Ischemic Foot UlcersNCT03057080
The Role of Percutaneous Angioplasty in Ischemic Leg Ulcer Healing
A study testing Percutaneous transluminal angioplasty (PTA) in people with Ischemic Foot Ulcers, run by University of Crete.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ischemic Foot Ulcers
- What is being tested?
- Percutaneous transluminal angioplasty (PTA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2009to 1 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- newly diagnosed patients with ischemic foot ulcer and
- patients aged 18 years or older.
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Foot Ulcers
- Being tested
- Percutaneous transluminal angioplasty (PTA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous transluminal angioplasty (PTA)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| PTA procedure | Other | Percutaneous transluminal angioplasty (PTA) in patients with ischemic leg ulcer Receives: Procedure: Percutaneous transluminal angioplasty (PTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with ulcer healing
Number of patients with complete Ischemic leg ulcer healing defined as the complete epithelization of the lesion
Measured: 2 years
Secondary outcomes (5)
Amputation free survival
Number of months without amputation
Measured: 2 years
Number of patients with all-cause mortality
Number of patients with all-cause mortality after PTA
Measured: 2 years
Number of participants with Major adverse events
Number of participants with Major adverse events from PTA
Measured: 2 years
Number of patients with 30-day morbidity and mortality
30-day morbidity and mortality from PTA
Measured: 30 days
Number of patients requiring re-intervention
umber of patients requiring PTA re-intervention
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start1 Jun 2009
- Primary completion1 Jun 2015
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Foot UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Crete
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Izolde Bouloukaki, University of Crete
- Investigators
- Dimitrios Tsetis, MD, PhD, Study chair, University of Crete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057080
- Sponsor's protocol ID
- PTA1A
- Status last verified
- Feb 2017
- First submitted
- 12 Feb 2017
- Last updated
- 17 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Angioplasty as the First Choice Revascularization Procedure to Promote Ischemic Leg Ulcer Healing
- ClinicalTrials.gov ID
- NCT03057080
- Acronym / sponsor ID
- PTA1A
- Conditions
- Ischemic Foot Ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of CreteUniversity, hospital or other
- Study start
- 1 Jun 2009 (actual)
- Primary completion
- 1 Jun 2015 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 17 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTA procedure | Other | Procedure: Percutaneous transluminal angioplasty (PTA)Percutaneous transluminal angioplasty (PTA) in patients with ischemic leg ulcer |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- newly diagnosed patients with ischemic foot ulcer and
- patients aged 18 years or older.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | PTA procedure |
Primary outcome
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
5 secondary outcomes
Amputation free survival
Time frame: 2 years
Number of patients with all-cause mortality
Time frame: 2 years
Number of participants with Major adverse events
Time frame: 2 years
Number of patients with 30-day morbidity and mortality
Time frame: 30 days
Number of patients requiring re-intervention
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Ischemic Foot Ulcers
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Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.
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Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia
Peripheral Arterial Disease, Critical Limb-Threatening Ischemia
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Diabetic Foot, Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitrios Tsetis, MD, PhD study chair
University of Crete
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous transluminal angioplasty (PTA) in people with Ischemic Foot Ulcers, run by University of Crete.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with ulcer healing (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.