NCT03248466

PRG Combined With Autologous BMMSCs for Treatment of Diabetic Foot Ulcer

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Third Military Medical University · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
BIOLOGICAL	PRG combined with BMMSCs transplantation	PRG combined with BMMSCs transplantation

Timeline

• Start date: 2017-08-30
• Primary completion: 2020-01-01
• Completion: 2020-07-01
• First posted: 2017-08-14
• Last updated: 2017-08-14

Locations

2 sites across 1 country: China