Woundsome Revascularization in Chronic Limb-Threatening Ischemia

Impact of Woundsome Revascularization on the Outcomes of Endovascular Intervention in Patients With 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

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Limb-Threatening Ischemia
• Intervention / Treatment: Procedure: Revascularization by Percutaneous Transluminal Angioplasty

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew Wageeh Latif Resident Doctor, Master's degree; Phone Number: +201149193361; Email: andrewwageeh49@gmail.com

Study Locations

• Egypt
  • Asyut Governorate
    • Asyut, Asyut Governorate, Egypt, 71511
      • Vascular and Endovascular surgery department Assiut university
      • Contact: Andrew Wageeh Resident doctor, Master's degree; Phone Number: +201149193361; Email: andrewwageeh49@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

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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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Woundsome-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.

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time 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)

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Mahmoud Ismael Ahmed Saleh, PHD, Vascular and Endovascular surgery department Assiut university

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Ischemia; Peripheral Arterial Disease; Pathological Conditions, Signs and Symptoms; Chronic Limb-Threatening Ischemia
• Other Study ID Numbers: Woundsome_Revascularization

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No