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NCT Number: NCT07488637

Woundsome Revascularization in Chronic Limb-Threatening Ischemia

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vascular and Endovascular surgery department Assiut university

Asyut, Asyut Governorate, 71511, Egypt

Location contact

Andrew Wageeh Resident doctor, Master's degree

CONTACT

[email protected]

+201149193361

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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Exclusion criteria

  • 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

Treatment and study plan

Revascularization by Percutaneous Transluminal Angioplasty

Procedure

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 outcomes

  1. Limb Salvage

    Time frame: 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)

    To assess the rate of limb salvage following woundsome-guided revascularization in patients with chronic limb-threatening ischemia.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Wageeh Latif Resident Doctor, Master's degree

CONTACT

[email protected]

+201149193361

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 23, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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