Peripheral Artery Disease Without Critical Limb IschemiaPhase 2NEWLINCT01666093
Non-Healing Ulcers Without Critical Limb Ischemia
A Phase 2 study testing Angioplasty of the lower limbs vessels in people with Peripheral Artery Disease Without Critical Limb Ischemia, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Background: Lower limb arterial revascularization procedures, either percutaneously or surgically performed, are an established treatment modality of ischemic foot ulcers, especially in the setting of a critical limb ischemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease Without Critical Limb Ischemia
- What is being tested?
- Angioplasty of the lower limbs vessels
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2012to Aug 2015
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients need to be at least 18 years old
- Patients have to be admitted to the university hospitals of Geneva for a non-healing lower limb ulcer.
- Eligible patients are those presenting with non-healing lower limb ulcers for more than 3 months.
- Patients will be hospitalized in the Dermatology inpatient clinic.
- Patients had to benefit from at least one thin skin autograft at the ulcer level in the past or during the index hospitalization.
- Before inclusion in the study, patients must undergo complete angiological diagnostic work-up including:
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- A baseline ABI, toe pressure and tcPO2 measurements,
- A non-invasive arterial imaging including an angio-CT scan or an angio-MRI,
- The non-invasive arterial work-up must revel mild to moderate PAD, without any criteria or sign of CLI (see flow-chart):
- Ankle pressure ≥ 50 mmHg,
- + ABI: < 0.9 or > 1.3,
- ± Toe pressure : 30-100 mmHg
- ± tcPO2: 20-40 mmHg,
- At this moment the patient may be included in the study protocol.
- All patients presenting with mild to moderate PAD and evidence of at least 1 impaired arterial vessel targeting the ulcer will initially undergo conservative impatient clinic care for at least 2-4 weeks and benefit from at least 1 thin skin autograft.
- Persisting surface of lower limb ulcers will be assessed 1 month later:
- -- In the presence of a healed ulcer surface > 70%, the patient will undergo 6 months of clinical follow up at 1-3-6 months.
- 1. In case of persistence of healed ulcer surface > 70% clinical success will be achieved.
- 2. In presence of healed ulcer surface < 70% the patient will undergo a new angiological work-up.
- If mild to moderate PAD will be again outlined the patient will join the < 70% healed ulcer group.
- On the other hand, if CLI will be pointed out lower limb revascularisation and at least one thin skin autograft will be performed.
- -- In presence of a healed ulcer surface < 70%, endovascular PTA and at least one thin skin autograft will be performed. The ulcers healing will then be monitored at 1-3-6 months and persisting ulcers surface re-assessed:
- in presence of an healed ulcer surface > 70% clinical success will be achieved,
- if presence of an healed ulcer surface < 70% clinical failure will be retained.
Who cannot join
- Patients who refused to give their written informed consent.
- Patients, in whom the angiological work-up shows the presence of a CLI, mandating a revascularization procedure attempt (i.e. ankle pressure < 50mmHg, toe pressure < 30mmHg, tcPO2 < 20mmHg) (see particular situation n°2).
- Patients who do not present with peripheral artery disease (i.e., ABI > 0.9 - < 1.3, TP > 100mmHg, tcPO2 > 40mmHg).
- Patients in whom the angiological-dermatological work-up shows the presence of another reversible cause of the non-healing ulcer:
- Special attention will be given to the presence of a treatable venous insufficiency (e.g. compression stocking, varices stripping), an underlying inflammatory/infectious process (treatable with antibiotics or topic-systemic antiinflammatory medications) or other reversible mechanical factors (unadapted shoes, etc.).
- Patients without any significant lesion of the arterial tree (ilio-femoro-popliteal and infra-popliteal):
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- In case there will be a single BTK vessel disease not perfusing the ulcer area (e.g. pre-tibial ulcer with a significant stenosis of the posterior tibial artery which does not perfuse the ulcer region), the patient will not be included in the study because any significant ulcer improvement would be expected from this non-target vessel revascularization.
- Patients in whom the scheduled revascularization procedure will be judged too risky for the patient's safety:
- Chronic kidney failure (= Creatinin Clearance < 20ml/min) with an increased risk of contrast induced nephropathy,
- Too complex arterial disease or anatomy, in which the estimated procedural technical success rate is < 50% (i.e. complex chronic total occlusion).
- Patients in whom an amputation is unavoidable, despite any revascularization attempt (e.g. extensive skin necrosis [Rutherford class 6]), - If, it will be estimated that, a successful revascularization procedure may reduce the level of amputation, or if a successful intervention may improve the amputation's healing process, the patient may be included in the study.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Angiology and Dermatology Divisions / HUG
Geneva, Canton of Geneva, 1211
Robert F Bonvini, MD, 0041 22 372 72 00, robert.bonvini@hcuge.ch
Robert F Bonvini, MD
About this study
Official title: NON-HEALING ULCERS WITHOUT CRITICAL LIMB ISCHEMIA (NEWLI-Trial): A Single Center Pilot Trial on the Efficacy of an Endovascular Approach for Treatment of Non-healing Lower Limb Ulcers in Patients Presenting With a Mild to Moderate Peripheral Artery Disease
Background: Lower limb arterial revascularization procedures, either percutaneously or surgically performed, are an established treatment modality of ischemic foot ulcers, especially in the setting of a critical limb ischemia. Many other lower limb ulcers are secondary to a combined disease, which may include a concomitant venous disease (chronic venous insufficiency or varicous disease) or a micro-angiopathic disease (i.e. small vessel disease). In this setting, and especially in the absence of a concomitant severe macro-angiopathic disease, the safety and efficacy of a percutaneous lower limb revascularization have so far never been evaluated in a prospective study.
