Diabetic foot-high risk foot
Conditions
Interventions
AI CARE group:Application of multi-model perception and AI care system
Control group:The control group receives standardized screening for diabetes and neurovascular complications, along with preventive management for foot diseases
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. type 2 diabetic patients with duration longer than 3 years; 2. Age 35~75 years old,male or female; 3. Presence of any one or more of the following: abnormal foot appearance, neuropathy, vasculopathy, or structural foot abnormalities; 4. Ability to proficiently use a smartphone and the intelligent management App; 5. Ability to cooperate with foot image and other information collection, uploading, and long-term regular follow-up; 6. Willingness to sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Severe cardiac insufficiency (New York Heart Association classification >= Grade 3), or renal insufficiency (SCr > 250 µmol/L or eGFR 2.5 times the upper limit of normal); 2. Severely uncontrolled hypertension: SBP > 190 mmHg and/or DBP > 100 mmHg; 3. Positive pregnancy test, or lactating women, or pregnant or childbearing-age women unwilling to take effective contraceptive measures during the study period; 4. Concurrent hematologic diseases, history of malignancy, or consumptive diseases such as tuberculosis; 5. Acute diabetic complications (e.g., diabetic ketoacidosis, hyperosmolar state, etc.); 6. Limb disability, absence, history of amputation, or limb paralysis due to cerebrovascular or other neurological diseases; 7. Psychiatric disorders, intellectual disability, or limited comprehension that prevents understanding of study requirements or cooperation with the use of smartphone App and other intelligent tools.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of new onset foot ulcer; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement Rate of Plantar Pressure and Gait Abnormalities;Patient Satisfaction with the High-Risk Foot App;Quality of Life (QoL); | — |
Countries
China
Contacts
Public ContactFang Liu
Shanghai General Hospital
Outcome results
None listed