Study of Biomarkers in Diabetic Chronic Wounds

Recruiting

• Conditions: Diabetes Mellitus; Biomarker; Chronic Wound
• Interventions: Other: collect whole blood, urine and stool samples

• Registration Number: NCT05342740
• Lead Sponsor: Yibing Wang

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.

Study Timeline

• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-19
• Study First Posted: 2022-04-25
• Study Start: 2023-07-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 930

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group 1-ND	collect whole blood, urine and stool samples	patients without diabetes (ND)
Case group-CWD	collect whole blood, urine and stool samples	diabetic patients with chronic wounds (CWD)
Control group 2-NWD	collect whole blood, urine and stool samples	diabetic patients without newly identified wound (NWD)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital; 🇨🇳 Jinan, Shandong, China