NCT03248466

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Aug 2017

Typical duration for early_phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

August 30, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

Enrollment Period

2.3 years

First QC Date

August 9, 2017

Last Update Submit

August 11, 2017

Conditions

Diabetic Foot Ulcer

Keywords

platelet rich gelBMMSCsdiabetic foot ulcer

Outcome Measures

Primary Outcomes (2)

  • Amputation rate

    Amputation rate up to 6 months

    up to 6 months

  • hospital stay

    hospital stay

    up to 6 months

Secondary Outcomes (2)

  • Wound healing time

    up to 6 months

  • Transcutaneous oxygen partial pressure

    Transcutaneous oxygen partial pressure up to 6 months

Study Arms (3)

Traditional treatment

PLACEBO COMPARATOR

Traditional treatment such as insulin,antidiabetes,dressing

Biological: PRG combined with BMMSCs transplantation

PRG combined with BMMSCs transplantation

EXPERIMENTAL

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

Biological: PRG combined with BMMSCs transplantation

PRG treatment

NO INTERVENTION

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

Interventions

PRG combined with BMMSCs transplantationBIOLOGICAL

PRG combined with BMMSCs transplantation

Also known as: PRG
PRG combined with BMMSCs transplantationTraditional treatment

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic foot according to The Wagner is 2-3 graded;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Southwest Hospital of the Third Military Medical University

Chongqing, Chongqing Municipality, +86, China

RECRUITING

Endocrine Department, the First Affiliated Hospital of the Third Military Medical University

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: diabetic foot ulcer which Wagner classification at 2-3 grade.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 9, 2017

First Posted

August 14, 2017

Study Start

August 30, 2017

Primary Completion

January 1, 2020

Study Completion

July 1, 2020

Last Updated

August 14, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)