The Role of Percutaneous Angioplasty in Ischemic Leg Ulcer Healing

University of Crete

Status: Completed

Conditions: Ischemic Foot Ulcers

Treatments: Procedure: Percutaneous transluminal angioplasty (PTA)

Study type: Interventional

Funder types: Other

Identifiers

NCT03057080

PTA1A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 161 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• newly diagnosed patients with ischemic foot ulcer and
• patients aged 18 years or older.

Exclusion criteria

• refusal to participate
• refusal of PTA therapy
• lesions not amenable to endovascular revascularization by vascular team's consensus based on preinterventional imaging
• absolute contraindication to contrast media injection, as determined by the investigator
• uncontrollable coagulopathy
• unwilling or unable to provide informed consent or return for required follow-up evaluations and
• previous or concurrent participation in another clinical research study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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161 participants in 1 patient group

PTA procedure

Other group

Description:

Percutaneous transluminal angioplasty (PTA) in patients with ischemic leg ulcer

Treatment:

Procedure: Percutaneous transluminal angioplasty (PTA)