Identifying biomarkers for diabetic chronic wounds
A Multicenter Case Control Study of Biomarkers in Diabetic Chronic Wounds Based on Combined Multi-omics Analysis Techniques
This study is trying to find specific markers in the blood that can help doctors understand and predict how diabetic patients with chronic wounds will heal.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 930 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Qianfoshan Hospital Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT05342740 on ClinicalTrials.gov |
What this trial studies
This observational study aims to discover, verify, and evaluate potential biomarkers related to the diagnosis and prognosis of diabetic chronic wounds. It will be conducted in three stages: first, collecting clinical data and biological samples from diabetic patients with chronic wounds, those without newly identified wounds, and healthy individuals. The second stage will expand the sample size to verify the differences in candidate bioindicators identified in the first stage. Finally, the third stage will assess the value of these bioindicators as biomarkers in diabetic patients with chronic wounds.
Who should consider this trial
Good fit: Ideal candidates include diabetic patients aged 18 to 75 with chronic wounds or without newly identified wounds, as well as healthy individuals without diabetes.
Not a fit: Patients with severe acute underlying diseases or conditions affecting wound healing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early diagnosis and treatment strategies for diabetic chronic wounds.
How similar studies have performed: While similar studies have explored biomarkers in chronic wounds, this specific approach is novel and aims to provide new insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age between 18 and 75; 2. Signed the informed consent form； 3. Subjects in the ND group are the healthy participants without diabetes； 4. Subjects in the NWD group are the diabetic participants without newly identified wounds； 5. Subjects in the CWD group are the diabetic participants with chronic wounds Exclusion Criteria: 1. With sever acute underlying diseases of the brain, heart, lungs, liver and/or kidney; 2. No diabetes but combined with lower limb arterial stenosis, occlusion or other conditions affecting wound healing or other causes of wounds such as varicose veins in the lower limbs; 3. Special exclusion criteria for blood, urine and stool samples taking.
Where this trial is running
Jinan, Shandong
- The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital — Jinan, Shandong, China (Recruiting)
Study contacts
- Principal investigator: Wang Yibing, Doctor — The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
- Study coordinator: Wang Yibing, Doctor
- Email: wyb0616@163.com
- Phone: +86-0531-89268253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.