diabetic foot ulcer
Conditions
Interventions
Experimental group:Periosteal distraction surgery combined with standard comprehensive treatment
Control group:Simple standard comprehensive treatment
Sponsors
Special Project for Research and Transformation of Clinical Medicine in Anhui Province
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age > 18 years and = 50% tortuosity or occlusion in the inflow tract (either femoral artery or iliac artery). Vascular ultrasound or CTA or DSA shows that at least one autologous vessel in the distal lower leg is unobstructed (either anterior tibial artery, posterior tibial artery, or peroneal artery); 6. The patient is conscious, communicates smoothly, has the ability of informed consent and other autonomous behaviors. The patient understands the purpose of the study, voluntarily participates and signs the informed consent form, understands and accepts the duration of the study, and is able and willing to comply with all requirements.
Exclusion criteria
Exclusion criteria: 1. Include other diseases that may cause difficulties in the research or significantly shorten the expected lifespan of patients, such as malignant tumors, etc.; 2. Acute diabetic ketoacidosis during the acute stage; 3. Those who need to be admitted to the intensive care unit for treatment due to concurrent diseases or after surgery; 4. Those with severe systemic infections, coagulation dysfunction and other surgical contraindications, or those with poor general condition and unable to tolerate the surgery; 5. CTA shows that the arteries below the knee are narrowed or occluded, and there is no autologous blood supply from the distal end of the limb to the ankle joint and beyond, that is, the anterior tibial artery, posterior tibial artery and peroneal artery are all occluded; 6. Those who cannot follow the doctor's instructions to adjust the periosteal distraction device during the operation and withdraw halfway.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete ulcer healing rate at 6 months (24 weeks) postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ulcer healing time;WIFI tier changes;VAS pain score;Ankle-brachial index (ABI);Lower extremity vascular ultrasound hemodynamic parameters;Toe capillary refill time;Neurosensory examination of diabetic foot;Amputation rate within 6 months after surgery;Barthel Index; | — |
Countries
China
Contacts
Public ContactQiu Le
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed