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after surgery
Secondary outcomes (10)
Plantar Temperature
Bilateral plantar temperature measured before PNS activation on postoperative day 1.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start15 Oct 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Painful Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Daping Hospital of Army Medical University, Tang-Du Hospital, First People's Hospital of Hangzhou
- Responsible party
- Sponsor
- Investigators
- Ning Yang, doctor, Principal investigator, Department of Neurosurgery, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911410
- Sponsor's protocol ID
- KYLL-2026-08-049
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Publications
Raghu ALB, Parker T, Aziz TZ, Green AL, Hadjipavlou G, Rea R, FitzGerald JJ. Invasive Electrical Neuromodulation for the Treatment of Painful Diabetic Neuropathy: Systematic Review and Meta-Analysis. Neuromodulation. 2021 Jan;24(1):13-21. doi: 10.1111/ner.13216. Epub 2020 Jun 26.
PubMed 32588933Petersen EA, Stauss TG, Scowcroft JA, Brooks ES, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu J, Yu C, Nairizi A, Patterson DG, Tsoulfas KC, Creamer MJ, Galan V, Bundschu RH, Paul CA, Mehta ND, Choi H, Sayed D, Lad SP, DiBenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ, Israel AF, Chang P, Wu PW, Gekht G, Argoff CE, Nasr CE, Taylor RS, Subbaroyan J, Gliner BE, Caraway DL, Mekhail NA. Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy: A Randomized Clinical Trial. JAMA Neurol. 2021 Jun 1;78(6):687-698. doi: 10.1001/jamaneurol.2021.0538.
PubMed 33818600Chaudhry V, Russell J, Belzberg A. Decompressive surgery of lower limbs for symmetrical diabetic peripheral neuropathy. Cochrane Database Syst Rev. 2008 Jul 16;2008(3):CD006152. doi: 10.1002/14651858.CD006152.pub2.
PubMed 18646138Best TJ, Best CA, Best AA, Fera LA. Surgical peripheral nerve decompression for the treatment of painful diabetic neuropathy of the foot - A level 1 pragmatic randomized controlled trial. Diabetes Res Clin Pract. 2019 Jan;147:149-156. doi: 10.1016/j.diabres.2018.08.002. Epub 2018 Aug 4.
PubMed 30081106Liao C, Zhang W, Yang M, Ma Q, Li G, Zhong W. Surgical decompression of painful diabetic peripheral neuropathy: the role of pain distribution. PLoS One. 2014 Oct 7;9(10):e109827. doi: 10.1371/journal.pone.0109827. eCollection 2014.
PubMed 25290338Aszmann O, Tassler PL, Dellon AL. Changing the natural history of diabetic neuropathy: incidence of ulcer/amputation in the contralateral limb of patients with a unilateral nerve decompression procedure. Ann Plast Surg. 2004 Dec;53(6):517-22. doi: 10.1097/01.sap.0000143605.60384.4e.
PubMed 15602245Dellon AL. Treatment of symptomatic diabetic neuropathy by surgical decompression of multiple peripheral nerves. Plast Reconstr Surg. 1992 Apr;89(4):689-97; discussion 698-9.
PubMed 1546082Price R, Smith D, Franklin G, Gronseth G, Pignone M, David WS, Armon C, Perkins BA, Bril V, Rae-Grant A, Halperin J, Licking N, O'Brien MD, Wessels SR, MacGregor LC, Fink K, Harkless LB, Colbert L, Callaghan BC. Oral and Topical Treatment of Painful Diabetic Polyneuropathy: Practice Guideline Update Summary: Report of the AAN Guideline Subcommittee. Neurology. 2022 Jan 4;98(1):31-43. doi: 10.1212/WNL.0000000000013038.
PubMed 34965987Selvarajah D, Kar D, Khunti K, Davies MJ, Scott AR, Walker J, Tesfaye S. Diabetic peripheral neuropathy: advances in diagnosis and strategies for screening and early intervention. Lancet Diabetes Endocrinol. 2019 Dec;7(12):938-948. doi: 10.1016/S2213-8587(19)30081-6. Epub 2019 Oct 14.
