The Role of Percutaneous Angioplasty in Ischemic Leg Ulcer Healing
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|ClinicalTrials.gov Identifier: NCT03057080|
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : February 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Foot Ulcers||Procedure: Percutaneous transluminal angioplasty (PTA)||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||161 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- Amputation free survival [ Time Frame: 2 years ]Number of months without amputation
- Number of patients with all-cause mortality [ Time Frame: 2 years ]Number of patients with all-cause mortality after PTA
- Number of participants with Major adverse events [ Time Frame: 2 years ]Number of participants with Major adverse events from PTA
- Number of patients with 30-day morbidity and mortality [ Time Frame: 30 days ]30-day morbidity and mortality from PTA
- Number of patients requiring re-intervention [ Time Frame: 2 years ]umber of patients requiring PTA re-intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057080
|Study Chair:||Dimitrios Tsetis, MD, PhD||University of Crete|