search
Back to results

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

Primary Purpose

Diabetic Foot Ulcer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Umbilical cord blood mononuclear cell gel（MNC）
The platelet rich plasma（PRP）
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetic Foot Ulcer, Umbilical cord blood mononuclear cells

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MNC+PRP

PRP

Arm Description

The combination of PRP and MNC

PRP alone.

Outcomes

Primary Outcome Measures

Wound area reduction rate
The ratio of the reduced area after one week of treatment to the original area

Secondary Outcome Measures

Wound healing rate at 4 weeks
Percentage of patients with healed wound at 4 weeks
Amputation rate at 8 weeks
Percentage of patients with major amputation at 8 weeks

Full Information

First Posted
December 24, 2020
Last Updated
September 28, 2022
Sponsor
Peking University Third Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04689425
Brief Title
Umbilical Cord Blood Mononuclear Cell Gel in the Treatment of Refractory Diabetic Foot Ulcer
Acronym
DFU-MNC
Official Title
The Efficacy and Safety of Umbilical Cord Blood Mononuclear Cell Gel in the Treatment of Refractory Diabetic Foot Ulcer.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
Diabetic Foot Ulcer, Umbilical cord blood mononuclear cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MNC+PRP
Arm Type
Experimental
Arm Description
The combination of PRP and MNC
Arm Title
PRP
Arm Type
Active Comparator
Arm Description
PRP alone.
Intervention Type
Drug
Intervention Name(s)
Umbilical cord blood mononuclear cell gel（MNC）
Other Intervention Name(s)
MNC+PRP
Intervention Description
Local wound treatment by combination of PRP and MNC, once;
Intervention Type
Drug
Intervention Name(s)
The platelet rich plasma（PRP）
Other Intervention Name(s)
PRP
Intervention Description
Local wound treatment by PRP alone, once.
Primary Outcome Measure Information:
Title
Wound area reduction rate
Description
The ratio of the reduced area after one week of treatment to the original area
Time Frame
one week
Secondary Outcome Measure Information:
Title
Wound healing rate at 4 weeks
Description
Percentage of patients with healed wound at 4 weeks
Time Frame
4 weeks
Title
Amputation rate at 8 weeks
Description
Percentage of patients with major amputation at 8 weeks
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The age of the patients is 18-80 years old; Diabetic foot is diagnosed and Wagner grade is above Ⅱ; The duration of ulcer is 2 months or more, with no healing trend for 2 weeks or more. Fasting blood glucose ≤ 9mmol / L, 2 hours postprandial blood glucose ≤ 13mmol / L; The skin oxygen partial pressure around the wound is more than 20mmHg; Sign written informed consent. Exclusion Criteria: Acute spreading infection of the wound, e.g. massive exudation, redness, swelling, heat, pain. Acute myocardial infarction, heart failure, hepatitis; Active bleeding or hematoma in the wound; Serum albumin <25g/L; Hemoglobin <80g/L; Platelets <50×109/L; Poor cooperate or compliance;The patient cannot cooperate or is. Mentally disabled.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Long Zhang, Dr.
Phone
+8613041210677
Email
longzh2000@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wen-Hui Wang, Dr.
Phone
+8618618269437
Email
wwh0608@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Long Zhang, Dr.
Organizational Affiliation
Peking University Third Hospital Wound Healing Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
long zhang, Dr.
Phone
13041210677
Email
longzh2000@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Umbilical Cord Blood Mononuclear Cell Gel in the Treatment of Refractory Diabetic Foot Ulcer

We'll reach out to this number within 24 hrs