Umbilical Cord Blood Mononuclear Cell Gel in the Treatment of Refractory Diabetic Foot Ulcer
NCT ID: NCT04689425
Last Updated: 2022-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
40 participants
INTERVENTIONAL
2021-03-30
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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MNC+PRP
The combination of PRP and MNC
Umbilical cord blood mononuclear cell gel（MNC）
Local wound treatment by combination of PRP and MNC, once;
The platelet rich plasma（PRP）
Local wound treatment by PRP alone, once.
PRP
PRP alone.
The platelet rich plasma（PRP）
Local wound treatment by PRP alone, once.
Interventions
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Umbilical cord blood mononuclear cell gel（MNC）
Local wound treatment by combination of PRP and MNC, once;
The platelet rich plasma（PRP）
Local wound treatment by PRP alone, once.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diabetic foot is diagnosed and Wagner grade is above Ⅱ;
3. The duration of ulcer is 2 months or more, with no healing trend for 2 weeks or more.
4. Fasting blood glucose ≤ 9mmol / L, 2 hours postprandial blood glucose ≤ 13mmol / L;
5. The skin oxygen partial pressure around the wound is more than 20mmHg;
6. Sign written informed consent.
Exclusion Criteria
2. Acute myocardial infarction, heart failure, hepatitis;
3. Active bleeding or hematoma in the wound;
4. Serum albumin \<25g/L;
5. Hemoglobin \<80g/L;
6. Platelets \<50×109/L;
7. Poor cooperate or compliance;The patient cannot cooperate or is.
8. Mentally disabled.
18 Years
80 Years
ALL
No
Sponsors
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Peking University Third Hospital
OTHER
Responsible Party
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Long Zhang
Chief Surgeon
Principal Investigators
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Long Zhang, Dr.
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital Wound Healing Center
Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Long2020-DFU-MNC
Identifier Type: -
Identifier Source: org_study_id
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