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To investigate the treatment effect between Traditional treatment and transplantation of autologous PRG combined with autologous BMMSCs for treatment of diabetic foot ulcer.
60 diabetic foot ulcer in our hospital will divide into 3 groups: group A (20 diabetic foot ulcer who give Traditional treatment), group B (20 diabetic foot ulcer who give Traditional treatment and transplantation of autologous platelet rich gel),group C (20 diabetic foot ulcer who give Traditional treatment and transplantation of autologous platelet rich gel combined with autologous bone marrow mesenchymal stem cells). The age, height, weight, blood glucose, glycosylated hemoglobin A1c(HbA1c), lipid, blood pressure, course of disease, Wound healing rate,transcutaneous oxygen pressure,Amputation rate,Hospital stay will record respectively. And High-sensitive C-reactive protein (HsCRP) and Tumor necrosis factor-α(TNF-α) will detect as Baseline. After each group's treatment, Change from baseline of all indexes will record, one way Analysis of Variance will be analyzed the significantion among 3 groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional treatment | Placebo Comparator | Traditional treatment such as insulin,antidiabetes,dressing |
|
| PRG combined with BMMSCs transplantation | Experimental | Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG combined with BMMSCs |
|
| PRG treatment | No Intervention | Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRG combined with BMMSCs transplantation | Biological | PRG combined with BMMSCs transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amputation rate | Amputation rate up to 6 months | up to 6 months |
| hospital stay | hospital stay | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing time | Wound healing time | up to 6 months |
| Transcutaneous oxygen partial pressure | Transcutaneous oxygen partial pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Hospital of the Third Military Medical University | Recruiting | Chongqing | Chongqing Municipality | +86 | China |
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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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diabetic foot ulcer which Wagner classification at 2-3 grade.
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|
| Transcutaneous oxygen partial pressure up to 6 months |
| Endocrine Department, the First Affiliated Hospital of the Third Military Medical University | Recruiting | Chongqing | Chongqing Municipality | 400038 | China |
|
| 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 |