An observational study in Diabetes Mellitus, Biomarker and Chronic Wound, sponsored by Yibing Wang. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by Yibing Wang · Observational
This study aims to discover, verify and evaluate the potential biomarkers with regard to the diagnosis, prognostic and/or prediction of diabetic chronic wounds.
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's planned enrollment of 930 is above the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Yibing Wang is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
diabetic patients with chronic wounds (CWD)
Other: collect whole blood, urine and stool samples
patients without diabetes (ND)
Other: collect whole blood, urine and stool samples
diabetic patients without newly identified wound (NWD)
Other: collect whole blood, urine and stool samples
collect whole blood, urine and stool samples
Bioindicators with differences among groups
Analysis omics results and discover candidate bioindicators that differ between groups
Time frame: 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
Time frame: Through study completion, an average of 1 year
Plan to share: No
No publications or documents are linked to this record.
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