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Woundsome Revascularization in Chronic Limb-Threatening Ischemia 50

Not yet recruiting
Clinical Trial NCT07488637 is an interventional study for Chronic Limb-Threatening Ischemia and is currently not yet recruiting. Enrollment is planned to begin on 1 April 2026 and continue until the study accrues 50 participants. Led by Assiut University, this study is expected to complete by 1 October 2027. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
Brief Summary
Chronic limb-threatening ischemia (CLTI) is the most severe form of peripheral artery disease and remains a major health problem. Although the angiosome concept was introduced to guide revascularization by restoring direct blood flow to the affected tissue, its usefulness is limited by anatomical variations, collateral circulation, and wounds involving multiple territories. The emerging "woundsome" concept focuses in...Show More
Detailed Description
Chronic limb-threatening ischemia (CLTI) represents the most advanced stage of lower-extremity peripheral artery disease and is a major global health concern with increasing prevalence and significant health-care costs. Technological advancements, evolving revascularization strategies, and improved surgical and endovascular expertise have reduced the number of patients considered unsuitable for revascularization. Rec...Show More
Official Title

Impact of Woundsome Revascularization on the Outcomes of Endovascular Intervention in Patients With Chronic Limb-Threatening Ischemia

Conditions
Chronic Limb-Threatening Ischemia
Other Study IDs
  • Woundsome_Revascularization
NCT ID Number
NCT07488637
Start Date (Actual)
2026-04-01
Last Update Posted
2026-03-25
Completion Date (Estimated)
2027-10-01
Enrollment (Estimated)
50
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Prevention
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalWoundsome-Guided Revascularization
Revascularization strategy directed toward restoring arterial blood flow specifically to the wound location (woundsome). Target vessel selection is based on the artery most likely to provide direct perfusion to the wound area, considering anatomical variations, collateral circulation, and pedal arch patency, rather than relying solely on the traditional angiosome-based approach.
Revascularization by Percutaneous Transluminal Angioplasty
Endovascular revascularization is performed under fluoroscopic guidance using femoral artery access. Balloon angioplasty targets infrapopliteal vessels supplying direct blood flow to the wound. Post-procedure angiography assesses wound perfusion (woundsome), and patients are classified as having successful or unsuccessful woundsome revascularization based on contrast opacification around the wound.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Limb Salvage
To assess the rate of limb salvage following woundsome-guided revascularization in patients with chronic limb-threatening ischemia.
Limb salvage will be assessed during follow-up for 12 months after woundsome revascularization. All patients will be scheduled for follow-up visits every 6 months for 1 year (0, 6, 12 months)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

Patients with chronic limb-threatening ischemia (CLTI) with tissue loss (Rutherford Class 5 or 6, or WIFI stage 2-4) Patients with infrapopliteal arterial occlusions requiring revascularization

-

Patients with unsalvageable limbs Patients with acute limb ischemia (ALI)

Patients with non-atherosclerotic diseases such as vasculitis, including:

Large vessel vasculitis (e.g., giant cell arteritis, Takayasu arteritis) Medium vessel vasculitis (e.g., polyarteritis nodosa, Kawasaki disease) Small vessel vasculitis (e.g., granulomatosis with polyangiitis, microscopic polyangiitis) Other types (e.g., Behçet's disease, Buerger's disease) Patients with contraindications to contrast medium Patients with aortoiliac or femoropopliteal occlusive disease

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Study Responsible Party
Andrew Wageeh Latif, Principal Investigator, Resident Doctor, Assiut University
Study Central Contact
Contact: Andrew Wageeh Latif Resident Doctor, Master's degree, +201149193361, [email protected]
1 Study Locations in 1 Countries

Asyut Governorate

Vascular and Endovascular surgery department Assiut university, Asyut, Asyut Governorate, 71511, Egypt
Andrew Wageeh Resident doctor, Master's degree, Contact, +201149193361, [email protected]