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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University Third Hospital

Criteria

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.