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

September 28, 2022 updated by: Long Zhang, Peking University Third Hospital

The Efficacy and Safety of Umbilical Cord Blood Mononuclear Cell Gel in the Treatment of Refractory Diabetic Foot Ulcer.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Wen-Hui Wang, Dr.
  • Phone Number: +8618618269437
  • Email: wwh0608@126.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • MNC+PRP
Drug: The platelet rich plasma（PRP）
Local wound treatment by PRP alone, once.
Other Names:
  • PRP
Active Comparator: PRP
PRP alone.
Drug: The platelet rich plasma（PRP）
Local wound treatment by PRP alone, once.
Other Names:
  • PRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound area reduction rate
Time Frame: one week
The ratio of the reduced area after one week of treatment to the original area
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound healing rate at 4 weeks
Time Frame: 4 weeks
Percentage of patients with healed wound at 4 weeks
4 weeks
Amputation rate at 8 weeks
Time Frame: 8 weeks
Percentage of patients with major amputation at 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Long Zhang, Dr., Peking University Third Hospital Wound Healing Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

December 24, 2020

First Submitted That Met QC Criteria

December 24, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Long2020-DFU-MNC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

starting 6 months after publication, for 1 year

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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