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Umbilical Cord Blood Mononuclear Cell Gel in the Treatment of Refractory Diabetic Foot Ulcer (DFU-MNC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04689425
Recruitment Status : Recruiting
First Posted : December 30, 2020
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Long Zhang, Peking University Third Hospital

Brief Summary:
Umbilical cord blood mononuclear cells (MNC) may improve the wound repair ability. This study aims to investigate the role of MNC in refractory diabetic foot ulcer by comparing the combination of PRP and MNC with PRP alone.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Drug: Umbilical cord blood mononuclear cell gel(MNC) Drug: The platelet rich plasma(PRP) Phase 3

Detailed Description:
The difficulty in the healing of diabetic foot is related to the loss of local repair microenvironment. The platelet rich plasma (PRP) can improve the repair ability, however, the requirement for wound bed preparation is strict, or treatment failure may occur. Umbilical cord blood mononuclear cells (MNC) may provide a better repair environment through paracrine action. This study aims to investigate the role of MNC in refractory diabetic foot ulcer by comparing the combination of PRP and MNC with PRP alone.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Umbilical Cord Blood Mononuclear Cell Gel in the Treatment of Refractory Diabetic Foot Ulcer.
Actual Study Start Date : March 30, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MNC+PRP
The combination of PRP and MNC
Drug: Umbilical cord blood mononuclear cell gel(MNC)
Local wound treatment by combination of PRP and MNC, once;
Other Name: MNC+PRP

Drug: The platelet rich plasma(PRP)
Local wound treatment by PRP alone, once.
Other Name: PRP

Active Comparator: PRP
PRP alone.
Drug: The platelet rich plasma(PRP)
Local wound treatment by PRP alone, once.
Other Name: PRP




Primary Outcome Measures :
  1. Wound area reduction rate [ Time Frame: one week ]
    The ratio of the reduced area after one week of treatment to the original area


Secondary Outcome Measures :
  1. Wound healing rate at 4 weeks [ Time Frame: 4 weeks ]
    Percentage of patients with healed wound at 4 weeks

  2. Amputation rate at 8 weeks [ Time Frame: 8 weeks ]
    Percentage of patients with major amputation at 8 weeks



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:

  1. The age of the patients is 18-80 years old;
  2. Diabetic foot is diagnosed and Wagner grade is above Ⅱ;
  3. The duration of ulcer is 2 months or more, with no healing trend for 2 weeks or more.
  4. Fasting blood glucose ≤ 9mmol / L, 2 hours postprandial blood glucose ≤ 13mmol / L;
  5. The skin oxygen partial pressure around the wound is more than 20mmHg;
  6. Sign written informed consent.

Exclusion Criteria:

  1. Acute spreading infection of the wound, e.g. massive exudation, redness, swelling, heat, pain.
  2. Acute myocardial infarction, heart failure, hepatitis;
  3. Active bleeding or hematoma in the wound;
  4. Serum albumin <25g/L;
  5. Hemoglobin <80g/L;
  6. Platelets <50×109/L;
  7. Poor cooperate or compliance;The patient cannot cooperate or is.
  8. Mentally disabled.

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): NCT04689425


Contacts
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Contact: Long Zhang, Dr. +8613041210677 longzh2000@163.com
Contact: Wen-Hui Wang, Dr. +8618618269437 wwh0608@126.com

Locations
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China, Beijing
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100191
Contact: long zhang, Dr.    13041210677    longzh2000@163.com   
Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Principal Investigator: Long Zhang, Dr. Peking University Third Hospital Wound Healing Center
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Responsible Party: Long Zhang, Chief Surgeon, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT04689425    
Other Study ID Numbers: Long2020-DFU-MNC
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Time Frame: starting 6 months after publication, for 1 year
Access Criteria: The IPD and supporting information will be shared by contact PI (Long Zhang)'s Email, upon the request of the scientific journal editor.

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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 Long Zhang, Peking University Third Hospital:
Diabetic Foot Ulcer
Umbilical cord blood mononuclear cells
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases