Umbilical Cord Blood Mononuclear Cell Gel in the Treatment of Refractory Diabetic Foot Ulcer

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Efficacy and Safety of Umbilical Cord Blood Mononuclear Cell Gel in the Treatment of Refractory Diabetic Foot Ulcer.

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Drug: Umbilical cord blood mononuclear cell gel（MNC）
* Drug: The platelet rich plasma（PRP）


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MNC+PRP<br>The combination of PRP and MNC | Drug: Umbilical cord blood mononuclear cell gel（MNC）<br>* Local wound treatment by combination of PRP and MNC, once;<br>* Other names: MNC+PRP;Drug: The platelet rich plasma（PRP）<br>* Local wound treatment by PRP alone, once.<br>* Other names: PRP;|
| Active Comparator: PRP<br>PRP alone. | Drug: The platelet rich plasma（PRP）<br>* Local wound treatment by PRP alone, once.<br>* Other names: PRP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound area reduction rate | The ratio of the reduced area after one week of treatment to the original area | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing rate at 4 weeks | Percentage of patients with healed wound at 4 weeks | 4 weeks | 
| Amputation rate at 8 weeks | Percentage of patients with major amputation at 8 weeks | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Foot Ulcer, Umbilical cord blood mononuclear cells