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Construction and Clinical Application of a Multimodal Evaluation System for Minimally Invasive Neurolysis in the Treatment of Painful Diabetic Peripheral Neuropathy

Construction and Clinical Application of a Multimodal Evaluation System for Minimally Invasive Neurolysis in the Treatment of Painful Diabetic Peripheral Neuropathy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106908
Enrollment
Unknown
Registered
2025-07-31
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Peripheral Neuropathy with Pain

Interventions

Control Group:Conservative treatment with conventional medication
Surgical group:Microendoscopic Decompression Surgery

Sponsors

Ankang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Meets the diagnostic criteria of PDPN; 2.Age 18-75 years; 3.The course of PDPN in both lower extremities is more than 6 months and less than 10 years. 4.The patient or family member has agreed to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Combine severe organ dysfunction (including: liver, kidney, respiratory, circulatory, alcoholic, uremic diseases, etc.) or other diseases that the investigator considers affect the safety evaluation. 2.Diagnosed with malignant tumors or other factors leading to a life expectancy of less than 1 year. 3.Severe lower limb ulcers, dry gangrene, requiring amputation or already amputated. 4.Severe stenosis of lower limb vessels was combined, resulting in limping and ulcers of the lower limbs, and vascular recanalization therapy was required. 5.Merging severe cervical, lumbar disc herniation or lumbar degenerative changes; 6.There are contraindications for surgery or anesthesia. 7.The subject refused to accept follow-up.

Design outcomes

Primary

MeasureTime frame
diabetic neuralgia 4,DN4;Visual Analogue Scale for Pain;Two-point Discrimination;Tinel's sign;Toronto clinical scoring system,TCSS;

Secondary

MeasureTime frame
Pittsburgh sleep quality index,PSQI;The cross-sectional area of the nerve compressed;

Countries

China

Contacts

Public ContactLiu Feng

Ankang Central Hospital

fengge6095@163.com+86 182 9152 4632

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026