Status:
UNKNOWN
Human Cord Blood Mononuclear Cells in the Treatment of Refractory Diabetic Foot
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsors:
Shandong Qilu Stem Cells Engineering Co., Ltd.
Conditions:
Refractory Diabetic Foot
Human Cord Blood-derived Mononuclear Cells
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Refractory diabetic foot is one of the most serious and costly chronic complications of diabetes. It is the leading cause of nontraumatic lower-extremity amputations while the conventional treatment i...
Detailed Description
Refractory diabetic foot is one of the most serious and costly chronic complications of diabetes, and is the leading cause of nontraumatic lower-extremity amputations. Conventional treatment is sympto...
Eligibility Criteria
Inclusion
- Patients aged 18-80 years;
- Meet the diagnostic criteria of diabetic foot by International Clinical Guidelines for Diabetic Foot;
- Ulcer course ≥8 weeks, Wagner grade ≥2;
- There was no healing trend (no reduction in wound size and no obvious new granulation tissue) after 4 weeks or above treatment. Or the ulcer was further aggravated (by Wagner's grade assessment) in the course of standardized treatment;
- Fasting blood glucose ≤9mmol/L, 2h postprandial blood glucose ≤13mmol/L;
- Signing informed consent.
Exclusion
- Patients with a history of ketoacidosis and hyperosmosis within 6 months;
- Patients with viral infection (treponema pallidum, active hepatitis, HIV, Epstein-Barr virus, etc.)
- Patients with malignant disease or cured of basal cell carcinoma within the past 5 years;
- Creatinine clearance \< 45ml/min;
- Patients with severe heart failure (NYHA III-IV);
- Patients with a history of myocardial infarction or cerebral infarction in the last 3 months;
- Patients who have received cell or growth factor therapy in the past year;
- Patients during pregnancy or lactation;
- Patients with abnormal thyroid dysfunction history or abnormal control through drug treatment;
- Patients with severe hepatic failure (ALT, AST: above 3 times the upper limit of normal);
- Lower extremity arterial with large artery occlusion by ultrasound image;
- Patients with a history of severe coagulation disorder or hemorrhagic disease;
- Patients with sequelae of cerebral infarction or other reasons that cannot extend their lower limbs flat;
- Patients with psychological or mental disorders who cannot cooperate with treatment;
- Participate in other clinical research within the past three months;
- Patients are unable to complete the study or comply with the requirements of the study by investigator's judgment.
Key Trial Info
Start Date :
May 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 28 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05999656
Start Date
May 28 2023
End Date
November 28 2024
Last Update
August 21 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
the First Affiliated Hospital of Nanjing Medical University
Nanjing, China