The Role of Glass Stage Compared to WIFI Stage in Predicting Limb Salvage

Not yet recruiting

• Conditions: Chronic Limb-Threatening Ischemia

• Registration Number: NCT06209866
• Lead Sponsor: Assiut University

Brief Summary

compare between GLASS and WIFI Staging in predicting limb salvage in patients with chronic limb threatening ischemia ( CLTI) undergoing endovascular revascularization.

Detailed Description

Peripheral arterial disease (PAD) is estimated to affect over 200 million people worldwide. These rates are expected to rise as increasing life expectancies continue to shift the population toward older age. At the most severe end of the disease spectrum, chronic limb-threatening ischemia (CLTI) affects 11% of patients with PAD and is associated with high rates of limb loss and mortality as well as high costs of care.(1) The Society for Vascular Surgery's WIfI (Wound, Ischemia, foot Infection) staging system was developed to classify threatened limbs using factors that affect amputation risk and clinical management in patients with chronic limb threatening ischemia . These include the extent of the wound, degree of ischemia, and severity of any foot infection. It has been validated as a predictor of limb salvage in peripheral artery disease.(2,3)

The Global Vascular guidelines 'GVG "proposes a new Global Anatomic Staging System (GLASS), which is a new method of quantifying the anatomic severity of infrainguinal disease in patients with chronic limb-threatening ischemia. But it has not been used for predicting limb salvage apart from use as a tool in deciding the mode of intervention for patients with chronic limb-threatening ischemia (CLTI).

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-06
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-18
• Last Update Submitted: 2024-01-20
• Last Update Posted: 2024-01-23
• Study Start: 2024-02-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Patients with CLTI who will undergo endovascular revascularization at our department:

• Rutherford stage 4 ( rest pain) ,stage 5 (ischemic ulceration not exceeding ulcer of the digits of the foot) , stage 6 ( severe ischemic ulcers or frank gangrene)

Exclusion Criteria

• Rutherford stage 1,2,3 Aortoiliac level of occlusion Unsalvageable limb Patients with contraindications to contrast media Non Atherosclerotic lschemia as • Acute ischemia

  • Post Traumatic Ischemia
  • Chronic ischemia caused by connective tissue diseases or vasculitis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical Success	Baseline	in - line arterial flow to the foot without any flow limiting dissection or residual stenosis \> 30% on completion intraoperative arteriography
Limb Salvage	Baseline	freedom from major amputation above the foot level
Primary Patency	Baseline	uninterrupted vessel patency with no procedure performed on the treated limb.
Time to complete healing	Baseline	Time to complete healing of the wound after revascularization, Debridement or minor amputation
Secondary Patency	Baseline	an occluded artery that required intervention to restore patency.
Assisted Primary Patency	Baseline	the percentage of failing but still patent vessel undergoing elective intervention, included patients required revision of the revascularization before vessel occlusion occurs as prophylactic interventions to maintain patency.