PRG Combined With Autologous BMMSCs for Treatment of Diabetic Foot Ulcer

August 11, 2017 updated by: Wu Qinan, Third Military Medical University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Recruiting
        • Endocrine Department, the First Affiliated Hospital of the Third Military Medical University
        • Contact:
          • qinan wu, master
          • Phone Number: 86 02368765217
          • Email: wqn11@126.com
        • Sub-Investigator:
          • qinan wu, master
      • Chongqing, Chongqing, China, +86
        • Recruiting
        • Southwest Hospital of the Third Military Medical University
        • Contact:
          • wu qinan, doctor
          • Phone Number: 13452867542
          • Email: wqn11@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Traditional treatment
Traditional treatment such as insulin,antidiabetes,dressing
Biological: PRG combined with BMMSCs transplantation
PRG combined with BMMSCs transplantation
Other Names:
  • PRG
Experimental: PRG combined with BMMSCs transplantation
Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG combined with BMMSCs
Biological: PRG combined with BMMSCs transplantation
PRG combined with BMMSCs transplantation
Other Names:
  • PRG
No Intervention: PRG treatment
Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amputation rate
Time Frame: up to 6 months
Amputation rate up to 6 months
up to 6 months
hospital stay
Time Frame: up to 6 months
hospital stay
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound healing time
Time Frame: up to 6 months
Wound healing time
up to 6 months
Transcutaneous oxygen partial pressure
Time Frame: Transcutaneous oxygen partial pressure up to 6 months
Transcutaneous oxygen partial pressure
Transcutaneous oxygen partial pressure up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 30, 2017

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

August 9, 2017

First Submitted That Met QC Criteria

August 11, 2017

First Posted (Actual)

August 14, 2017

Study Record Updates

Last Update Posted (Actual)

August 14, 2017

Last Update Submitted That Met QC Criteria

August 11, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • endocrine department of TMMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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