Status:
UNKNOWN
Umbilical Cord Blood Mononuclear Cell Gel in the Treatment of Refractory Diabetic Foot Ulcer
Lead Sponsor:
Peking University Third Hospital
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Umbilical cord blood mononuclear cells (MNC) may improve the wound repair ability. This study aims to investigate the role of MNC in refractory diabetic foot ulcer by comparing the combination of PRP ...
Detailed Description
The difficulty in the healing of diabetic foot is related to the loss of local repair microenvironment. The platelet rich plasma (PRP) can improve the repair ability, however, the requirement for woun...
Eligibility Criteria
Inclusion
- The age of the patients is 18-80 years old;
- Diabetic foot is diagnosed and Wagner grade is above Ⅱ;
- The duration of ulcer is 2 months or more, with no healing trend for 2 weeks or more.
- Fasting blood glucose ≤ 9mmol / L, 2 hours postprandial blood glucose ≤ 13mmol / L;
- The skin oxygen partial pressure around the wound is more than 20mmHg;
- Sign written informed consent.
Exclusion
- Acute spreading infection of the wound, e.g. massive exudation, redness, swelling, heat, pain.
- Acute myocardial infarction, heart failure, hepatitis;
- Active bleeding or hematoma in the wound;
- Serum albumin \<25g/L;
- Hemoglobin \<80g/L;
- Platelets \<50×109/L;
- Poor cooperate or compliance;The patient cannot cooperate or is.
- Mentally disabled.
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04689425
Start Date
March 30 2021
End Date
December 31 2024
Last Update
September 29 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191