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Evaluation of the effect of lateral tibial bone transfer combined with neurolysis in the treatment of Wagner grade 3~4 diabetes foot ulcer

Evaluation of the effect of lateral tibial bone transfer combined with neurolysis in the treatment of Wagner grade 3~4 diabetes foot ulcer and study on mechanism

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067781
Enrollment
Unknown
Registered
2023-01-23
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Diabetes foot ulcer combined with peripheral nerve and vascular diseases

Interventions

Combined treatment group:TTT technology combined with neurolysis
Group of transverse tibial bone transfer:Transverse bone transfer of tibia

Sponsors

Affiliated Hospital of Zunyi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. 18-70 years old, male or female; 2. Meet the diagnostic criteria for type 2 diabetes (according to the WHO diagnostic criteria for diabetes in 1999): diabetes symptoms plus plasma glucose >= 11.1mmol/L (200mg / dL) at any time, or fasting plasma glucose level (FPG) >= 7.0mmol/L (126mg / dL), or 2-hour blood glucose value (2hPG) in oral glucose tolerance test (OGTT) >= 11.1mmol/L (200mg / dL); 3. Patients with Wagner grade 3-4 diabetes foot: Grade 3 deep ulcer with abscess, osteomyelitis or sepsis; Grade 4 local gangrene (toe, heel or forefoot dorsum), characterized by ischemic gangrene, usually accompanied by neuropathy; 4. Strong willingness to save limbs and good condition of popliteal artery of affected limbs; 5. There were no serious complications and other serious diseases, and there was no absolute surgical contraindication; 6. Patients were informed and voluntarily participated in this study.

Exclusion criteria

Exclusion criteria: 1. The popliteal artery of the affected limb was completely blocked and no collateral circulation was established; 2. Patients with arteriovenous vascular diseases such as venous embolism and lymphangitis; 3. Patients with severe dysfunction of heart, lung, liver, kidney and other organs; 4. Acute complications of diabetes, such as hypertonic coma of diabetes, ketosis and ketoacidosis of diabetes, lactic acidosis, etc; 5. Patients with malignant tumor; 6. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Quantitative sensory testing, QST;visual analog scale, VAS;Neuroelectrophysiological examination;Inflammation index;extremity blood flow assessment;Wound healing time;Incidence of amputation;—

Secondary

MeasureTime frame
Length of stay in hospital;—

Countries

China

Contacts

Public ContactChang Shusen

Affiliated Hospital of Zunyi Medical University

13511848567@163.com+86 135 1184 8567

Outcome results

None listed

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