Woundsome Revascularization in Chronic Limb-Threatening Ischemia

NCT07488637 | Not Yet Recruiting DMC

• 1 other identifier: Woundsome_Revascularization
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Limb-Threatening Ischemia

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Woundsome-Guided Revascularization

EXPERIMENTAL

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

Interventions

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.

Woundsome-Guided Revascularization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Vascular and Endovascular surgery department Assiut university

Asyut, Asyut Governorate, 71511, Egypt

Location

Related Links

• Related Info

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Mahmoud Ismael Ahmed Saleh, PHD

  Vascular and Endovascular surgery department Assiut University

  STUDY DIRECTOR

Central Study Contacts

Andrew Wageeh Latif Resident Doctor, Master's degree

CONTACT

+201149193361; andrewwageeh49@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)