The Role of Percutaneous Angioplasty in Ischemic Leg Ulcer Healing

NCT03057080 | Completed

• 1 other identifier: PTA1A
• Study Type: interventional
• Target: 161
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ischemic Foot Ulcers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Amputation free survival

  2 years

• Number of patients with all-cause mortality

  2 years

• Number of participants with Major adverse events

  2 years

• Number of patients with 30-day morbidity and mortality

  30 days

• Number of patients requiring re-intervention

  2 years

Study Arms (1)

PTA procedure

OTHER

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

Procedure: Percutaneous transluminal angioplasty (PTA)

Interventions

Percutaneous transluminal angioplasty (PTA) PROCEDURE

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.

PTA procedure

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Crete: lead

MeSH Terms

Interventions

Angioplasty

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Dimitrios Tsetis, MD, PhD

  University of Crete

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 12, 2017
• First Posted: February 17, 2017
• Study Start: June 1, 2009
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2016
• Last Updated: February 17, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share