Transverse Tibial Bone Transport in "No Option" Patients With Chronic Limb-Threatening Ischemia: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percentage of patients achieving a decrease in the Rutherford classification measured by direct observation
研究概览
简要总结
Chronic limb-threatening ischemia (CLTI) is a serious condition that happens when blood flow to the legs or feet is severely reduced. This can lead to constant pain, wounds that don't heal, infections, and in some cases, the need for amputation.
Some people with CLTI have such severe artery disease that doctors are unable to restore blood flow using standard treatments like surgery or stents. For these patients, major amputation may be the only remaining option.
This study aims to test a new surgical technique called transverse tibial bone transport, which has been shown in some previous small studies to help improve blood flow and promote healing of wounds in the legs and feet. These early studies suggest that the procedure may help wounds heal better and reduce the need for amputation in people with severe circulation problems. This research will help us learn more about how safe and effective this technique is for patients who have no other treatment options other than amputation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18 years and under 95 years
- •History of diabetes mellitus with stable glycemic control (HbA1C<10)
- •Clinical diagnosis of chronic limb-threatening ischemia
- •Stable Rutherford Classification 5 or 6 ischemic ulcer on foot
- •Subjects who are determined by an independent multidisciplinary team of surgical and endovascular experts to have no feasible conventional distal bypass surgical or endovascular therapy for limb salvage.
- •Subjects who are enrolled in an appropriate wound care network and have a sufficient support system to ensure compliance with medication regimens and follow-up study visits.
- •Subjects who are willing and able to provide informed consent
排除标准
- •Frailty or severe comorbidities including significantly reduced cardiac, hepatic, renal and respiratory insufficiency making the subject not fit for surgery
- •Active malignancy or immunodeficiency disorder
- •Previous major amputation of the target limb or presence of a wound requiring a free flap
- •Life expectancy less than 12 months
- •Active infection at the time of the index procedure
- •Any significant concurrent medical, psychological, or social condition that, in the opinion of the investigator, may substantially interfere with the subject's optimal participation in the study.
- •Pregnancy at the time of enrolment
- •The subject participating in another investigational drug or device study that has not completed its primary endpoint or clinically interferes with the endpoints of this study.
- •The subject is unwilling or unable to comply with any protocol or follow-up requirements.
研究组 & 干预措施
Transverse Tibial Bone Transport Patients
Patients in this arm will undergo transverse tibial bone transport
干预措施: Transverse Tibial Bone Transport (Procedure)
Transverse Tibial Bone Transport Patients
Patients in this arm will undergo transverse tibial bone transport
干预措施: TrueLok Elevate (Device)
结局指标
主要结局
Percentage of patients achieving a decrease in the Rutherford classification measured by direct observation
时间窗: Up to 6 months post surgery
The Rutherford wound classification is an observational technique to assess the severity of peripheral artery disease of the lower limb on a scale of 0 being asymptomatic to 6 being major tissue loss.
Changes in lower extremity arterial perfusion measured by ankle-brachial index and toe-brachial index
时间窗: 1 month, 3 months, and 6 months post surgery
The Ankle-Brachial Index (ABI) and Toe-Brachial Index (TBI) are noninvasive measures of lower-extremity arterial perfusion, calculated as the ratio of the highest systolic blood pressure at the ankle or great toe, respectively, to the highest systolic blood pressure at the brachial artery. Lower ABI and TBI values on indicate greater arterial obstruction.
Percentage of patients avoiding major amputation
时间窗: Up to 6 months post surgery
major amputation refers to the surgical removal of a limb anywhere above the ankle joint
Percentage of patients achieving complete wound healing as measured by the direct wound observation
时间窗: Up to 6 months post surgery
Percentage of patients avoiding major amputation
时间窗: Up to 6 months post surgery
major amputation refers to the surgical removal of a limb anywhere above the ankle joint
Percentage of patients achieving complete wound healing as measured by the direct wound observation
时间窗: Up to 6 months post surgery
Percentage of patients achieving a decrease in the Rutherford classification measured by direct observation
时间窗: Up to 6 months post surgery
The Rutherford wound classification is an observational technique to assess the severity of peripheral artery disease of the lower limb on a scale of 0 being asymptomatic to 6 being major tissue loss.
Changes in lower extremity arterial perfusion measured by ankle-brachial index and toe-brachial index
时间窗: 1 month, 3 months, and 6 months post surgery
The Ankle-Brachial Index (ABI) and Toe-Brachial Index (TBI) are noninvasive measures of lower-extremity arterial perfusion, calculated as the ratio of the highest systolic blood pressure at the ankle or great toe, respectively, to the highest systolic blood pressure at the brachial artery. Lower ABI and TBI values on indicate greater arterial obstruction.
次要结局
- Changes in pain measured by the Visual Analog Scale(1 week, 2 weeks, 1 month, 2 months, 3 months, and 6 months post surgery)
- Changes in lower extremity neuropathy measured by Semmes-Weinstein Monofilament Test(1 week, 2 weeks, 1 month, 2 months, 3 months, and 6 months post surgery)
- Changes in quality of life measured by the Short Form-36 (SF-36) scores(1 month, 2 months, 3 months, and 6 months post surgery)
- Percentage of patients experiencing adverse outcomes(Up to 6 months post surgery)
- Changes in pain measured by the Visual Analog Scale(1 week, 2 weeks, 1 month, 2 months, 3 months, and 6 months post surgery)
- Changes in lower extremity neuropathy measured by Semmes-Weinstein Monofilament Test(1 week, 2 weeks, 1 month, 2 months, 3 months, and 6 months post surgery)
- Changes in quality of life measured by the Short Form-36 (SF-36) scores(1 month, 2 months, 3 months, and 6 months post surgery)
- Percentage of patients experiencing adverse outcomes(Up to 6 months post surgery)
研究者
Mehdi Shishehbor, MD
President, University Hospitals Harrington Heart and Vascular Institute
University Hospitals Cleveland Medical Center