Genetic Markers of Diabetic Ulcers and Personalized Treatment Targets Research
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diabetic Ulcers. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Investigation of Genetic Markers in Diabetic Ulcers and Their Role in Personalized Treatment Targeting
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.
Primary outcome measures
- Ulcer Healing Time [Time frame: Three years]
Secondary outcome measures (7)
- Absolute Change in Ulcer Area [Time frame: Three years]
- Number of Amputation Events [Time frame: Three years]
- Ulcer Recurrence [Time frame: Three years]
- Time to Complete Wound Closure [Time frame: Three years or wound closure]
- Number of Foot Infections [Time frame: Three years]
- Quality of Life Assessment [Time frame: Three years]
- Length of Stay [Time frame: Three years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- The First Affiliated Hospital of University of South China — Hengyang
Identifiers
NCT: NCT06979037 · NHFY20240506