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PRG Combined With Autologous BMMSCs for Treatment of Diabetic Foot Ulcer

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ClinicalTrials.gov Identifier: NCT03248466
Recruitment Status : Unknown
Verified August 2017 by Wu Qinan, Third Military Medical University.
Recruitment status was:  Recruiting
First Posted : August 14, 2017
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Wu Qinan, Third Military Medical University

Tracking Information
First Submitted Date  ICMJE August 9, 2017
First Posted Date  ICMJE August 14, 2017
Last Update Posted Date August 14, 2017
Estimated Study Start Date  ICMJE August 30, 2017
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2017)
  • Amputation rate [ Time Frame: up to 6 months ]
    Amputation rate up to 6 months
  • hospital stay [ Time Frame: up to 6 months ]
    hospital stay
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2017)
  • Wound healing time [ Time Frame: up to 6 months ]
    Wound healing time
  • Transcutaneous oxygen partial pressure [ Time Frame: Transcutaneous oxygen partial pressure up to 6 months ]
    Transcutaneous oxygen partial pressure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PRG Combined With Autologous BMMSCs for Treatment of Diabetic Foot Ulcer
Official Title  ICMJE Transplantation of Autologous Platelet Rich Gel Combined With Autologous Bone Marrow Mesenchymal Stem Cells for Treatment of Diabetic Foot Ulcer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE 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
Condition  ICMJE Diabetic Foot Ulcer
Intervention  ICMJE Biological: PRG combined with BMMSCs transplantation
PRG combined with BMMSCs transplantation
Other Name: PRG
Study Arms  ICMJE
  • Placebo Comparator: Traditional treatment
    Traditional treatment such as insulin,antidiabetes,dressing
    Intervention: Biological: PRG combined with BMMSCs transplantation
  • Experimental: PRG combined with BMMSCs transplantation
    Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG combined with BMMSCs
    Intervention: Biological: PRG combined with BMMSCs transplantation
  • No Intervention: PRG treatment
    Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 11, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2020
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03248466
Other Study ID Numbers  ICMJE endocrine department of TMMU
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wu Qinan, Third Military Medical University
Study Sponsor  ICMJE Third Military Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Third Military Medical University
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP