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

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: Diabetic Foot Ulcer
• Intervention / Treatment: Drug: Umbilical cord blood mononuclear cell gel（MNC）; Drug: The platelet rich plasma（PRP）

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

• Study Contact: Name: Long Zhang, Dr.; Phone Number: +8613041210677; Email: longzh2000@163.com
• 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: long zhang, Dr.; Phone Number: 13041210677; Email: longzh2000@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 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

How is the study designed?

Design Details

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

Number of Arms

2

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

Collaborators and Investigators

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

Study record dates

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: Diabetic Foot Ulcer; Umbilical cord blood mononuclear cells
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• 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