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

Phase 3

Recruiting

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

• Registration Number: NCT04689425
• Lead Sponsor: Peking University Third Hospital

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.

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 Timeline

• Study First Submitted: 2020-12-24
• Study First Submitted QC: 2020-12-24
• Study First Posted: 2020-12-30
• Study Start: 2021-03-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-09-29
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MNC+PRP	The platelet rich plasma（PRP）	The combination of PRP and MNC
MNC+PRP	Umbilical cord blood mononuclear cell gel（MNC）	The combination of PRP and MNC
PRP	The platelet rich plasma（PRP）	PRP alone.

Primary Outcome Measures

Name	Time	Method
Wound area reduction rate	one week	The ratio of the reduced area after one week of treatment to the original area

Secondary Outcome Measures

Name	Time	Method
Wound healing rate at 4 weeks	4 weeks	Percentage of patients with healed wound at 4 weeks
Amputation rate at 8 weeks	8 weeks	Percentage of patients with major amputation at 8 weeks

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China