PRG Combined With Autologous BMMSCs for Treatment of Diabetic Foot Ulcer

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-30

Study Completion Date

2020-07-01

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.

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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.

Conditions

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Diabetic Foot Ulcer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

diabetic foot ulcer which Wagner classification at 2-3 grade.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Traditional treatment

Traditional treatment such as insulin,antidiabetes,dressing

Group Type PLACEBO_COMPARATOR

PRG combined with BMMSCs transplantation

Intervention Type BIOLOGICAL

PRG combined with BMMSCs transplantation

Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG combined with BMMSCs

Group Type EXPERIMENTAL

PRG combined with BMMSCs transplantation

Intervention Type BIOLOGICAL

PRG combined with BMMSCs transplantation

PRG treatment

Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PRG combined with BMMSCs transplantation

Intervention Type BIOLOGICAL

Other Intervention Names

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PRG

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No