TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers

Exclusion Criteria

• •having ulcers less than 1cm2 or greater than 16cm2 in size;
• •having severe arterial disease (ankle brachial index (ABI) less than 0.65);
• •having history of radiation therapy to the ulcer site;
• •who use corticosteroids \>10mg prednisone daily
• •who use any immune suppressive, or severely immunocompromised patients;
• •who have an ulcer that was of a non-diabetic pathophysiology;
• •having vasculitis, severe rheumatoid arthritis, or other collagen vascular disease;
• •having malnutrition (defined by albumin \<2.5 g/dL);
• •having a known allergy or hypersensitivity to the components of either TheraGauze or Regranex;
• •having erythema or purulence associated with a severe infection of the wound site;
• •having signs and symptoms of cellulitis, osteomyelitis, necrotic or avascular ulcer beds;
• •undergoing hemodialysis;
• •having uncontrolled diabetes (defined as HgB A1c\>12%)
• •having deficient blood supply to ulcers (defined as capillary fill time \>3 seconds at tips of toes)
• •having Charcot's neuroarthropathy as determined by clinical and/or radiographic examination;
• •having sickle cell disease;
• •having exposed bone, tendon, or fascia;
• •who are currently enrolled in a clinical evaluation of another investigational device or drug, or have received and investigational treatment for diabetic foot ulcers in the last 30 days;
• •unable to comply with the procedures described in the protocol.