Study of Biomarkers in Diabetic Chronic Wounds

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05342740
• Other study ID #: YXLL-KY-2022(013)
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Qianfoshan Hospital
• Contact: Wang Yibing, Doctor
• Phone: +86-0531-89268253
• Email: wyb0616[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 930
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Biomarker
• Chronic Wound
• Diabetes Mellitus
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Yibing Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioindicators with differences among groups	Analysis omics results and discover candidate bioindicators that differ between groups	Through study completion, an average of 1 year
Primary	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