Ischemic Foot Ulcers: Is Intervention Better Than Wound Care Alone

NCT00731835 | Terminated DMC

• 1 other identifier: Protocol #2, Version 1
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ischemic Foot Ulcer

Keywords

Vascular

Outcome Measures

Primary Outcomes (1)

• Primary endpoint: wound healing at 4 weeks and 12 weeks

  4 weeks and 12 weeks

Secondary Outcomes (1)

• Secondary endpoints: amputation free survival, time to healing, quality of life, major adverse events.

  2 years

Study Arms (2)

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

Procedure: Endovascular Revascularization

Interventions

Endovascular Revascularization PROCEDURE

* angioplasty, also called percutaneous transluminal angioplasty (PTA) and/or * stent placement * atherectomy

Group 2

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Society for Vascular Surgery: collaborator

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15232, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 11, 2008
• Study Start: July 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 11, 2016

Record last verified: 2016-03

Locations

US (1)