Biomarker, Chronic Wound, Diabetes Mellitus
Conditions
Keywords
chronic diabetic wound, early diagnosis, prognostic, prediction, biomarker, muti-omics
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.
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.
Interventions
OTHERcollect whole blood, urine and stool samples
collect whole blood, urine and stool samples
Sponsors
Yibing Wang
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactWang Yibing, Doctor
Outcome results
None listed