Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
930 participants
OBSERVATIONAL
2023-07-01
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case group-CWD
diabetic patients with chronic wounds (CWD)
collect whole blood, urine and stool samples
collect whole blood, urine and stool samples
Control group 1-ND
patients without diabetes (ND)
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)
collect whole blood, urine and stool samples
collect whole blood, urine and stool samples
Interventions
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collect whole blood, urine and stool samples
collect whole blood, urine and stool samples
Eligibility Criteria
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Inclusion Criteria
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
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;
18 Years
75 Years
ALL
Yes
Sponsors
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Yibing Wang
OTHER
Responsible Party
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Yibing Wang
professor
Principal Investigators
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Wang Yibing, Doctor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Locations
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The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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YXLL-KY-2022(013)
Identifier Type: -
Identifier Source: org_study_id
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