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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| collect whole blood, urine and stool samples | Other | collect whole blood, urine and stool samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Yibing, Doctor | Contact | +86-0531-89268253 | wyb0616@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wang Yibing, Doctor | The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital | Recruiting | Jinan | Shandong | 250014 | China |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D004194 | Disease |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D014554 | Urination |
| ID | Term |
|---|---|
| D014553 | Urinary Tract Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
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whole blood, urine, stool
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |