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Clinical Study of Adipose-derived Stem Cells in the Treatment of Diabetic Foot

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ClinicalTrials.gov Identifier: NCT03916211
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Maoquan Li, Shanghai 10th People's Hospital

Brief Summary:
  1. Program Name: Clinical Study on Treatment of Diabetic Foot with Autologous Adipose Stem Cells
  2. Bidding Unit: Tenth People's Hospital Affiliated to Tongji University
  3. Study subjects: diabetic foot patients
  4. OBJECTIVE: To establish an autologous adipose stem cell therapy for diabetic foot and evaluate its clinical safety and efficacy.
  5. Study Design: Randomized Controlled Clinical Study
  6. Target number of cases: 60
  7. Main evaluation indicators: ulcer healing and amputation, calculating ulcer healing rate = total wound healing cases / total ulcer cases in this group; amputation rate = amputation cases / total cases in this group.
  8. Secondary evaluation indicators: ankle-brachial index (ABI), Ruthford classification, painless walking time Wong-Baker Faces pain score, transcutaneous partial pressure of oxygen (TcPO2), laser Doppler flowmetry, multi-slice spiral CT angiography (CTA)

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Foot Ulcer Biological: MSCs treatment Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Adipose-derived Stem Cells in the Treatment of Diabetic Foot
Estimated Study Start Date : April 20, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: routine treatment
Diabetic foot routine treatment without intervention
Experimental: MSCs treatment
On the basis of routine treatment of diabetic foot, adipose stem cells will be added to treat diabetic foot
Biological: MSCs treatment
intramuscular injection of adipose stem cells treat diabetic foot




Primary Outcome Measures :
  1. ulcer healing rate [ Time Frame: up to 4 weeks ]
    Ulcer healing rate = number of cases of complete wound healing / total number of ulcers in this group

  2. amputation rate [ Time Frame: up to 4 weeks ]
    Amputation rate = number of amputations / total number of amputations in this group


Secondary Outcome Measures :
  1. ultrasound [ Time Frame: 2 weeks ]
    Evaluate patients' limbs blood flow by ultrasound,We will record blood flow velocities, for example, 4ml/second.

  2. ABI(ankle brachial index) [ Time Frame: 2weeks ]
    The ratio of ankle artery pressure to brachial artery pressure was obtained by measuring the contractile pressure of the posterior tibial artery, anterior tibial artery and brachial artery of the ankle.ABI≥0.9 means normal,0.8≥ABI≥0.7means mild arterial obstruction,0.6≥ABI≥0.4means moderate arterial obstruction,ABI<0.4means severe arterial obstruction.

  3. TcPO2(Transcutaneous oxygen pressure) [ Time Frame: 2 weeks ]
    Evaluate patients'oxygen level by TcPO2,TcPO2<20mmHg means very severe lesion.

  4. CTA(Computed Tomography angiography) [ Time Frame: up to 4 weeks ]
    Evaluate patients' limbs blood flow by CTA,We will record blood flow velocities, for example, 4ml/second.

  5. Rutherford Classification [ Time Frame: 2 weeks ]
    Evaluate patients' limbs blood flow by Rutherford classification,Grade 0: Normal Grade 1: Walking over 500 meters with lameness Grade 2: Walking 200-500 meters with lameness Grade 3: Walking within 200 meters with lameness Grade 4: Resting pain Grade 5: Small ulcer Grade 6: Large ulcer.

  6. Wong-Baker Faces Pain Rating Scale [ Time Frame: up to 4 weeks ]
    Evaluate patients' degree of pain by Wong-Baker Faces Pain Rating Scale.There are 6 faces in the Wong-Baker Pain Scale. The first face represents a pain score of 0, and indicates "no hurt". The second face represents a pain score of 2, and indicates "hurts a little bit." The third face represents a pain score of 4, and indicates "hurts a little more". The fourth face represents a pain score of 6, and indicates "hurts even more". The fifth face represents a pain score of 8, and indicates "hurts a whole lot"; the sixth face represents a pain score of 10, and indicates "hurts worst.



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The age ranges from 30 to 65 years. There is no limit for male and female inpatients and outpatients who can be followed up.
  • It conforms to the diagnostic criteria of diabetic foot of the sixth edition of Medical College Textbook Internal Medicine of the Ministry of Health.
  • Severe lower limb ischemia (defined as resting ankle-brachial index (ABI) 0.4-0.8, accompanied by resting pain or intermittent claudication);
  • The expected survival time is longer than one year.
  • No human specific viruses (including HIV, HBV, HCV, HTLV, EBV, CMV, etc.) were detected and screened, and no Treponema pallidum infection was found.
  • Voluntary subjects, the subjects understand the content of the experiment, and voluntarily sign the informed consent before the beginning of the experiment.

Exclusion Criteria:

  • Diabetic retinopathy;
  • There are allergies or contraindications to antiplatelet drugs, anticoagulants, thrombolytics, contrast agents, salicylates, etc.
  • Haemorrhagic tendency, coagulation dysfunction, hypercoagulable constitution or refusal of transfusion therapy exist.
  • In the past five years, patients with malignant diseases or markedly elevated levels of tumor markers in the blood were definitely diagnosed (the estimated survival time was less than 12 months).
  • Pre-acute infectious disease symptoms;
  • Patients with severe liver diseases (such as ascites, esophageal varices, liver transplantation, etc.); hemodynamic instability; renal failure undergoing dialysis; immunosuppressive therapy; decompensated heart failure (New York Heart Association Class III or IV) or myocardial infarction or bypass heart transplantation within three months before the start of the study; Hemorrhagic or ischemic stroke within 3 months before onset;
  • Patients who are still participating in other clinical trials;
  • Other researchers consider that patients who are not eligible for enrollment have other concomitant diseases.
  • Subjects who refused to sign the informed consent or participate in the clinical trial.
  • Immunodeficiency patients;

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): NCT03916211


Contacts
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Contact: Li Maoquan, ph.D 02166313506 cjr.limaoquan@vip.163.com
Contact: Xie Xiaoyun, ph.D 02166313506 xiaoyunxietj@163.com

Sponsors and Collaborators
Maoquan Li
Investigators
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Study Director: Li Xue, ph.D Shanghai 10th People'sHospital

Publications:
Lu Debin, Jiang Youzhao, Liang Ziwen, Li Xiaoyan, Zhang Zhonghui, Chen Bing.Autologous transplantation of bone marrow mesenchymal stem cells on diabetic patients with lower limb ischemia.Journal of Medical Colleges of PLA 2008;23:106-115

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Responsible Party: Maoquan Li, Prof. Dr. Li, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT03916211     History of Changes
Other Study ID Numbers: SC-2018-04-02
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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

Keywords provided by Maoquan Li, Shanghai 10th People's Hospital:
stem cells

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Complications
Diabetic Foot
Foot Ulcer
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetic Neuropathies
Foot Diseases