Diabetic Ulcers
Conditions
Keywords
Diabetic Ulcers
Brief summary
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.
Interventions
None listed
Sponsors
The First Affiliated Hospital of University of South China
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ulcer Healing Time | Three years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in Ulcer Area | Three years | Absolute change in ulcer area over three years in cm2 |
| Number of Amputation Events | Three years | — |
| Ulcer Recurrence | Three years | Number of diabetic foot ulcers with recurrence at three years |
| Number of Foot Infections | Three years | — |
| Quality of Life Assessment | Three years | 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. |
| Length of Stay | Three years | — |
| Time to Complete Wound Closure | Three years or 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. |
Countries
China
Contacts
Primary ContactJiecan Zhou, Prof.
Outcome results
None listed