NCT04689425

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DRUG	Umbilical cord blood mononuclear cell gel（MNC）	Local wound treatment by combination of PRP and MNC, once;
DRUG	The platelet rich plasma（PRP）	Local wound treatment by PRP alone, once.

Timeline

• Start date: 2021-03-30
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2020-12-30
• Last updated: 2022-09-29

Locations

1 site across 1 country: China