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| Name | Class |
|---|---|
| Nanfang Hospital, Southern Medical University | OTHER |
| Academy Military Medical Science, China | INDUSTRY |
| The Fifth Affiliated Hospital of Southern Medical University | OTHER |
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Stem cell therapy has been a new and effective therapy in recent years for diabetic foot.This study intends to establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.
Diabetic foot is one of the most serious chronic complications of diabetic patients, and still lacking effective treatments.
Stem cell therapy has been a new and effective therapy in recent years for diabetic foot. Combined with the previous studies of our research group, this study intends to transform part of the results of this research, establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Bone Marrow Stem Cell | Experimental | Mesenchymal stem cells derived from bone marrow infusion |
|
| saline | Placebo Comparator | saline injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesenchymal stem cells | Biological | stem cell acquisition, processing and reinfection, to evaluate the efficacy by using autologous bone marrow stem cell |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area of diabetic foot ulcers | To determine the ability of MSC to facilitate and accelerate diabetic foot ulcers healing. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of transcutaneous oxygen partial pressure (TcPO2) | Improvement of local perfusion. | 3 months |
| Improvement of microvascular cutaneous reactivity by laser Doppler perfusion monitoring (LDPM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Shen | Contact | +86 13808893818 | shenjiedr@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jie Shen | The Third Affiliated Hospital of Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Third Affiliated Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D007511 | Ischemia |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Southern Medical University, China |
| OTHER |
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| saline | Biological | saline injections |
|
| 3 months |
| Pain (Visual-Analog Scale) | Measure of the subjective symptom of pain. | 3 months |
| Walking distance (treadmill) if possible | 3 months |
| D003925 | Diabetic Angiopathies |
| D016523 | Foot Ulcer |
| 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 |
| D017670 |
| Sodium Compounds |