- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00731835
Ischemic Foot Ulcers: Is Intervention Better Than Wound Care Alone
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15232
- UPMC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Group I
1. Wound Care (group 1)--Best standard wound care with aggressive debridement
|
|
Active Comparator: Group 2
2. Endovascular Intervention + Wound Care (group 2)--Best standard wound care in combination with endovascular revascularization Endovascular revascularization is the intervention |
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Primary endpoint: wound healing at 4 weeks and 12 weeks
Time Frame: 4 weeks and 12 weeks
|
4 weeks and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary endpoints: amputation free survival, time to healing, quality of life, major adverse events.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Protocol #2, Version 1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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Clinical Trials on Endovascular Revascularization
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HealthCore-NERIMassachusetts General Hospital; National Heart, Lung, and Blood Institute (NHLBI) and other collaboratorsCompletedCritical Limb IschemiaUnited States, Canada, New Zealand, Finland, Italy
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Gregory W AlbersMedical University of South Carolina; National Institute of Neurological Disorders... and other collaboratorsTerminatedCerebral Infarction | Stroke, AcuteUnited States
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