Transverse Tibial Bone Transport in "No Option" Patients With Chronic Limb-Threatening Ischemia: A Pilot Study
University Hospitals Cleveland Medical Center
Summary
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.
Eligibility
- Age range
- 18–95 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- ProcedureTransverse Tibial Bone Transport
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.
- DeviceTrueLok Elevate
This device is used to move the bone segment as a part of the tibial bone transport surgery.
Location
- University Hospitals Cleveland Medical CenterCleveland, Ohio