PubMed 31624024Feldman EL, Nave KA, Jensen TS, Bennett DLH. New Horizons in Diabetic Neuropathy: Mechanisms, Bioenergetics, and Pain. Neuron. 2017 Mar 22;93(6):1296-1313. doi: 10.1016/j.neuron.2017.02.005.
PubMed 28334605Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available.
PubMed 27999003Callaghan BC, Price RS, Feldman EL. Distal Symmetric Polyneuropathy: A Review. JAMA. 2015 Nov 24;314(20):2172-81. doi: 10.1001/jama.2015.13611.
PubMed 26599185
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Safety and Therapeutic Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for the Treatment of Painful Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07911410
- Acronym / sponsor ID
- KYLL-2026-08-049
- Keywords
- Painful Diabetic Peripheral Neuropathy, Peripheral nerve decompression, Peripheral nerve stimulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Daping Hospital of Army Medical University, Tang-Du Hospital, First People's Hospital of Hangzhou
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with painful DPN receiving peripheral nerve decompression plus peripheral nerve stimulation | – | –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 |
| Patients with painful DPN receiving peripheral nerve decompression | – | –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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Patients diagnosed with DPN who underwent lower extremity peripheral nerve decompression combined with PNS lead implantation in the Department of Neurosurgery of four hospitals (Qilu Hospital of Shandong University, Tangdu Hospital of Air Force Military Medical University, Army Medical Center of Army Medical University (Daping Hospital), and the First People's Hospital of Hangzhou Affiliated to Westlake University) between January 1, 2025 and May 31, 2026.
- Patients with a confirmed diagnosis of diabetic peripheral neuropathy with pain as the predominant symptom.
- Patients receiving lower extremity peripheral nerve decompression combined with PNS lead implantation for the first time.
- Patients with complete electronic medical record data.
Key exclusion criteria (3 listed)
- Patients who have previously undergone lower extremity peripheral nerve decompression surgery.
- Patients with severe comorbidities, including severe cardiac disease, hepatic or renal insufficiency, and immune system deficiency.
- Patients with substantial missing data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Toronto Clinical Scoring System (TCSS) total score from baseline to 3 months after surgery
Time frame: 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.
10 secondary outcomes
Plantar Temperature
Time frame: Postoperative day 1
Percentage Change in Neuropathic Symptom Score at Postoperative Day 1
Time frame: Postoperative day 1
Stable Minimum Bilateral Plantar Temperature After One-week PNS Stimulation
Time frame: One week after PNS stimulation (before electrode removal)
Percentage Change in Diabetic Neuropathic Symptom Score Before Electrode Removal
Time frame: One week after PNS stimulation
Diabetic Foot Risk Status at 3 Months Postoperatively
Time frame: 3 months after operation
Change in Lower Limb Nerve Conduction Velocity Measured by Electromyography at 3 Months Postoperatively
Time frame: 3 months after operation
Status of Neurotrophic Agent Use at 3 Months Postoperatively
Time frame: 3 months after operation
Status of Hypoglycemic Agent Use at 3 Months Postoperatively
Time frame: 3 months after operation
Status of Analgesic Medication Use at 3 Months Postoperatively
Time frame: 3 months after operation
Participant-reported Satisfaction Level for Combined Surgical Treatment at 3 Months Postoperatively
Time frame: 3 months after operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 32588933Raghu ALB, Parker T, Aziz TZ, Green AL, Hadjipavlou G, Rea R, FitzGerald JJ. Invasive Electrical Neuromodulation for the Treatment of Painful Diabetic Neuropathy: Systematic Review and Meta-Analysis. Neuromodulation. 2021 Jan;24(1):13-21. doi: 10.1111/ner.13216. Epub 2020 Jun 26.
