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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
Tibial tibial bone transport is a novel surgical procedure that involves the gradual movement of a bone segment in order to improve perfusion and tissue healing.
This device is used to move the bone segment as a part of the tibial bone transport surgery.
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
RECRUITINGPercentage of patients avoiding major amputation
major amputation refers to the surgical removal of a limb anywhere above the ankle joint
Time frame: Up to 6 months post surgery
Percentage of patients achieving complete wound healing as measured by the direct wound observation
Time frame: Up to 6 months post surgery
Percentage of patients achieving a decrease in the Rutherford classification measured by direct observation
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.
Time frame: Up to 6 months post surgery
Changes in lower extremity arterial perfusion measured by ankle-brachial index and toe-brachial index
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.
Time frame: 1 month, 3 months, and 6 months post surgery
Changes in pain measured by the Visual Analog Scale
The Visual Analogue Scale (VAS) is a simple tool used to measure the intensity of pain. It typically consists of a 100 mm horizontal line anchored by two extremes, such as "No pain" on the left and "Worst imaginable pain" on the right. Participants mark a point along the line that best represents their experience, and the distance from the "no pain" end to the mark is measured in millimeters to produce a score from 0 to 100.
Time frame: 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
The Semmes-Weinstein Monofilament Test is a standardized assessment of light touch and protective sensation using calibrated nylon filaments, with inability to perceive the 10-gram (5.07) monofilament at specified sites indicating loss of protective sensation.
Time frame: 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
The Short Form-36 (SF-36) Health Survey is a validated 36-item questionnaire assessing eight domains of health-related quality of life, with scores for each domain ranging from 0 to 100, where higher scores indicate better perceived health status.
Time frame: 1 month, 2 months, 3 months, and 6 months post surgery
Percentage of patients experiencing adverse outcomes
All adverse outcomes and complications directly attributable to the transverse tibial bone transport procedure.
Time frame: Up to 6 months post surgery
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