Stem Cell Derived Exome for Treatment of Diabetic Foot

Launched by SECOND AFFILIATED HOSPITAL OF GUANGZHOU MEDICAL UNIVERSITY · Jun 26, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for diabetic foot using something called stem cell-derived exosomes. Exosomes are tiny particles that come from stem cells and may help heal wounds or improve the condition of the foot. The main goal of this study is to check if this treatment is safe and effective for patients suffering from diabetic foot, a serious complication of diabetes that can lead to infections and other problems.

To participate in this trial, individuals need to be diagnosed with diabetic foot and be between the ages of 18 and 90. They must also be able to provide informed consent, meaning they understand the trial and agree to take part. Participants will go through tests to ensure they are healthy enough for the study. This trial is not yet recruiting participants, but once it begins, those who join can expect regular visits to the clinic for treatment and follow-up assessments to monitor their progress. It's important to know that this trial is in the early phase, focusing on safety, so more research will follow based on the results.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Clinical diagnosis of diabetic foot.
• • 2. Signed informed consent before recruiting.
• • 3. Age above 18 years or less than 90 years.
• • 4. ECOG score \< 4
• • 5. Tolerable coagulation function or reversible coagulation disorders
• • 6. Laboratory examination test within 7 days prior to procedure: WBC≥3.0×10E9/L; Hb≥90g/L； PLT ≥50×10E9/L；INR \< 2.3 or PT \< 6 seconds above control；Cr ≤ 145.5 umul/L；Albumin \> 28 g/L；Total bilirubin \< 51 μmol/L
• • 7. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
• Exclusion Criteria:
• • 1. Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
• • 2. Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;
• • 3. Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
• • 4. Patients have poor compliance.
• • 5. Allergic to the skin drug;
• • 6. Any agents which could affect the absorption or pharmacokinetics of the study drugs
• • 7. Other conditions that investigator decides not suitable for the trial.