Study of Biomarkers in Diabetic Chronic Wounds

April 15, 2024 updated by: Yibing Wang

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

930

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wang Yibing, Doctor
  • Phone Number: +86-0531-89268253
  • Email: wyb0616@163.com

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250014
        • Recruiting
        • The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Participants are required to complete a structured questionnaire for assessment of inclusion requirement and then divided into the CWD group, NWD group and the ND group.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioindicators with differences among groups
Time Frame: Through study completion, an average of 1 year
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
Time Frame: Through study completion, an average of 1 year
Collect basic clinical and demographic information of participants in groups by a CRF
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yibing Wang

Investigators

  • Principal Investigator: Wang Yibing, Doctor, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YXLL-KY-2022(013)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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