Woundsome Revascularization in Chronic Limb-Threatening Ischemia

ConditionChronic Limb-Threatening Ischemia

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAssiut University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patients with unsalvageable limbs

Patients with acute limb ischemia (ALI)

Patients with contraindications to contrast medium

Patients with aortoiliac or femoropopliteal occlusive disease

Trial design

Design model

Single group

Treatments tested in this trial

Revascularization by Percutaneous Transluminal Angioplasty
Procedure/Surgery
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.

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: Woundsome-Guided RevascularizationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Limb Salvage

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

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)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: