Ischemic Foot Ulcers: Is Intervention Better Than Wound Care Alone

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Society for Vascular Surgery
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00731835
First received: August 6, 2008
Last updated: August 8, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention
Ischemic Foot Ulcer
Procedure: Endovascular Revascularization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ischemic Foot Ulcers: Is Intervention Better Than Wound Care Alone? A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Primary endpoint: wound healing at 4 weeks and 12 weeks [ Time Frame: 4 weeks and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary endpoints: amputation free survival, time to healing, quality of life, major adverse events. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: July 2008
Arms Assigned Interventions
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

Procedure: Endovascular Revascularization
  • angioplasty, also called percutaneous transluminal angioplasty (PTA) and/or
  • stent placement
  • atherectomy

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:

  1. Wound Care (group 1)--Best standard wound care with aggressive debridement
  2. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731835

Contacts
Contact: Judi Brimmeier, BSN 412-235-1304 brimmeierj@upmc.edu
Contact: Suzanne David, BSN, MPH 412-623-8443 davids@upmc.edu

Locations
United States, Pennsylvania
UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Judi Brimmeier, BSN    412-235-1304    brimmeierj@upmc.edu   
Principal Investigator: Rabih Chaer, MD         
Sponsors and Collaborators
University of Pittsburgh
Society for Vascular Surgery
  More Information

No publications provided

Responsible Party: Rabih Chaer, MD, Assistant Professor of Surgery, University of Pittsburgh Medical Center
ClinicalTrials.gov Identifier: NCT00731835     History of Changes
Other Study ID Numbers: Protocol #2, Version 1
Study First Received: August 6, 2008
Last Updated: August 8, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Vascular

Additional relevant MeSH terms:
Ischemia
Ulcer
Foot Ulcer
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer

ClinicalTrials.gov processed this record on August 27, 2014