The Role of Percutaneous Angioplasty in Ischemic Leg Ulcer Healing

• ClinicalTrials.gov Identifier: NCT03057080
• Recruitment Status: Completed
• First Posted: February 17, 2017
• Last Update Posted: February 17, 2017
• Sponsor: University of Crete
• Information provided by (Responsible Party): Izolde Bouloukaki, University of Crete

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ischemic Foot Ulcers	Procedure: Percutaneous transluminal angioplasty (PTA)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 161 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Peripheral Angioplasty as the First Choice Revascularization Procedure to Promote Ischemic Leg Ulcer Healing
• Actual Study Start Date: June 1, 2009
• Actual Primary Completion Date: June 1, 2015
• Actual Study Completion Date: December 1, 2016

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Number of patients with ulcer healing [ Time Frame: 2 years ]
   Number of patients with complete Ischemic leg ulcer healing defined as the complete epithelization of the lesion

Secondary Outcome Measures :

1. Amputation free survival [ Time Frame: 2 years ]
   Number of months without amputation
2. Number of patients with all-cause mortality [ Time Frame: 2 years ]
   Number of patients with all-cause mortality after PTA
3. Number of participants with Major adverse events [ Time Frame: 2 years ]
   Number of participants with Major adverse events from PTA
4. Number of patients with 30-day morbidity and mortality [ Time Frame: 30 days ]
   30-day morbidity and mortality from PTA
5. Number of patients requiring re-intervention [ Time Frame: 2 years ]
   umber of patients requiring PTA re-intervention

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Sponsors and Collaborators

University of Crete

Investigators

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

More Information

• Responsible Party: Izolde Bouloukaki, MD, PhD, University of Crete
• ClinicalTrials.gov Identifier: NCT03057080
• Other Study ID Numbers: PTA1A
• First Posted: February 17, 2017
• Last Update Posted: February 17, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Foot Ulcer; Leg Ulcer; Ischemia; Ulcer; Pathologic Processes; Foot Diseases; Skin Diseases; Skin Ulcer