Study of Biomarkers in Diabetic Chronic Wounds
Study Details
Study Description
Brief Summary
This study aims to discover, verify and evaluate the potential biomarkers with regard to the diagnosis, prognostic and/or prediction of diabetic chronic wounds.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Investigators will conduct a multicenter prospective case control study consisting of three stages.
In the first stage, investigators will collect clinical data and blood, urine and stool samples from diabetic patients with chronic wound (CWD), diabetic patient without newly identified wound (NWD) and patients without diabetes (ND to discover the candidate bioindicator with differences through combined high-throughput non targeted detection.
In the second stage, investigators will expand the sample size and collect the clinical data and biological samples (blood, urine and stool) of the CWD,NWD and ND participants to verify the difference of the candidate bioindicator in the first stage by targeted technologies.
In the third stage, investigators will collect the clinical data and biological samples (blood, urine and stool) of the CWD and NWD participants to evaluate the value of these candidate bioindicators as biomarkers.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Case group-CWD diabetic patients with chronic wounds (CWD) |
Other: collect whole blood, urine and stool samples
collect whole blood, urine and stool samples
|
| Control group 1-ND patients without diabetes (ND) |
Other: collect whole blood, urine and stool samples
collect whole blood, urine and stool samples
|
| Control group 2-NWD diabetic patients without newly identified wound (NWD) |
Other: collect whole blood, urine and stool samples
collect whole blood, urine and stool samples
|
Outcome Measures
Primary Outcome Measures
- Bioindicators with differences among groups [Through study completion, an average of 1 year]
Analysis omics results and discover candidate bioindicators that differ between groups
- Basic clinical and demographic information of participants in groups [Through study completion, an average of 1 year]
Collect basic clinical and demographic information of participants in groups by a CRF
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age between 18 and 75;
-
Signed the informed consent form；
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Subjects in the ND group are the healthy participants without diabetes；
-
Subjects in the NWD group are the diabetic participants without newly identified wounds；
-
Subjects in the CWD group are the diabetic participants with chronic wounds
Exclusion Criteria:
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With sever acute underlying diseases of the brain, heart, lungs, liver and/or kidney;
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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;
-
Special exclusion criteria for blood, urine and stool samples taking.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital | Jinan | Shandong | China | 250014 |
Sponsors and Collaborators
- Yibing Wang
Investigators
- Principal Investigator: Wang Yibing, Doctor, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- YXLL-KY-2022(013)