Beta Adrenergic Antagonist for the Healing of Chronic DFU (BAART-DFU)

This is an interventional treatment trial for Chronic Diabetic Foot Ulcers Read More

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