Diabetic foot
Conditions
Interventions
Experimental group:Basic treatment+pentoxifylline
Control group:Basic treatment
Sponsors
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 80 years old; 2) Type 2 diabetic patients with HbA1c <=8%; 3) Meet the 2019 IWGDF definition of high-risk foot and have a history of foot ulcers or lower limb amputation; 4) Patients with foot ulcer healed within 2 weeks after foot ulcer healed; 5) Lower extremity mild to moderate ischemia, the ratio of ankle artery to brachial artery blood pressure ABI 0.4 to 0.9; 6) Unconscious disorder, no aphasia syndrome, can take oral medicine; 7) Good compliance; 8) Informed consent signed by the patient or his/her family members and indicated the date.
Exclusion criteria
Exclusion criteria: 1) Pregnant women or lactating women, or women of childbearing age who do not use contraception; 2) Patients allergic to pentoxifylline or methylxanthine 3) diabetes mellitus with acute complications; 4) Severe abnormal foot pressure, foot deformity, or by the judgment of the researchers, the patient was pseudounion; 5) Malnutrition, hemoglobin =180 and / or diastolic blood pressure >=110 mmHg; 7) Patients with severe primary diseases such as heart, liver, kidney and hematopoietic system, and patients with contraindications to pentoxifylline, including acute myocardial infarction, severe coronary atherosclerosis, advanced liver cancer, end-stage renal disease, leukemia, and patients with ALT >=2.5 ULN, AST >=2.5 ULN, Cre >=1.5 ULN; 8) Patients with recent intracranial hemorrhage, recent retinal hemorrhage and other bleeding history or bleeding tendency; 9) Alcoholics or drug abusers; 10) Expected survival of less than 3 years; 11) The investigator considers the subject to be at potential risk or have any other factors that may disturb the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate of diabetic foot ulcer; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical symptoms improvement and health economics of diabetic foot patients; | — |
Countries
China
Contacts
Public ContactShang Ju
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Outcome results
None listed