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A prospective trial of multiomics combined analysis of peripheral blood in patients with diabetic foot

A prospective trial of multiomics combined analysis of peripheral blood in patients with diabetic foot

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400084822
Enrollment
Unknown
Registered
2024-05-24
Start date
2024-05-30
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic foot

Interventions

A (Confirmed diabetes, regular medication and no diabetic foot-related symptoms):None
B (diabetic foot patients with Wagner grade 0 to 1):None
C (Patients with diabetic foot by Wagner classification, grade 2 to 5):None

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) The sample comes from the remaining samples of clinical testing, and the remaining sample size meets: the human serum sample of 1 mL; (2) Meet the storage requirements, that is, the samples must be stored at room temperature after the collection, and centrifuged within 12 hours after the collection. And then stored at-60? until analysis; (3) The patient is 18 years old, and the gender is not limited; (4) Body mass index (BMI) at screening was between 18.5-30 kg/m^2 (inclusive); (5) Patients with clinically diagnosed diabetes who meet one of the following 3 conditions: (A) Diagnosed with diabetes, taking regular medication and having no diabetic foot-related symptoms; (B) Wagner foot patients with grade 0 to 1; (C) Patients with diabetic foot by Wagner grade 2 to 5.

Exclusion criteria

Exclusion criteria: (1) The sample showed blood coagulation or hemolysis phenomenon; (2) Incorrect collection or storage of samples; (3) Hyperthyroidism or hypothyroidism that was not well treated during screening; (4) Patients with a systolic blood pressure of 180 mmHg and / or a diastolic blood pressure of 110 mmHg at screening; (5) Hypokalemia, hypocalcemia or hypomagnesemia during screening; (6) Any of the laboratory indicators met the following criteria: (A) glutamate aminotransferase> 2.0 ULN and / or glutamate aminotransferase> 2.0 ULN and / or total bilirubin> 1.5 ULN; (B) blood creatinine> 1.5 ULN (except for diabetic foot patients with Wagner grade 2~5); (C) Glomerular filtration rate (eGFR) 5.7 mmol/L, and cholesterol> 1.5 ULN; (F) abnormal hemoglobin and clinically significant by the investigator (except diabetic foot patients with Wagner grade 2 to 5); (G) Blood thyroid-stimulating hormone (TSH)> 10 mIU / L, and is clinically significant as judged by the investigator; (7) positive hepatitis B surface antigen, positive hepatitis C antibody, positive HIV antibody, and / or positive Treponema pallidum antibody; (8) Drug, alcohol dependence or a history of abuse (drinking 21 units of alcohol per week: 1 unit = 360 mL of beer, or 45 mL of spirits, or 150 mL of wine); (9) Patients with neurological diseases, brain trauma, cardiovascular and cerebrovascular diseases, and severe liver and kidney function abnormalities; (10) women during pregnancy or lactation; (11) Patients with surgery or other major medical history within 6 months; (12) Being on hormonal drug therapy;

Design outcomes

Primary

MeasureTime frame
Serum metabolite concentrations;

Countries

China

Contacts

Public ContactLi Ke

The First Affiliated Hospital of Soochow University

Likefggf@163.com+86 153 0621 6051

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026