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

NCT04689425 | Unknown Phase 3 DMC

• 1 other identifier: Long2020-DFU-MNC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer

Keywords

Diabetic Foot Ulcer; Umbilical cord blood mononuclear cells

Outcome Measures

Primary Outcomes (1)

• Wound area reduction rate

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

  one week

Secondary Outcomes (2)

• Wound healing rate at 4 weeks

  4 weeks

• Amputation rate at 8 weeks

  8 weeks

Study Arms (2)

MNC+PRP

EXPERIMENTAL

The combination of PRP and MNC

Drug: Umbilical cord blood mononuclear cell gel（MNC）; Drug: The platelet rich plasma（PRP）

PRP

ACTIVE COMPARATOR

PRP alone.

Drug: The platelet rich plasma（PRP）

Interventions

Umbilical cord blood mononuclear cell gel（MNC） DRUG

Local wound treatment by combination of PRP and MNC, once;

Also known as: MNC+PRP

MNC+PRP

The platelet rich plasma（PRP） DRUG

Local wound treatment by PRP alone, once.

Also known as: PRP

MNC+PRP; PRP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Long Zhang, Dr.

  Peking University Third Hospital Wound Healing Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Long Zhang, Dr.

CONTACT

+8613041210677; longzh2000@163.com

Wen-Hui Wang, Dr.

CONTACT

+8618618269437; wwh0608@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Surgeon

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: December 30, 2020
• Study Start: March 30, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

CN (1)