diabetic foot
Conditions
Interventions
Experimental group:diabetic footwear with vibration chip and merino wool
control group:routine custom-made footwear
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. aged >=18 years; 2. type 1 or type 2 diabetes mellitus; 3. decrease or loss of protective foot sensation due to/as a result of diabetic peripheral neuropathy; 4. had a healed foot ulceration in the 12 months prior to/preceding randomization.
Exclusion criteria
Exclusion criteria: 1. bilateral amputation proximal to the tarsometatarsal joint; 2. the use of walking aids that offload the foot); 3. severe lower extremity artery disease(ABI<0.4,intermittent claudication or rest pain)); 4. osteoarticular diseases unrelated to T1DM or T2DM; 5. decrease or loss of vision that is difficult to treat or correct; 6. Unstable cardiovascular disease or unstable ischemic cerebrovascular disease; 7. severe renal dysfunction or severe liver dysfunction; 8. malignant tumor; 9. severe illness that would make 24-month survival unlikely (as judged by the patients physician); 10. Pregnancy or breast-feeding women; 11. Neurologic or psychiatric disease that may prevent compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ulcer recurrence rate;in-shoe plantar pressures; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood flow velocity of lower extremity;transcutaneous oxygen pressure;incidence of cardiovascular events; | — |
Countries
China
Contacts
Public ContactXingwu Ran
West China Hospital, Sichuan University
Outcome results
None listed