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PRG Combined With Autologous BMMSCs for Treatment of Diabetic Foot Ulcer

Primary Purpose

Diabetic Foot Ulcer

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
PRG combined with BMMSCs transplantation
Sponsored by
Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring platelet rich gel, BMMSCs, diabetic foot ulcer

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Southwest Hospital of the Third Military Medical UniversityRecruiting
  • Endocrine Department, the First Affiliated Hospital of the Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

No Intervention

Arm Label

Traditional treatment

PRG combined with BMMSCs transplantation

PRG treatment

Arm Description

Traditional treatment such as insulin,antidiabetes,dressing

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

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

Outcomes

Primary Outcome Measures

Amputation rate
Amputation rate up to 6 months
hospital stay
hospital stay

Secondary Outcome Measures

Wound healing time
Wound healing time
Transcutaneous oxygen partial pressure
Transcutaneous oxygen partial pressure

Full Information

First Posted
August 9, 2017
Last Updated
August 11, 2017
Sponsor
Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03248466
Brief Title
PRG Combined With Autologous BMMSCs for Treatment of Diabetic Foot Ulcer
Official Title
Transplantation of Autologous Platelet Rich Gel Combined With Autologous Bone Marrow Mesenchymal Stem Cells for Treatment of Diabetic Foot Ulcer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2017 (Anticipated)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
platelet rich gel, BMMSCs, diabetic foot ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
diabetic foot ulcer which Wagner classification at 2-3 grade.
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional treatment
Arm Type
Placebo Comparator
Arm Description
Traditional treatment such as insulin,antidiabetes,dressing
Arm Title
PRG combined with BMMSCs transplantation
Arm Type
Experimental
Arm Description
Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG combined with BMMSCs
Arm Title
PRG treatment
Arm Type
No Intervention
Arm Description
Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG
Intervention Type
Biological
Intervention Name(s)
PRG combined with BMMSCs transplantation
Other Intervention Name(s)
PRG
Intervention Description
PRG combined with BMMSCs transplantation
Primary Outcome Measure Information:
Title
Amputation rate
Description
Amputation rate up to 6 months
Time Frame
up to 6 months
Title
hospital stay
Description
hospital stay
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Wound healing time
Description
Wound healing time
Time Frame
up to 6 months
Title
Transcutaneous oxygen partial pressure
Description
Transcutaneous oxygen partial pressure
Time Frame
Transcutaneous oxygen partial pressure up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Southwest Hospital of the Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
+86
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wu qinan, doctor
Phone
13452867542
Email
wqn11@126.com
Facility Name
Endocrine Department, the First Affiliated Hospital of the Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
qinan wu, master
Phone
02368765217
Ext
86
Email
wqn11@126.com
First Name & Middle Initial & Last Name & Degree
qinan wu, master

12. IPD Sharing Statement

Plan to Share IPD
No

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PRG Combined With Autologous BMMSCs for Treatment of Diabetic Foot Ulcer

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