Study of Biomarkers in Diabetic Chronic Wounds
A Multicenter Case Control Study of Biomarkers in Diabetic Chronic Wounds Based on Combined Multi-omics Analysis Techniques
1 other identifier
observational
930
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2022
CompletedFirst Posted
Study publicly available on registry
April 25, 2022
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedApril 16, 2024
April 1, 2024
1.4 years
April 12, 2022
April 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Bioindicators with differences among groups
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
Collect basic clinical and demographic information of participants in groups by a CRF
Through study completion, an average of 1 year
Study Arms (3)
Case group-CWD
diabetic patients with chronic wounds (CWD)
Control group 1-ND
patients without diabetes (ND)
Control group 2-NWD
diabetic patients without newly identified wound (NWD)
Interventions
collect whole blood, urine and stool samples
Eligibility Criteria
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.
You may qualify if:
- Age between 18 and 75;
- Signed the informed consent form；
- Subjects in the ND group are the healthy participants without diabetes；
- Subjects in the NWD group are the diabetic participants without newly identified wounds；
- Subjects in the CWD group are the diabetic participants with chronic wounds
You may not qualify if:
- With sever acute underlying diseases of the brain, heart, lungs, liver and/or kidney;
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yibing Wanglead
Study Sites (1)
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, 250014, China
Biospecimen
whole blood, urine, stool
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wang Yibing, Doctor
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
April 12, 2022
First Posted
April 25, 2022
Study Start
July 1, 2023
Primary Completion
December 1, 2024
Study Completion
December 1, 2025
Last Updated
April 16, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share