Clinical trial NCT05342740: Study of Biomarkers in Diabetic Chronic Wounds
Official title: A Multicenter Case Control Study of Biomarkers in Diabetic Chronic Wounds Based on Combined Multi-omics Analysis Techniques
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Biomarker
Chronic Wound
Keywords: chronic diabetic wound
early diagnosis
prognostic
prediction
biomarker
muti-omics
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 930
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 75;
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:

1. With sever acute underlying diseases of the brain, heart, lungs, liver and/or kidney;
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;
3. Special exclusion criteria for blood, urine and stool samples taking.

Primary outcomes:
measure: Bioindicators with differences among groups
timeFrame: Through study completion, an average of 1 year
measure: Basic clinical and demographic information of participants in groups
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
name: Wang Yibing, Doctor
role: PRINCIPAL_INVESTIGATOR
References: