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Evaluation of the effectiveness and safety of llizarov tibial transverse bone removal microcirculation in the treatment of diabetic foot Wagner2-4 patients A multicenter, open, randomized, positive parallel controlled clinical study

Evaluation of the effectiveness and safety of llizarov tibial transverse bone removal microcirculation in the treatment of diabetic foot Wagner2-4 patients A multicenter, open, randomized, positive parallel controlled clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17011185
Enrollment
Unknown
Registered
2017-04-19
Start date
2017-04-20
Completion date
Unknown
Last updated
2017-04-24

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

Conditions

Diabetic foot

Interventions

test group:Tibial transverse bone transport microcirculation reconstruction
Control group:Control of blood sugar, lipid, anticoagulation, anti-platelets, vasodilators and other traditional treatment

Sponsors

Department of Orthopedics, the Fifth Affiliated Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. diagnosed diabetic foot ulcers Wagner stage 2-4 patients; 2. older than 18 years old, and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. recent diabetic ketoacidosis, hyperosmolar coma or severe chronic diabetes complications and other stress conditions such as acute heart, cerebrovascular accident; 2. peripheral arterial lesions can not be more than the middle of the artery; 3. creatinine is higher than the normal upper limit of 1.5 times or serum creatinine concentration =133 umol/L (male)/124umol/L (female), such as aspartate aminotransferase or alanine aminotransferase, Or creatinine clearance <60 mL/min; 4. severe lung infection, cardiopulmonary dysfunction control poor; 5. severe hypoproteinemia (albumin levels below 30 g/L); 6. hemoglobin less than 90 g/L.

Design outcomes

Primary

MeasureTime frame
Wound healing rate;

Secondary

MeasureTime frame
Limb salvage rate;Pain VAS score;Skin temperature feeling;Vascular remodeling;Complications occur;Wagner stage improvement;Ankle brachial index;10 g nylon thread test;

Countries

China

Contacts

Public ContactYongjian Sun

Department of Orthopedics, the Fifth Affiliated Hospital of Southern Medical University

nfyysyj@163.com+86 13042038688

Outcome results

None listed

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