Aim: This study is aimed to evaluate the safety and the efficacy of an endovascular revascularization approach of the lower limb, in all consecutive patients presenting with a non-healing ulcer associated with a mild to moderate peripheral artery disease (i.e. mixed-origin ulcers).
Read more
Material and methods: This prospective study will consecutively include all patients presenting with a non-healing ulcer. Included patients must have all the concomitant ulcer co-factors being adequately treated for at least 6 months. Accordingly, an underlying venous disease, infectious disease or inflammatory disorder must be previously evaluated and adequately treated (i.e. compression stocking, varices stripping, antibiotics, local ± systemic anti-inflammatory, etc.). Furthermore, a non-invasive arterial evaluation must be obtained in all patients. The arterial screening must included an ankle-brachial index (ABI) and toe pressure (TP) measurements, a trans-cutaneous oxygen measurement (tcPO2) at the foot and calf levels and a non-invasive arterial mapping (i.e. angio-CT or angio-MRI). This arterial work-up must be compatible with the presence of a mild to moderate peripheral artery disease without any sign or criteria suggesting the presence of a critical limb ischemia.
End-points: The success rate of perform an endovascular revascularization intervention in all consecutive patients which qualify according to the inclusion criteria (technical feasibility). Establish the proportion of procedural related complications (safety). Analyze the clinical and the para-clinical improvements in term of heal of the ulcers, as well as the improvement of the ABI, TP, tcPO2 at 1 week, 1-3-6 months after the procedure (efficacy).
Sample size: The investigators plan to include ≈ 30 patients in two years. After 1 year of enrollment the investigators will perform an interim analysis and will decide at that moment, according to the observed end-points, if prolonging the study would be of any scientific value or if the study has to be interrupt earlier because of a significant improvement of all already treated ulcers.
Read the detailed description
see above
- Being tested
- Angioplasty of the lower limbs vessels
- Keywords
- peripheral artery disease, endovascular procedure, non-healing ulcer
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angioplasty of the lower limbs vesselsProcedure or surgery
Standard revascularization techniques will be used in the study
| Study group | Role | What they receive |
|---|---|---|
| revascularization group | Other | patients will revascularized after a conservative treatment failure of at least 4 weeks Receives: Procedure: Angioplasty of the lower limbs vessels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer healing
- Procedural efficacy: efficacy will be evaluated according to clinical and para-clinical parameters:
- Clinical efficacy: i. ulcer heal or improvement at 6 months; ii. avoidance of minor (i.e. toe or for-foot) or major (i.e. below or above the knee) amputations; iii. improvement of the ulcer-related pain:
- The ulcer-related pain will be evaluated with the use of the Borg visual assist scale (Borg VAS) before, at 1 week, 1-3-6 months after the procedure. iv. Improvement of the ulcer size:
- The ulcer size will be recorded by measurements and photographic records before, at 1 week, 1-3-6 months after the procedure.
- The number of skin grafts necessary to heal the ulcer will be recorded and compared to the number of the skin grafts which have failed to heal the ulcer in the pre-revascularization period.
Measured: at 6 months
Secondary outcomes (2)
Efficacy
- Para-clinical efficacy: improvement of the ABI, TP, tcPO2 values at 1 week, 1-3-6 months after the procedure.
- Procedural success, defined as a successful endovascular revascularization procedure, in all consecutive patients according to the inclusion and exclusion criteria = technical feasibility.
Measured: 6 months
Safety
- Procedural safety, defined as the proportion of procedures performed in the absence of any procedural-related complications (= safety).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2014 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery Disease Without Critical Limb IschemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert F Bonvini, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666093
- Sponsor's protocol ID
- NEWLI-Trial
- Other IDs
- NAC 12-025
- Acronym
- NEWLI
- Status last verified
- Aug 2012
- First submitted
- 9 Aug 2012
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NON-HEALING ULCERS WITHOUT CRITICAL LIMB ISCHEMIA (NEWLI-Trial): A Single Center Pilot Trial on the Efficacy of an Endovascular Approach for Treatment of Non-healing Lower Limb Ulcers in Patients Presenting With a Mild to Moderate Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT01666093
- Acronym / sponsor ID
- NEWLI / NEWLI-Trial
- Keywords
- peripheral artery disease, endovascular procedure, non-healing ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 16 Aug 2012 (estimated)
- 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.
