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Study on the therapeutic effect of pentoxifylline on high risk foot of Diabetes

Study on the therapeutic effect of pentoxifylline on high risk foot of Diabetes

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400080398
Enrollment
Unknown
Registered
2024-01-29
Start date
2024-03-19
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

High risk foot of diabetes

Interventions

Group one (Standard treatment and pentoxifylline(0.4g bid*12W)):NA
Group two (Standard treatment without pentoxifylline,but you can add one of betamethasone sodium, cilostazol or aspirin.):NA

Sponsors

Subei Hospital of Jiangsu Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: The patients with diabetes high-risk foot who are 18-60 years old at the intelligent follow-up platform of diabetes high-risk foot in our hospital signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with acute myocardial infarction. 2. Patients with severe coronary atherosclerosis that has not been effectively controlled (such as those with untreated three vessel lesions identified by coronary angiography) and unstable angina. 3. Individuals with active mental illness and severe depression, as determined by researchers based on clinical interviews, are at risk of causing harm to themselves or others. 4. Women with recent pregnancy plans and lactation. 5. There is a significant abnormality in coagulation function leading to a tendency for bleeding, and a history of active gastrointestinal bleeding or cerebral hemorrhage within the past six months. 6. Individuals who are allergic or intolerant to pentoxifylline. 7. Individuals with a history of mental illness leading to cognitive impairment and dementia, such as Parkinson's disease, Lewy body disease, any type of frontotemporal dementia, Huntington's disease, amyotrophic lateral sclerosis, multiple sclerosis, systemic lupus erythematosus, neurosyphilis, HIV, hypoxic brain injury, and major head injuries with loss of consciousness, resulting in sustained cognitive impairment. 8.8. Based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, there is evidence of clinically significant or unstable mental illness, including schizophrenia or other mental illnesses or bipolar disorder. According to the researcher's judgment, patients with a history of severe depression. Based on clinical interviews, researchers have determined that there is a risk of imminent harm to oneself or others. Intentional suicidal thoughts, whether with or without plans or methods, or suicidal behavior within the 6 months prior to the screening date, must be excluded. 9. Patients who have used GLP-1 or DPP-4 hypoglycemic drugs within 3 months.

Design outcomes

Primary

MeasureTime frame
ABI;Peak blood flow of dorsal foot artery;Mental and behavioral symptom assessment form MMSE;Mental and behavioral symptom assessment form MoCA;Hba1c;LDL-C;Skin Niacin Test;MRI brain region information analysis;

Countries

China

Contacts

Public ContactLiu Yan

Subei Hospital of Jiangsu Province

cathy1sun@126.com+86 180 5106 1258

Outcome results

None listed

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