PRG Combined With Autologous BMMSCs for Treatment of Diabetic Foot Ulcer

Third Military Medical University

Status and phase: Unknown; Early Phase 1

Conditions: Diabetic Foot Ulcer

Treatments: Biological: PRG combined with BMMSCs transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03248466

endocrine department of TMMU

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups, including a placebo group

Traditional treatment

Placebo Comparator group

Description:

Traditional treatment such as insulin,antidiabetes,dressing

Treatment:

Biological: PRG combined with BMMSCs transplantation

PRG combined with BMMSCs transplantation

Experimental group

Description:

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

Treatment:

Biological: PRG combined with BMMSCs transplantation

PRG treatment

No Intervention group

Description:

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