Background: Lower limb arterial revascularization procedures, either percutaneously or surgically performed, are an established treatment modality of ischemic foot ulcers, especially in the setting of a critical limb ischemia. Many other lower limb ulcers are secondary to a combined disease, which may include a concomitant venous disease (chronic venous insufficiency or varicous disease) or a micro-angiopathic disease (i.e. small vessel disease). In this setting, and especially in the absence of a concomitant severe macro-angiopathic disease, the safety and efficacy of a percutaneous lower limb revascularization have so far never been evaluated in a prospective study.
Aim: This study is aimed to evaluate the safety and the efficacy of an endovascular revascularization approach of the lower limb, in all consecutive patients presenting with a non-healing ulcer associated with a mild to moderate peripheral artery disease (i.e. mixed-origin ulcers).
Material and methods: This prospective study will consecutively include all patients presenting with a non-healing ulcer. Included patients must have all the concomitant ulcer co-factors being adequately treated for at least 6 months. Accordingly, an underlying venous disease, infectious disease or inflammatory disorder must be previously evaluated and adequately treated (i.e. compression stocking, varices stripping, antibiotics, local ± systemic anti-inflammatory, etc.). Furthermore, a non-invasive arterial evaluation must be obtained in all patients. The arterial screening must included an ankle-brachial index (ABI) and toe pressure (TP) measurements, a trans-cutaneous oxygen measurement (tcPO2) at the foot and calf levels and a non-invasive arterial mapping (i.e. angio-CT or angio-MRI). This arterial work-up must be compatible with the presence of a mild to moderate peripheral artery disease without any sign or criteria suggesting the presence of a critical limb ischemia.
End-points: The success rate of perform an endovascular revascularization intervention in all consecutive patients which qualify according to the inclusion criteria (technical feasibility). Establish the proportion of procedural related complications (safety). Analyze the clinical and the para-clinical improvements in term of heal of the ulcers, as well as the improvement of the ABI, TP, tcPO2 at 1 week, 1-3-6 months after the procedure (efficacy).
Sample size: The investigators plan to include ≈ 30 patients in two years. After 1 year of enrollment the investigators will perform an interim analysis and will decide at that moment, according to the observed end-points, if prolonging the study would be of any scientific value or if the study has to be interrupt earlier because of a significant improvement of all already treated ulcers.
Detailed description
see above
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| revascularization group | Other | Procedure: Angioplasty of the lower limbs vesselspatients will revascularized after a conservative treatment failure of at least 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Patients need to be at least 18 years old
- Patients have to be admitted to the university hospitals of Geneva for a non-healing lower limb ulcer.
- Before inclusion in the study, patients must undergo complete angiological diagnostic work-up including:
- The non-invasive arterial work-up must revel mild to moderate PAD, without any criteria or sign of CLI (see flow-chart):
- All patients presenting with mild to moderate PAD and evidence of at least 1 impaired arterial vessel targeting the ulcer will initially undergo conservative impatient clinic care for at least 2-4 weeks and benefit from at least 1 thin skin autograft.
Key exclusion criteria (11 listed)
- Patients who refused to give their written informed consent.
- Patients, in whom the angiological work-up shows the presence of a CLI, mandating a revascularization procedure attempt (i.e. ankle pressure < 50mmHg, toe pressure < 30mmHg, tcPO2 < 20mmHg) (see particular situation n°2).
- Patients who do not present with peripheral artery disease (i.e., ABI > 0.9 - < 1.3, TP > 100mmHg, tcPO2 > 40mmHg).
- Patients in whom the angiological-dermatological work-up shows the presence of another reversible cause of the non-healing ulcer:
- Patients without any significant lesion of the arterial tree (ilio-femoro-popliteal and infra-popliteal):
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 |
|---|---|---|
| Angioplasty of the lower limbs vesselsStandard revascularization techniques will be used in the study | Procedure or surgery | revascularization group |
Primary outcome
Ulcer healing
Time frame: at 6 months
1) Procedural efficacy: efficacy will be evaluated according to clinical and para-clinical parameters: a. Clinical efficacy: i. ulcer heal or improvement at 6 months; ii. avoidance of minor (i.e. toe or for-foot) or major (i.e. below or above the knee) amputations; iii. improvement of the ulcer-related pain: 1. The ulcer-related pain will be evaluated with the use of the Borg visual assist scale (Borg VAS) before, at 1 week, 1-3-6 months after the procedure. iv. Improvement of the ulcer size: 1. The ulcer size will be recorded by measurements and photographic records before, at 1 week, 1-3-6 months after the procedure. v. The number of skin grafts necessary to heal the ulcer will be recorded and compared to the number of the skin grafts which have failed to heal the ulcer in the pre-revascularization period.
2 secondary outcomes
Efficacy
Time frame: 6 months
Safety
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Angioplasty of the lower limbs vessels in people with Peripheral Artery Disease Without Critical Limb Ischemia, run by University Hospital, Geneva at 1 site in Switzerland.
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 24 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 16 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert F Bonvini, MD (0041 22 372 72 00, robert.bonvini@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer healing (time frame: at 6 months). 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 16 Aug 2012.