PRG Combined With Autologous BMMSCs for Treatment of Diabetic Foot Ulcer

Study Overview
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Brief Summary
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To investigate the treatment effect between Traditional treatment and transplantation of autologous PRG combined with autologous BMMSCs for treatment of diabetic foot ulcer.

Detailed Description
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60 diabetic foot ulcer in our hospital will divide into 3 groups: group A (20 diabetic foot ulcer who give Traditional treatment), group B (20 diabetic foot ulcer who give Traditional treatment and transplantation of autologous platelet rich gel)，group C (20 diabetic foot ulcer who give Traditional treatment and transplantation of autologous platelet rich gel combined with autologous bone marrow mesenchymal stem cells). The age, height, weight, blood glucose, glycosylated hemoglobin A1c（HbA1c）, lipid, blood pressure, course of disease, Wound healing rate,transcutaneous oxygen pressure,Amputation rate,Hospital stay will record respectively. And High-sensitive C-reactive protein (HsCRP) and Tumor necrosis factor-α（TNF-α） will detect as Baseline. After each group's treatment, Change from baseline of all indexes will record, one way Analysis of Variance will be analyzed the significantion among 3 groups.

Official Title
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Transplantation of Autologous Platelet Rich Gel Combined With Autologous Bone Marrow Mesenchymal Stem Cells for Treatment of Diabetic Foot Ulcer

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Biological: PRG combined with BMMSCs transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetic foot according to The Wagner is 2-3 graded; Exclusion Criteria: Type 1 diabetes mellitus,presence of autoimmune diabetes; Gestational diabetes; Patients with heart, liver, or renal function impairment;presence of severe infections or cerebrovascular disease.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: diabetic foot ulcer which Wagner classification at 2-3 grade.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Traditional treatment<br>Traditional treatment such as insulin,antidiabetes,dressing | Biological: PRG combined with BMMSCs transplantation<br>* PRG combined with BMMSCs transplantation<br>* Other names: PRG;|
| Experimental: PRG combined with BMMSCs transplantation<br>Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG combined with BMMSCs | Biological: PRG combined with BMMSCs transplantation<br>* PRG combined with BMMSCs transplantation<br>* Other names: PRG;|
| No Intervention: PRG treatment<br>Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amputation rate | Amputation rate up to 6 months | up to 6 months | 
| hospital stay | hospital stay | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing time | Wound healing time | up to 6 months | 
| Transcutaneous oxygen partial pressure | Transcutaneous oxygen partial pressure | Transcutaneous oxygen partial pressure up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet rich gel, BMMSCs, diabetic foot ulcer