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A Clinical Study Using Adipose-derived Stem Cells for Diabetic Foot

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ClinicalTrials.gov Identifier: NCT02831075
Recruitment Status : Unknown
Verified April 2017 by Jie Shen, The Third Affiliated Hospital of Southern Medical University.
Recruitment status was:  Recruiting
First Posted : July 13, 2016
Last Update Posted : April 7, 2017
Sponsor:
Collaborators:
Nanfang Hospital of Southern Medical University
Academy Military Medical Science, China
The Fifth Affiliated Hospital of Southern Medical University
Southern Medical University, China
Information provided by (Responsible Party):
Jie Shen, The Third Affiliated Hospital of Southern Medical University

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.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Disease Ischemia Diabetic Foot Biological: Adipose-derived stem cell Biological: saline Phase 1

Detailed Description:

Diabetic foot is one of the most serious chronic complications of diabetic patients, and still lacking effective treatments.

Stem cell therapy has been a new and effective therapy in recent years for diabetic foot. Combined with the previous studies of our research group, this study intends to transform part of the results of this research, establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study Using Adipose-derived Stem Cells for Diabetic Foot
Study Start Date : January 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adipose-derived stem cell
Mesenchymal stem cells derived from adipocyte transplantation
Biological: Adipose-derived stem cell
stem cell acquisition, processing and reinfection, to evaluate the efficacy of adipose-derived stem cell.

Placebo Comparator: saline
saline injections
Biological: saline



Primary Outcome Measures :
  1. Area of diabetic foot ulcers [ Time Frame: 3 months ]
    To determine the ability of MSC to facilitate and accelerate diabetic foot ulcers healing.


Secondary Outcome Measures :
  1. Improvement of transcutaneous oxygen partial pressure (TcPO2) [ Time Frame: 3 months ]
    Improvement of local perfusion.

  2. Improvement of microvascular cutaneous reactivity by laser Doppler perfusion monitoring (LDPM) [ Time Frame: 3 months ]
  3. Pain (Visual-Analog Scale) [ Time Frame: 3 months ]
    Measure of the subjective symptom of pain.

  4. Walking distance (treadmill) if possible [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT02831075


Contacts
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Contact: Jie Shen +86 13808893818 shenjiedr@163.com

Locations
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China, Guangdong
the Third Affiliated Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Zhang Qun    020-62784060    Zq1979@smu.edu.cn   
Principal Investigator: Jie Shen         
Sponsors and Collaborators
Jie Shen
Nanfang Hospital of Southern Medical University
Academy Military Medical Science, China
The Fifth Affiliated Hospital of Southern Medical University
Southern Medical University, China
Investigators
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Principal Investigator: Jie Shen The Third Affiliated Hospital of Southern Medical University

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Responsible Party: Jie Shen, professor, The Third Affiliated Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02831075     History of Changes
Other Study ID Numbers: Southern Medical University
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jie Shen, The Third Affiliated Hospital of Southern Medical University:
Adipose-derived Stem Cells
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Skin Diseases
Endocrine System Diseases
Arterial Occlusive Diseases
Diabetic Foot
Ischemia
Diabetic Angiopathies
Foot Ulcer
Leg Ulcer
Skin Ulcer
Diabetes Complications
Diabetes Mellitus
Diabetic Neuropathies
Atherosclerosis
Arteriosclerosis