| Eligibility |
Inclusion Criteria:
- Male or female subject of any race 18 years old or older
- Lower extremity ulcer located anywhere on the foot (as defined as beginning below the
malleoli of the ankle):
- Of more than 30 days duration and less than 2 years duration
- Surface area between 0.5cm2 and 20cm2 (as measured with the Silhouette imaging
system at randomization). The ulcer with largest surface area meeting inclusion
criteria will be selected as index ulcer
- If two ulcers present with the same surface area, the ulcer of the longest
duration will be selected as index ulcer
- Documented Ankle Brachial Index (ABI) between 0.8 and 1.2 on the study limb or toe
pressure over 65mmHg within 3 months of screening phase
- Documented biopsy report to rule out malignancy of ulcer of > 6 months duration
- Subject or legally authorized representative understands and is willing to give
written informed consent
- Subject or legally authorized representative is willing and able to comply with a
trial (13 to 17 days) of protocol-specified standard care prior to randomization and
to comply with all study requirements
Exclusion Criteria:
- Ulcer of non-diabetic etiology, such as venous, arterial and burn wounds
- Index ulcer is less than 3 cm in distance from any other ulcer on the same extremity
- There are greater than 3 ulcers on the study foot
- Index ulcer presents with any of the following: cellulitis, osteomyelitis, exposed
bone, tendon or fascia, capsule , purulent exudate or gangrene
- Index ulcer shows evidence of infection (defined as a moderate or severe rating of all
of the following clinical signs/symptoms:
- increased warmth
- increased pain
- erythema
- malodorous exudate at Screening or at Randomization (Visit 1), OR total organism
count > 1 x 105 colony forming units (CFU) from the screening visit study ulcer
culture sample)
- Index ulcer surface area has decreased or increased > 40% between Screening and at
Randomization (Visit 1) as assessed by the Silhouette imaging system
- Has acquired or is known to be infected with Human Immunodeficiency Virus (HIV)
- Has active malignancy on the study foot
- Has uncontrolled diabetes mellitus as defined by glycosylated hemoglobin A1C > 12%
- Has immunodeficiency as defined by serum IgG, IgA, and IgM less than one-half the
lower limit of normal
- Has severe protein malnutrition as defined by serum albumin < 2.5 g/dL
- Has serum aspartate aminotransferase (AST, SGOT, GOT) or serum alanine
aminotransferase (ALT, SGPT, GPT) levels greater than twice the upper limit of normal
- Has fatigue, palpitations, dyspnea, and/or angina at rest
- Has a history, within the previous 12 months from date of Screening Visit, of alcohol
or drug abuse, particularly methadone or heroin
- Has received previous treatment with the following during the 60 days prior to
Screening:
- Immunosuppressive agents
- radiation
- chemotherapy
- growth factors (epidermal growth factor, tumor necrosis factor, transforming
growth factor, platelet derived growth factor, etc.)
- at the site of the study ulcer, split- or full-thickness skin graft at the
site of the study ulcer, biologically-active (or engineered) cellular or
acellular product(s) at the site of the study ulcer, investigational drug or
device
- Has been hospitalized for treatment of a diabetic foot ulcer within the previous 30
days from Screening
- Has history of heart block 2nd and 3rd degree
- Female who is pregnant or refuses to use adequate contraceptive methods and is of
childbearing age during the trial
- Prisoners, institutionalized individuals or vulnerable population
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