Diabetes MellitusNCT05342740
Study of Biomarkers in Diabetic Chronic Wounds
An observational study of Diabetes Mellitus and Biomarker, run by Yibing Wang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Biomarker, Chronic Wound
- What is being tested?
- collect whole blood, urine and stool samples
- How many people
- 930 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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;
- Special exclusion criteria for blood, urine and stool samples taking.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, 250014
Wang Yibing, Doctor, +86053189268253, wyb0616@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Biomarker, Chronic Wound
- Being tested
- collect whole blood, urine and stool samples
- Keywords
- chronic diabetic wound, early diagnosis, prognostic, prediction, biomarker, muti-omics
- Medical subject headings
- Diabetes Mellitus, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collect whole blood, urine and stool samplesOther
collect whole blood, urine and stool samples
| Study group | Role | What they receive |
|---|---|---|
| Case group-CWD | diabetic patients with chronic wounds (CWD) Receives: Other: collect whole blood, urine and stool samples | |
| Control group 1-ND | patients without diabetes (ND) Receives: Other: collect whole blood, urine and stool samples | |
| Control group 2-NWD | diabetic patients without newly identified wound (NWD) Receives: Other: collect whole blood, urine and stool samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioindicators with differences among groups
Analysis omics results and discover candidate bioindicators that differ between groups
Measured: 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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Jul 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 930 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yibing Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yibing Wang, Qianfoshan Hospital
- Investigators
- Wang Yibing, Doctor, Principal investigator, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342740
- Sponsor's protocol ID
- YXLL-KY-2022(013)
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2022
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Case Control Study of Biomarkers in Diabetic Chronic Wounds Based on Combined Multi-omics Analysis Techniques
- ClinicalTrials.gov ID
- NCT05342740
- Acronym / sponsor ID
- YXLL-KY-2022(013)
- Conditions
- Diabetes Mellitus, Biomarker, Chronic Wound
- Keywords
- chronic diabetic wound, early diagnosis, prognostic, prediction, biomarker, muti-omics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 930 participants (estimated)
- Lead sponsor
- Yibing WangUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to discover, verify and evaluate the potential biomarkers with regard to the diagnosis, prognostic and/or prediction of diabetic chronic wounds.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Case group-CWD | – | Other: collect whole blood, urine and stool samplesdiabetic patients with chronic wounds (CWD) |
| Control group 1-ND | – | Other: collect whole blood, urine and stool samplespatients without diabetes (ND) |
| Control group 2-NWD | – | Other: collect whole blood, urine and stool samplesdiabetic patients without newly identified wound (NWD) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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;
- Special exclusion criteria for blood, urine and stool samples taking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collect whole blood, urine and stool samplescollect whole blood, urine and stool samples | Other | Case group-CWD, Control group 1-ND, Control group 2-NWD |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wang Yibing, Doctor principal investigator
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Biomarker, run by Yibing Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Yibing, Doctor (+86-0531-89268253, wyb0616@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioindicators with differences among groups (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.