- Background: PubMed 33818600Petersen EA, Stauss TG, Scowcroft JA, Brooks ES, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu J, Yu C, Nairizi A, Patterson DG, Tsoulfas KC, Creamer MJ, Galan V, Bundschu RH, Paul CA, Mehta ND, Choi H, Sayed D, Lad SP, DiBenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ, Israel AF, Chang P, Wu PW, Gekht G, Argoff CE, Nasr CE, Taylor RS, Subbaroyan J, Gliner BE, Caraway DL, Mekhail NA. Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy: A Randomized Clinical Trial. JAMA Neurol. 2021 Jun 1;78(6):687-698. doi: 10.1001/jamaneurol.2021.0538.
- Background: PubMed 18646138Chaudhry V, Russell J, Belzberg A. Decompressive surgery of lower limbs for symmetrical diabetic peripheral neuropathy. Cochrane Database Syst Rev. 2008 Jul 16;2008(3):CD006152. doi: 10.1002/14651858.CD006152.pub2.
- Background: PubMed 30081106Best TJ, Best CA, Best AA, Fera LA. Surgical peripheral nerve decompression for the treatment of painful diabetic neuropathy of the foot - A level 1 pragmatic randomized controlled trial. Diabetes Res Clin Pract. 2019 Jan;147:149-156. doi: 10.1016/j.diabres.2018.08.002. Epub 2018 Aug 4.
- Background: PubMed 25290338Liao C, Zhang W, Yang M, Ma Q, Li G, Zhong W. Surgical decompression of painful diabetic peripheral neuropathy: the role of pain distribution. PLoS One. 2014 Oct 7;9(10):e109827. doi: 10.1371/journal.pone.0109827. eCollection 2014.
- Background: PubMed 15602245Aszmann O, Tassler PL, Dellon AL. Changing the natural history of diabetic neuropathy: incidence of ulcer/amputation in the contralateral limb of patients with a unilateral nerve decompression procedure. Ann Plast Surg. 2004 Dec;53(6):517-22. doi: 10.1097/01.sap.0000143605.60384.4e.
- Background: PubMed 1546082Dellon AL. Treatment of symptomatic diabetic neuropathy by surgical decompression of multiple peripheral nerves. Plast Reconstr Surg. 1992 Apr;89(4):689-97; discussion 698-9.
- Background: PubMed 34965987Price R, Smith D, Franklin G, Gronseth G, Pignone M, David WS, Armon C, Perkins BA, Bril V, Rae-Grant A, Halperin J, Licking N, O'Brien MD, Wessels SR, MacGregor LC, Fink K, Harkless LB, Colbert L, Callaghan BC. Oral and Topical Treatment of Painful Diabetic Polyneuropathy: Practice Guideline Update Summary: Report of the AAN Guideline Subcommittee. Neurology. 2022 Jan 4;98(1):31-43. doi: 10.1212/WNL.0000000000013038.
- Background: PubMed 31624024Selvarajah D, Kar D, Khunti K, Davies MJ, Scott AR, Walker J, Tesfaye S. Diabetic peripheral neuropathy: advances in diagnosis and strategies for screening and early intervention. Lancet Diabetes Endocrinol. 2019 Dec;7(12):938-948. doi: 10.1016/S2213-8587(19)30081-6. Epub 2019 Oct 14.
- Background: PubMed 28334605Feldman EL, Nave KA, Jensen TS, Bennett DLH. New Horizons in Diabetic Neuropathy: Mechanisms, Bioenergetics, and Pain. Neuron. 2017 Mar 22;93(6):1296-1313. doi: 10.1016/j.neuron.2017.02.005.
- Background: PubMed 27999003Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available.
- Background: PubMed 26599185Callaghan BC, Price RS, Feldman EL. Distal Symmetric Polyneuropathy: A Review. JAMA. 2015 Nov 24;314(20):2172-81. doi: 10.1001/jama.2015.13611.
- Individual participant dataSharing planned: Yes. All collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ning Yang, doctor principal investigator
Department of Neurosurgery, Qilu Hospital of Shandong University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Painful Diabetic Peripheral Neuropathy and Diabetes Complication, run by Qilu Hospital of Shandong University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ning Yang, doctor (+86 18560088290, yangning@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Toronto Clinical Scoring System (TCSS) total score from baseline to 3 months after surgery (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07911410, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.