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This cohort study aims to evaluate the outcomes of appropriate surgical treatment strategies in diabetic foot ulcers with different rate of popliteal artery stenosis(<50% or ≥50%). In this study, patients with Texas university grade 2-4(stage C-D) ischemic diabetic foot ulcers will be included. Data of patients who underwent surgical treatment in the past will be retrospectively collected. The patients with follow-up time less than 12 months will continue to follow up. Also the postoperative patients will be prospectively collected. Effects of different surgical strategies, including wound healing therapy, interventional therapy and tibial transverse bone transport therapy will be measured by several indexes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rate of popliteal artery stenosis < 50%, W. | Other | If the rate of popliteal artery stenosis of patients < 50%, the patients only receive the wound treatment. |
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| Rate of popliteal artery stenosis < 50%, WT. | Other | If the rate of popliteal artery stenosis of patients < 50%, the patients receive the wound treatment and tibial transverse transport surgery. |
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| Rate of popliteal artery stenosis ≥ 50%, WV. | Other | If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment and vascular intervention surgery. |
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| Rate of popliteal artery stenosis ≥ 50%, WT. | Other | If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment and tibial transverse transport surgery. |
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| Rate of popliteal artery stenosis ≥ 50%, WVT. | Other | If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment, vascular intervention and tibial transverse transport surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wound treatment | Procedure | According to the guidelines and recommendations of the International Diabetic Foot Working Group, ulcer surface debridement, negative pressure suction drainage, and routine dressing were performed until the wound healed or the end of the trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Healing rate of wound surface | 12 months after surgical operation |
| Measure | Description | Time Frame |
|---|---|---|
| Ankle-brachial index | 3 months after surgical operation | |
| Ankle-brachial index | 12 months after surgical operation | |
| Recurrence rate of foot ulcer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yusong Yuan, Master | Contact | +86 18801229862 | xiaxi@pku.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hailin Xu, MD | Peking University People's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | 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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| Vascular intervention surgery | Procedure | Segmented distal angiography under the guidance of digital subtraction angiography (DSA) were perform after local anesthesia. The superficial artery is expanded by a 3-4 mm balloon. |
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| Tibial transverse transport surgery | Procedure | In the anteromedial area of the proximal tibia of the affected limb, the external fixation frame was compared with the area along the midline of the medial longitudinal axis of the proximal tibia. Subsequently, two 3.0 Steinmann pins were inserted through the single layer of cortical bone. The skin was cut along the long axis with the 3.0 Steinmann pin as the centre, and the subcutaneous tissue was separate bluntly to expose the periosteum. The Steinmann pins were used as the centre point for the drilling on four sides with a 2.0 drill bit and use of a rapid osteotomy device; the length of each side was 2.5 cm. Subperiosteal osteotomy was performed with a 5-mm narrow bone knife at an angle of 15°-30° to the bone surface. The surgeons should pay attention to protect the blood supply of the periosteum during this procedure. The external fixators were fixed with 4.0 Steinmann pins at the distal and proximal ends. The subcutaneous tissue and skin were sutured. |
|
| 12 months after surgical operation |
| 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 |