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Woundsome Revascularization in Chronic Limb-Threatening Ischemia

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07488637
Enrollment
50
Registered
2026-03-23
Start date
2026-04-01
Completion date
2027-10-01
Last updated
2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Limb-Threatening Ischemia

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 instead on improving arterial perfusion directly to the wound area, recognizing that both direct revascularization and

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. Recent vascular guidelines acknowledge limitations in incorporating terminal circulation into treatment algorithms. The angiosome concept describes six angiosomes in the foot and ankle supplied by the three main infrapopliteal arteries and was proposed as a method to guide revascularization and ensure direct blood flow to affected tissues. However, its utility is limited by variations in anatomy, the presence of collateral circulation, and the contribution of vessels such as branches of the peroneal artery. The condition of the pedal arch also plays an important role. Additionally, larger wounds often involve more than one angiosome, which complicates the application of this concept. The "woundsome" concept has therefore emerged, emphasizing targeted improvement of arterial blood flow directly to the wound area in patients with CLTI and tissue loss. Evidence suggests that direct arterial perfusion to the wound is associated with better outcomes in limb salvage and wound healing. At the same time, the presence and quality of collateral circulation following indirect revascularization can also significantly influence clinical success and may provide outcomes comparable to direct revascularization.

Interventions

PROCEDURERevascularization 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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

1. Patients with unsalvageable limbs 2. Patients with acute limb ischemia (ALI) 3. 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) 4. Patients with contraindications to contrast medium 5. Patients with aortoiliac or femoropopliteal occlusive disease

Design outcomes

Primary

MeasureTime frameDescription
Limb SalvageLimb 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)To assess the rate of limb salvage following woundsome-guided revascularization in patients with chronic limb-threatening ischemia.

Countries

Egypt

Contacts

CONTACTAndrew Wageeh Latif Resident Doctor, Master's degree
andrewwageeh49@gmail.com+201149193361
STUDY_DIRECTORMahmoud Ismael Ahmed Saleh, PHD

Vascular and Endovascular surgery department Assiut University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026