Study of Biomarkers in Diabetic Chronic Wounds

Yibing Wang

Status: Enrolling

Conditions: Chronic Wound; Biomarker; Diabetes Mellitus

Treatments: Other: collect whole blood, urine and stool samples

Study type: Observational

Funder types: Other

Identifiers

NCT05342740

YXLL-KY-2022(013)

Details and patient eligibility

About

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

Full 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.

Enrollment: 930 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

930 participants in 3 patient groups

Case group-CWD

Description:

diabetic patients with chronic wounds (CWD)

Treatment:

Other: collect whole blood, urine and stool samples

Control group 1-ND

Description:

patients without diabetes (ND)

Treatment:

Other: collect whole blood, urine and stool samples

Control group 2-NWD

Description:

diabetic patients without newly identified wound (NWD)

Treatment:

Other: collect whole blood, urine and stool samples