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

Peking University

Status and phase: Enrolling; Phase 3

Conditions: Diabetic Foot Ulcer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04689425

Long2020-DFU-MNC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups

MNC+PRP

Experimental group

Description:

The combination of PRP and MNC

Treatment:

Drug: Umbilical cord blood mononuclear cell gel（MNC）

Drug: The platelet rich plasma（PRP）

PRP

Active Comparator group

Description:

PRP alone.

Treatment:

Drug: The platelet rich plasma（PRP）