NCT03057080

The Role of Percutaneous Angioplasty in Ischemic Leg Ulcer Healing

Peripheral Angioplasty as the First Choice Revascularization Procedure to Promote Ischemic Leg Ulcer Healing

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: University of Crete · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The aim of our study was to evaluate the technical and clinical effectiveness of PTA in the management of ischemic foot ulcers. All consecutive patients presenting with a foot ulcer at the outpatient Vascular surgery clinic of our hospital were evaluated. If non-invasive parameters suggested peripheral arterial disease (PAD) anatomic imaging (CTA and/or DSA) was performed and a PTA was carried out when feasible during the same session. All patients were followed until healing, amputation, death, or for at least two years. Short-term and long-term clinical success of PTA was evaluated based on ulcer size and appearance. Patients with worsening ulcers after PTA underwent bypass grafting or amputation.

Detailed description

The aim of our study was to evaluate the technical and clinical effectiveness of PTA in the management of ischemic foot ulcers. Methods: All consecutive patients presenting with a foot ulcer at the outpatient Vascular surgery clinic of our hospital were evaluated. Preoperative evaluation included foot pulse assessment, ankle-brachial-index (ABI) and duplex scanning. If non-invasive parameters suggested peripheral arterial disease (PAD) anatomic imaging (CTA and/or DSA) was performed and a PTA was carried out when feasible during the same session. All patients were followed until healing, amputation, death, or for at least two years. Short-term and long-term clinical success of PTA was evaluated based on ulcer size and appearance. Patients with worsening ulcers after PTA underwent bypass grafting or amputation.

Conditions

• Ischemic Foot Ulcers

Interventions

Type	Name	Description
PROCEDURE	Percutaneous transluminal angioplasty (PTA)	The main goal of the angioplasty (which was also the definition of technical success) was to achieve straight-line flow (SLF) from the aorta down to either a patent dorsalis pedis or plantar arch.

Timeline

• Start date: 2009-06-01
• Primary completion: 2015-06-01
• Completion: 2016-12-01
• First posted: 2017-02-17
• Last updated: 2017-02-17