Genetic Markers of Diabetic Ulcers and Personalized Treatment Targets Research

The First Affiliated Hospital of University of South China712 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

712

Conditions

Diabetic Ulcers

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (1)

Outcomes

Primary Outcomes

Ulcer Healing Time

Time frame: Three years

Secondary Outcomes

Absolute Change in Ulcer Area

Absolute change in ulcer area over three years in cm2

Time frame: Three years

Number of Amputation Events

Time frame: Three years

Ulcer Recurrence

Number of diabetic foot ulcers with recurrence at three years

Time frame: 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.

Time frame: Three years or wound closure

Number of Foot Infections

Time frame: Three years

Quality of Life Assessment

The Cardiff Wound Impact Schedule questionnaire to measure quality of life. Measure of well-being items from each scale are summated, physical symptoms, everyday living and social life. The items are rated for the extent of the experience and each item is given a number value. This allows the patients to weight the items included in the scale. The well-being scale is scored on a 5-point Likert scale, with response options from 'strongly agree' to 'strongly disagree'. All three scales are then transformed onto a minimum = 0 up to a maximum = 100, where a low score indicates worse, and a high score indicates better feeling of well-being.

Time frame: Three years

Length of Stay

Time frame: Three years

Genetic Markers of Diabetic Ulcers and Personalized Treatment Targets Research

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts