Lower limb rehabilitation training for patients with diabetes and lower extremity arterial disease (LEAD) Nutritional, Metabolic, Endocrine
Conditions
Interventions
Both groups receive standard treatment: blood glucose control (liraglutide injection, Novo Nordisk (China)), lipid-lowering therapy (atorvastatin, Qilu Pharmaceutical), depressor (verapamil hydrochlor
Sponsors
The Second Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meeting the diagnostic criteria for DM and LEAD 2. Confirmed to have Fontaine stage I to IV LEAD (stage I: asymptomatic; stage IIa: mild intermittent claudication; stage IIb: moderate to severe intermittent claudication; stage III: ischemic rest pain; stage IV: ischemic ulcer or gangrene) 3. Age between 18 and 80 years 4. Clear consciousness and ability to cooperate with treatment 5. Disease duration within one year 6. Provision of signed informed consent
Exclusion criteria
Exclusion criteria: 1. Severe cardiac, pulmonary, hepatic, or renal insufficiency 2. Recent history of fractures and chronic orthopedic diseases 3. Severe carbon dioxide retention 4. Known malignant diseases and tumor history 5. Coexisting peripheral vascular disease 6. Lack of cooperation or no provision of signed informed consent from the patient or his/her family members
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain is measured using a 10 cm sliding ruler (VAS score) at baseline and after treatment 2. Barthel Index is measured using the Barthel Index rating scale at baseline and after treatment 3. Blood glucose levels are measured using a fingerstick test in the fasting state in the early morning and 2 hours after breakfast at baseline and after treatment 4. Levels of TC, TG, HDL-C, LDL-C, IL-6, CRP, and HCY are measured using a fully automated biochemical analyzer from fasting venous blood samples at baseline and after treatment 5. ABI index is measured using a Doppler stethoscope at baseline and after treatment 6. Partial pressure of oxygen within tissue microcirculation (TcPO2) is measured using a TcPO2 test at baseline and after treatment 7. DPA flow velocity on the affected side is measured using color Doppler ultrasound at baseline and after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| The general characteristics of the patients were measured using a questionnaire at baseline | — |
Countries
China
Contacts
Public ContactHongling Li
Outcome results
None listed