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

Diabetic Foot Ulcer Clinical Trial

— DFU-MNC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04689425
• Other study ID #: Long2020-DFU-MNC
• Status: Recruiting
• Phase: Phase 3
• Start date: March 30, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2022
• Source: Peking University Third Hospital
• Contact: Long Zhang, Dr.
• Phone: +8613041210677
• Email: longzh2000[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. The age of the patients is 18-80 years old;

2. Diabetic foot is diagnosed and Wagner grade is above ?;

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Drug:
• Umbilical cord blood mononuclear cell gel(MNC)
Local wound treatment by combination of PRP and MNC, once;
• The platelet rich plasma(PRP)
Local wound treatment by PRP alone, once.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound area reduction rate	The ratio of the reduced area after one week of treatment to the original area	one week
Secondary	Wound healing rate at 4 weeks	Percentage of patients with healed wound at 4 weeks	4 weeks
Secondary	Amputation rate at 8 weeks	Percentage of patients with major amputation at 8 weeks	8 weeks