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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
Sponsor:
Information provided by (Responsible Party):
Izolde Bouloukaki, University of Crete

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.

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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

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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.




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



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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

Information from the National Library of Medicine

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


Sponsors and Collaborators
University of Crete
Investigators
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Study Chair: Dimitrios Tsetis, MD, PhD University of Crete
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Responsible Party: Izolde Bouloukaki, MD, PhD, University of Crete
ClinicalTrials.gov Identifier: NCT03057080    
Other Study ID Numbers: PTA1A
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Foot Ulcer
Leg Ulcer
Ischemia
Ulcer
Pathologic Processes
Foot Diseases
Skin Diseases
Skin Ulcer