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Prospective trial of multi-omics combined analysis of peripheral blood in patients with diabetic foot

Prospective trial of multi-omics 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
ChiCTR2300074991
Enrollment
Unknown
Registered
2023-08-22
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-28

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

Conditions

Diabetic foot

Interventions

Diagnosed diabetes, taking medicine regularly and having no symptoms related to diabetic foot.:NA
Wagner scale 0~1 diabetic foot patients.:NA
Patients with diabetic foot with Wagner scale 2~5.:NA

Sponsors

Nanjing nanyao medicine technology co., ltd
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 following requirements: =1 mL of human serum samples; 2) Meet the storage requirements, that is, the samples must be stored at room temperature after collection and centrifuged within 12 hours after collection. And then stored in the dark at-60 DEG C until analysis; 3) The patient's age is =18 years old, regardless of sex; 4) The body mass index (BMI) at screening is between 18.5 and 30 kg/m2 (inclusive); 5) Patients with clinically diagnosed diabetes meet one of the following three conditions: A) Diagnosing diabetes, taking medicine regularly and having no symptoms related to diabetic foot; B) diabetic foot patients with b) Wagner classification method (0~1); C) patients with diabetic foot with c) Wagner classification method.

Exclusion criteria

Exclusion criteria: 1) The sample shows coagulation or hemolysis; 2) Incorrect collection or storage of samples; 3) screening for hyperthyroidism or hypothyroidism that has not been well treated; 4) Patients with systolic blood pressure =180 mmHg and/or diastolic blood pressure =110 mmHg during screening; 5) Suffering from hypokalemia, hypocalcemia or hypocalcemia at the time of screening; 6) When screening, any laboratory inspection index meets the following standards: A) alanine aminotransferase > 2.0× ULN and/or aspartate aminotransferase > 2.0× ULN and/or total bilirubin > >1.5×ULN;; B) serum creatinine > 1.5 × uln (except for diabetic foot patients with Wagner classification 2~5); C) glomerular filtration rate (EGFR) 5.7mmol/L and cholesterol > 1.5×ULN;; F) Patients with abnormal hemoglobin and clinical significance as judged by the researcher (except diabetic foot patients with Wagner classification 2~5); G) TSH > 10 MIU/L, and it has clinical significance as judged by researchers; 7) HBsAg positive, HCV antibody positive, HIV antibody positive, and/or Treponema pallidum antibody positive; 8) Drug, alcohol dependence or history of abuse (drinking 21 units of alcohol every week: 1 unit = 360 mL of beer, 45 mL of spirits or 150 mL); of wine); 9) Patients with major physical diseases such as neurological diseases, brain trauma, cardiovascular and cerebrovascular diseases, and severe liver and kidney dysfunction; 10) pregnant or lactating women; 11) Patients with surgery or other major medical history within 6 months; 12) being treated with hormone drugs; 13) Patients who the researcher thinks are not suitable to participate in this trial due to other factors.

Design outcomes

Primary

MeasureTime frame
Serum metabolites;

Countries

China

Contacts

Public ContactYanmeiLiu

Director of endocrinology department

lym_jsyc@sina.com+86 158 6207 5033

Outcome results

None listed

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