The Role of Percutaneous Angioplasty in Ischemic Leg Ulcer Healing

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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Foot Ulcers
• Intervention / Treatment: Procedure: Percutaneous transluminal angioplasty (PTA)

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.

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PTA procedure; Percutaneous transluminal angioplasty (PTA) in patients with ischemic leg ulcer	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with ulcer healing	Number of patients with complete Ischemic leg ulcer healing defined as the complete epithelization of the lesion	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amputation free survival	Number of months without amputation	2 years
Number of patients with all-cause mortality	Number of patients with all-cause mortality after PTA	2 years
Number of participants with Major adverse events	Number of participants with Major adverse events from PTA	2 years
Number of patients with 30-day morbidity and mortality	30-day morbidity and mortality from PTA	30 days
Number of patients requiring re-intervention	umber of patients requiring PTA re-intervention	2 years

Collaborators and Investigators

• Sponsor: University of Crete
• Investigators: Study Chair: Dimitrios Tsetis, MD, PhD, University of Crete

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2009
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 12, 2017
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (Actual): February 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 17, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Foot Diseases; Foot Ulcer; Ulcer; Ischemia; Leg Ulcer
• Other Study ID Numbers: PTA1A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No