A Phase 3 interventional study of Umbilical cord blood mononuclear cell gel（MNC） and The platelet rich plasma（PRP） in Diabetic Foot Ulcer, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-09-29.
Sponsored by Peking University Third Hospital · Phase 3, Interventional, and Treatment
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.
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.
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Exclusion Criteria:
The combination of PRP and MNC
Drug: Umbilical cord blood mononuclear cell gel（MNC） · Drug: The platelet rich plasma（PRP）
PRP alone.
Drug: The platelet rich plasma（PRP）
Local wound treatment by combination of PRP and MNC, once;
Also known as: MNC+PRP
Local wound treatment by PRP alone, once.
Also known as: PRP
Wound area reduction rate
The ratio of the reduced area after one week of treatment to the original area
Time frame: one week
Wound healing rate at 4 weeks
Percentage of patients with healed wound at 4 weeks
Time frame: 4 weeks
Amputation rate at 8 weeks
Percentage of patients with major amputation at 8 weeks
Time frame: 8 weeks
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Peking University Third Hospital