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Phase 1
21 Years
Not Enrolling
Critical Limb Ischemia, Ischemia, Leg Ulcer

Thank you

Trial Information

Inclusion Criteria:

- Be at least 21 years old

- Have critical limb ischemia

- Have severe blockages in at least one artery in the affected leg as demonstrated by
an angiogram

- Have nonhealing leg ulcers and/ or have severe rest pain secondary to a severely
decreased blood flow

- Agree to participate in follow-up.

Exclusion Criteria:

- Have any evidence of malignant neoplasms (other than non-melanoma skin cancer or in
situ carcinoma) within the last 5 years

- Be pregnant or lactating

- Have a history of alcohol or drug abuse within 3 months of screening

- Have advanced (Rutherford Category 6) critical limb ischemia, characterized by
extensive tissue loss or gangrene

- Have osteomyelitis

- Have undergone successful aortic or lower extremity surgery, angioplasty, or lumbar
sympathectomy within the 2 months preceding screening

- Be a suitable candidate for surgical or endovascular revascularization in the limb in
which treatment is proposed

- Subjects in whom arterial insufficiency in the lower extremity is the result of a
non-atherosclerotic disorder

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind

Principal Investigator

Douglas W. Losordo, MD

Investigator Role:

Study Director

Investigator Affiliation:

Northwestern University


United States: Food and Drug Administration

Study ID:

BB-IND 11948



Start Date:

Completion Date:

April 2008

Related Keywords:

  • Critical Limb Ischemia
  • Ischemia
  • Leg Ulcer
  • Nonhealing leg ulcers
  • Ischemic rest pain
  • Ischemia
  • Leg Ulcer
  • Ulcer



Caritas St. Elizabeth's Medical CenterBrighton, Massachusetts  02135-2997
Cardiology PCBirmingham, Alabama  35211
The Minneapolis Heart Institute at Abbott Northwestern HospitalMinneapolis, Minnesota  55407