PRG Combined With Autologous BMMSCs for Treatment of Diabetic Foot Ulcer

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03248466
• Other study ID #: endocrine department of TMMU
• Status: Recruiting
• Phase: Early Phase 1
• First received: August 9, 2017
• Last updated: August 11, 2017
• Start date: August 30, 2017
• Est. completion date: July 1, 2020

Study information

• Verified date: August 2017
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Biological:
• PRG combined with BMMSCs transplantation
PRG combined with BMMSCs transplantation

Locations

Country	Name	City	State
China	Endocrine Department, the First Affiliated Hospital of the Third Military Medical University	Chongqing	Chongqing
China	Southwest Hospital of the Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amputation rate	Amputation rate up to 6 months	up to 6 months
Primary	hospital stay	hospital stay	up to 6 months
Secondary	Wound healing time	Wound healing time	up to 6 months
Secondary	Transcutaneous oxygen partial pressure	Transcutaneous oxygen partial pressure	Transcutaneous oxygen partial pressure up to 6 months