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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MNC+PRP | Experimental | The combination of PRP and MNC |
|
| PRP | Active Comparator | PRP alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical cord blood mononuclear cell gel(MNC) | Drug | Local wound treatment by combination of PRP and MNC, once; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound area reduction rate | The ratio of the reduced area after one week of treatment to the original area | one week |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing rate at 4 weeks | Percentage of patients with healed wound at 4 weeks | 4 weeks |
| Amputation rate at 8 weeks | Percentage of patients with major amputation at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Long Zhang, Dr. | Contact | +8613041210677 | longzh2000@163.com | |
| Wen-Hui Wang, Dr. | Contact | +8618618269437 | wwh0608@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Long Zhang, Dr. | Peking University Third Hospital Wound Healing Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
all IPD that underlie results in a publication
starting 6 months after publication, for 1 year
The IPD and supporting information will be shared by contact PI (Long Zhang)'s Email, upon the request of the scientific journal editor.
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| The platelet rich plasma(PRP) | Drug | Local wound treatment by PRP alone, once. |
|
|
| 8 weeks |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |