Ischemic Foot UlcerNCT00731835
Ischemic Foot Ulcers: Is Intervention Better Than Wound Care Alone
A study testing Endovascular Revascularization in people with Ischemic Foot Ulcer, run by University of Pittsburgh at 1 site in United States.
Trial summary
You are being asked to take part in this study because your doctor has determined that you have an ischemic foot ulcer. This research study will compare two approved standard of care treatment modalities for the management of ischemic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Ischemic Foot Ulcer
- What is being tested?
- Endovascular Revascularization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Sep 2011
- 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 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject (male or non-pregnant female) must be greater than or equal to 18 years of age
- Ischemic ulcer of foot present
- An ankle-brachial index (ABI) of 0.4 to 0.8 or monophasic-biphasic waveforms on pulse volume recordings. (If the subject is diabetic or has renal failure, with incompressible vessels, a toe brachial index of 0.4 to 0.8 is required.)
- Signed informed consent
Who cannot join
- Severe ischemia as defined by advanced gangrene, an ABI of less then or equal to 0.3 and monophasic waveforms on pulse volume recording
- Advanced renal insufficiency, defined as serum creatinine greater than or equal to 3 mg/dl
- Absolute contraindication to contrast media, as determined by the investigator
- Unwilling or unable to provide informed consent or return for required follow-up evaluations.
- Previous enrollment in this clinical study
- Concurrent participation in another clinical research study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ischemic Foot Ulcers: Is Intervention Better Than Wound Care Alone? A Randomized Controlled Trial
You are being asked to take part in this study because your doctor has determined that you have an ischemic foot ulcer. This research study will compare two approved standard of care treatment modalities for the management of ischemic foot ulcers. The ischemic foot ulcer (wound) on your foot is a result of a blocked artery in your leg. The wound can sometimes be healed with wound care alone, which includes dressing changes with creams and removing (debriding) the dead tissue. Alternatively, the significant narrowing or blockage in one of the arteries in your leg can be treated with several endovascular treatment techniques including:
- angioplasty, also called percutaneous transluminal angioplasty (PTA) and/or
- stent placement
- atherectomy
The hypothesis of this study is that early endovascular or surgical intervention in subjects with moderate arterial insufficiency and a non-healing foot ulcer results in a higher overall incidence of wound healing in a significantly shorter period of time.
Read the detailed description
Design:
This study is a single center, prospective, randomized trial evaluating the benefit of endovascular intervention on the healing of ischemic foot ulcers when compared to best wound care alone. The study population will be comprised of subjects with a foot ulcer and non-palpable or diminished pedal pulses. The expected duration of subjects in this trial is 2 years.
Patients will be randomized into two groups:
- Wound Care (group 1)--Best standard wound care with aggressive debridement
- Endovascular Intervention + Wound Care (group 2)--Best standard wound care in combination with endovascular revascularization
Subjects will undergo standard of care evaluation for ischemic foot ulcers. These same evaluations would be performed whether or not the subject was participating in this research study. In the event that a clinically significant event or unanticipated disease or condition is identified, the subject and their doctor will be notified, the investigator, will review the results of the tests and procedures that are standard of care, and the results will become part of the research record. Prior to undergoing randomization, the subject will sign and fully understand an IRB consent form that is HIPAA compliant.
- Conditions
- Ischemic Foot Ulcer
- Being tested
- Endovascular Revascularization
- Keywords
- Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular RevascularizationProcedure or surgery
- angioplasty, also called percutaneous transluminal angioplasty (PTA) and/or
- stent placement
- atherectomy
| Study group | Role | What they receive |
|---|---|---|
| Group I | No intervention | 1. Wound Care (group 1)--Best standard wound care with aggressive debridement |
| Group 2 | Active comparator | 2. Endovascular Intervention + Wound Care (group 2)--Best standard wound care in combination with endovascular revascularization
Endovascular revascularization is the intervention Receives: Procedure: Endovascular Revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint: wound healing at 4 weeks and 12 weeks
Measured: 4 weeks and 12 weeks
Secondary outcomes (1)
Secondary endpoints: amputation free survival, time to healing, quality of life, major adverse events.
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 posted11 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Foot UlcerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Society for Vascular Surgery
- Responsible party
- Principal investigator, Rabih A. Chaer, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731835
- Sponsor's protocol ID
- Protocol #2, Version 1
- Status last verified
- Mar 2016
- First submitted
- 6 Aug 2008
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemic Foot Ulcers: Is Intervention Better Than Wound Care Alone? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00731835
- Acronym / sponsor ID
- Protocol #2, Version 1
- Conditions
- Ischemic Foot Ulcer
- Keywords
- Vascular
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Society for Vascular Surgery
- Study start
- Jul 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 11 Aug 2008 (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.
You are being asked to take part in this study because your doctor has determined that you have an ischemic foot ulcer. This research study will compare two approved standard of care treatment modalities for the management of ischemic foot ulcers. The ischemic foot ulcer (wound) on your foot is a result of a blocked artery in your leg. The wound can sometimes be healed with wound care alone, which includes dressing changes with creams and removing (debriding) the dead tissue. Alternatively, the significant narrowing or blockage in one of the arteries in your leg can be treated with several endovascular treatment techniques including:
- angioplasty, also called percutaneous transluminal angioplasty (PTA) and/or
- stent placement
- atherectomy
The hypothesis of this study is that early endovascular or surgical intervention in subjects with moderate arterial insufficiency and a non-healing foot ulcer results in a higher overall incidence of wound healing in a significantly shorter period of time.
Detailed description
Design:
This study is a single center, prospective, randomized trial evaluating the benefit of endovascular intervention on the healing of ischemic foot ulcers when compared to best wound care alone. The study population will be comprised of subjects with a foot ulcer and non-palpable or diminished pedal pulses. The expected duration of subjects in this trial is 2 years.
Patients will be randomized into two groups:
- Wound Care (group 1)--Best standard wound care with aggressive debridement
- Endovascular Intervention + Wound Care (group 2)--Best standard wound care in combination with endovascular revascularization
Subjects will undergo standard of care evaluation for ischemic foot ulcers. These same evaluations would be performed whether or not the subject was participating in this research study. In the event that a clinically significant event or unanticipated disease or condition is identified, the subject and their doctor will be notified, the investigator, will review the results of the tests and procedures that are standard of care, and the results will become part of the research record. Prior to undergoing randomization, the subject will sign and fully understand an IRB consent form that is HIPAA compliant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | No intervention | –1. Wound Care (group 1)--Best standard wound care with aggressive debridement |
| Group 2 | Active comparator | Procedure: Endovascular Revascularization2. Endovascular Intervention + Wound Care (group 2)--Best standard wound care in combination with endovascular revascularization Endovascular revascularization is the intervention |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The subject (male or non-pregnant female) must be greater than or equal to 18 years of age
- Ischemic ulcer of foot present
- An ankle-brachial index (ABI) of 0.4 to 0.8 or monophasic-biphasic waveforms on pulse volume recordings. (If the subject is diabetic or has renal failure, with incompressible vessels, a toe brachial index of 0.4 to 0.8 is required.)
- Signed informed consent
Key exclusion criteria (6 listed)
- Severe ischemia as defined by advanced gangrene, an ABI of less then or equal to 0.3 and monophasic waveforms on pulse volume recording
- Advanced renal insufficiency, defined as serum creatinine greater than or equal to 3 mg/dl
- Absolute contraindication to contrast media, as determined by the investigator
- Unwilling or unable to provide informed consent or return for required follow-up evaluations.
- Previous enrollment in this clinical study
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 |
|---|---|---|
| Endovascular Revascularization* angioplasty, also called percutaneous transluminal angioplasty (PTA) and/or * stent placement * atherectomy | Procedure or surgery | Group 2 |
Primary outcome
Primary endpoint: wound healing at 4 weeks and 12 weeks
Time frame: 4 weeks and 12 weeks
1 secondary outcome
Secondary endpoints: amputation free survival, time to healing, quality of life, major adverse events.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Revascularization in people with Ischemic Foot Ulcer, run by University of Pittsburgh at 1 site in United States.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 11 Mar 2016. 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 United States. 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.
Are results available for this study?
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
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?
Primary endpoint: wound healing at 4 weeks and 12 weeks (time frame: 4 weeks and 12 weeks). 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 11 Mar 2016.