NCT02796079

Brief Summary

Stem cell therapy has been a new and effective therapy in recent years for diabetic foot.This study intends to establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

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
240

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 6, 2017

Status Verified

April 1, 2017

Enrollment Period

2.9 years

First QC Date

May 30, 2016

Last Update Submit

April 4, 2017

Conditions

Peripheral Vascular DiseaseIschemiaDiabetic Foot

Outcome Measures

Primary Outcomes (1)

  • Area of diabetic foot ulcers

    To determine the ability of MSC to facilitate and accelerate diabetic foot ulcers healing.

    3 months

Secondary Outcomes (4)

  • Improvement of transcutaneous oxygen partial pressure (TcPO2)

    3 months

  • Improvement of microvascular cutaneous reactivity by laser Doppler perfusion monitoring (LDPM)

    3 months

  • Pain (Visual-Analog Scale)

    3 months

  • Walking distance (treadmill) if possible

    3 months

Study Arms (2)

Autologous Bone Marrow Stem Cell

EXPERIMENTAL

Mesenchymal stem cells derived from bone marrow infusion

Biological: mesenchymal stem cells

saline

PLACEBO COMPARATOR

saline injections

Biological: saline

Interventions

mesenchymal stem cellsBIOLOGICAL

stem cell acquisition, processing and reinfection, to evaluate the efficacy by using autologous bone marrow stem cell

Autologous Bone Marrow Stem Cell
salineBIOLOGICAL

saline injections

saline

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes mellitus Type 2 or Type 1
  • Age between 18-80 years
  • Chronic foot ulcer more than 6 weeks
  • No sufficient response to best standard care delivered for six weeks.
  • PAD up to Fontaine stage III or IV period
  • CLI with the ankle brachial index (index ankle-brachial, ABI) \<0.7 and (or) the percutaneous oxygen partial pressure (oxygen tension transcutaneous, TcPO2) \<30mmHg

You may not qualify if:

  • HbA1c \>12%
  • Hemoglobin \<10 mg/dl
  • Creatinine clearance rate \<30ml/min
  • Systemic bacterial, viral infections (Mei Du, hepatitis, cytomegalovirus infection, HIV, B19 infection, herpes virus infection) and sepsis
  • Have accepted the treatment of stem cells or growth factors
  • Have a history of malignant disease
  • Pregnancy
  • Mental illness history
  • Abnormal coagulation function
  • Allergic reaction
  • Severe cardiac insufficiency (III-IV NYHA)
  • Using vasoactive substances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Peripheral Vascular DiseasesIschemiaDiabetic Foot

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDiabetic AngiopathiesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jie Shen

    The Third Affiliated Hospital of Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Shen

CONTACT

+86 13808893818shenjiedr@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

May 30, 2016

First Posted

June 10, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

April 6, 2017

Record last verified: 2017-04

Locations

CN(1)