Study of Biomarkers in Diabetic Chronic Wounds

Study Overview
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Brief Summary
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This study aims to discover, verify and evaluate the potential biomarkers with regard to the diagnosis, prognostic and/or prediction of diabetic chronic wounds.

Detailed Description
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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.

Official Title
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A Multicenter Case Control Study of Biomarkers in Diabetic Chronic Wounds Based on Combined Multi-omics Analysis Techniques

Conditions
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Diabetes Mellitus, Biomarker, Chronic Wound

Intervention / Treatment
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* Other: collect whole blood, urine and stool samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 75; Signed the informed consent form； 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: With sever acute underlying diseases of the brain, heart, lungs, liver and/or kidney; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case group-CWD<br>diabetic patients with chronic wounds (CWD) | Other: collect whole blood, urine and stool samples<br>* collect whole blood, urine and stool samples<br>|
| Control group 1-ND<br>patients without diabetes (ND) | Other: collect whole blood, urine and stool samples<br>* collect whole blood, urine and stool samples<br>|
| Control group 2-NWD<br>diabetic patients without newly identified wound (NWD) | Other: collect whole blood, urine and stool samples<br>* collect whole blood, urine and stool samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioindicators with differences among groups | Analysis omics results and discover candidate bioindicators that differ between groups | Through study completion, an average of 1 year | 
| Basic clinical and demographic information of participants in groups | Collect basic clinical and demographic information of participants in groups by a CRF | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early diagnosis, chronic diabetic wound, prognostic, prediction, biomarker, muti-omics