The Efficacy and Safety of Umbilical Cord Blood Mononuclear Cell Gel in the Treatment of Refractory Diabetic Foot Ulcer.
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Wound area reduction rate
Study Overview
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 and MNC with PRP alone.
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 wound bed preparation is strict, or treatment failure may occur. Umbilical cord blood mononuclear cells (MNC) may provide a better repair environment through paracrine action. This study aims to investigate the role of MNC in refractory diabetic foot ulcer by comparing the combination of PRP and MNC with PRP alone.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
MNC+PRP
The combination of PRP and MNC
Intervention: Umbilical cord blood mononuclear cell gel（MNC） (Drug)
MNC+PRP
The combination of PRP and MNC
Intervention: The platelet rich plasma（PRP） (Drug)
PRP
PRP alone.
Intervention: The platelet rich plasma（PRP） (Drug)
Outcomes
Primary Outcomes
Wound area reduction rate
Time Frame: one week
The ratio of the reduced area after one week of treatment to the original area
Secondary Outcomes
- Wound healing rate at 4 weeks(4 weeks)
- Amputation rate at 8 weeks(8 weeks)
Investigators
Long Zhang
Chief Surgeon
Peking University Third Hospital