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| Name | Class |
|---|---|
| Second Affiliated Hospital of Nantong University | OTHER |
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With a rapidly growing incidence rate and a high disability rate,The Diabetic Foot has long been difficult to treatment, which has caused a huge burden to patients and society. The blood supply disorder is one of the main reasons that lead to the morbidity and difficulty in healing of diabetes feet, but there is still a lack of particularly effective treatment to improve the blood supply of diabetes feet. Both transverse bone transport and bone marrow cell transplantation have shown some clinical effects. However, the difference in efficacy between the two has not been reported. In this study, investigators compared the therapeutic effects of these two methods on the healing of diabetes foot ulcers through a controlled clinical study.
In this study, investigators compared the therapeutic effects of Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion on the healing of diabetes foot ulcers through a controlled clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tibial Transportation | Active Comparator | Tibial Transportation |
|
| Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion | Experimental | Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion | Procedure | transverse bone transport with bone marrow cell transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| visual analogue scale | Visual analog scale (VAS) and its corresponding visual analog pain scale, is a psychometric scale that is generally used in hospitals and clinics by doctors to conduct pain scale surveys to understand varying degrees of pain or discomfort experienced by a patient.VAS ranges from 0 to 10 and a higher score means worse outcome. | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| ulcer area | ulcer area will be record in cm2. Use a digital camera to photograph each chronic skin ulcer wound at a fixed height and angle, and use a ruler as a marker. Each photo was measured 3 times using NIH ImageJ software and analyzed using a ruler as a scale. Import the pictures collected by the digital camera into the computer, select the clearest picture, apply the NIH ImageJ software, use a tracer pen to sketch the contour of the ulcer surface along the edge of the ulcer, and obtain the pixel square value. At the same time, use a tracer pen to sketch the linear distance of 1 cm on the scale, to obtain the pixel value of 1 cm linear distance, and then multiply the pixel value of 1 cm to obtain. The pixel square value of 1 cm2 is divided by the pixel square value of the ulcer surface contour to obtain the chronic ulcer skin area. |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qinglin Han, Dr | Contact | +8651385052222 | qlhan2013@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qinglin Han, Dr | Affiliated Hospital of Nantong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated hospital of nantong university | Recruiting | Nantong | Jiangsu | 226001 | 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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| Tibial Transportation | Procedure | transverse bone transport |
|
| 3 months after surgery |
| Wagner grade | The Wagner Diabetic Foot Ulcer Grade Classification System. The Wagner diabetic foot ulcer classification system assesses ulcer depth and the presence of osteomyelitis or gangrene by using the following grades.Wagner grade ranges from 0 to 10 and a higher score means worse outcome. | 3 months after surgery |
| Painless walking distance | Painless walking distance | 3 months after surgery |
| Ankle brachial index | a simple test that compares the blood pressure in the upper and lower limbs | 3 months after surgery |
| skin temperature | skin temperature | day after surgery |
| 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 |