This clinical trial involves collecting peripheral blood, ulcer tissue, and fecal samples from diabetic ulcer patients for bioinformatics analysis to screen genetic markers significantly associated with ulcer risk and healing differences. Furthermore, multi-omics data will be integrated to establish a diabetic ulcer risk prediction model. Based on key single nucleotide polymorphisms and their regulatory pathways, potential new drug targets for promoting healing will be explored, providing a genetic basis for personalized treatment.
1) Subjects who voluntarily participate in this clinical study and sign informed consent;
2) Patients with type 2 diabetes and diabetic ulcers;
3) Disease duration ≥ 10 years or age ≥ 55 years at enrollment;
4) Inpatient or outpatient who can be monitored by the same investigating team throughout the duration of the study.
1) Severe vascular occlusion or impairment;
2) Patients with congenital heart disease, aortic dissection, or other severe cardiovascular diseases;
3) Patients with ulcers caused by factors other than diabetes;
4) Patients with severe liver and kidney dysfunction or serious neurological impairment.
The study population consists of diabetic ulcer patients who visit the The First Affiliated Hospital of University of South China during the trial period and meet the inclusion/exclusion criteria.
Case-only
Prospective
Not listed
Ulcer Healing Time
Absolute Change in Ulcer Area
Absolute change in ulcer area over three years in cm2
Number of Amputation Events
Ulcer Recurrence
Number of diabetic foot ulcers with recurrence at three years
Time to Complete Wound Closure
Time to 100% wound closure utilizing Cox proportional hazards model, a statistical measure of difference of time to event (healing). The analysis will consider covariates that might influence the outcome in the trial.
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