ClinicalTrials.gov
ClinicalTrials.gov Menu

PRG Combined With Autologous BMMSCs for Treatment of Diabetic Foot Ulcer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03248466
Recruitment Status : Recruiting
First Posted : August 14, 2017
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Wu Qinan, Third Military Medical University

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Biological: PRG combined with BMMSCs transplantation Early Phase 1

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: diabetic foot ulcer which Wagner classification at 2-3 grade.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transplantation of Autologous Platelet Rich Gel Combined With Autologous Bone Marrow Mesenchymal Stem Cells for Treatment of Diabetic Foot Ulcer
Estimated Study Start Date : August 30, 2017
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: PRG
No Intervention: PRG treatment
Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG



Primary Outcome Measures :
  1. Amputation rate [ Time Frame: up to 6 months ]
    Amputation rate up to 6 months

  2. hospital stay [ Time Frame: up to 6 months ]
    hospital stay


Secondary Outcome Measures :
  1. Wound healing time [ Time Frame: up to 6 months ]
    Wound healing time

  2. Transcutaneous oxygen partial pressure [ Time Frame: Transcutaneous oxygen partial pressure up to 6 months ]
    Transcutaneous oxygen partial pressure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248466


Locations
China, Chongqing
Southwest Hospital of the Third Military Medical University Recruiting
Chongqing, Chongqing, China, +86
Contact: wu qinan, doctor    13452867542    wqn11@126.com   
Endocrine Department, the First Affiliated Hospital of the Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400038
Contact: qinan wu, master    02368765217 ext 86    wqn11@126.com   
Sub-Investigator: qinan wu, master         
Sponsors and Collaborators
Third Military Medical University

Responsible Party: Wu Qinan, Doctor, Third Military Medical University
ClinicalTrials.gov Identifier: NCT03248466     History of Changes
Other Study ID Numbers: endocrine department of TMMU
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wu Qinan, Third Military Medical University:
platelet rich gel
BMMSCs
diabetic foot ulcer

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases