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

Inclusion Criteria: Patients * who are 18 years old or older; * who are diagnosed as having insulin-dependent or non-insulin-dependent diabetes mellitus (5.5% \<HgBA1C\<12%); * who have foot ulcers extending through the epidermis and dermis but not with exposed tendon or bone; * who have a diagnosis of chronic diabetic ulcer; * who have a viable wound bed with granulation tissue as determined by bleeding following debridement; * who have an ulcer size which is at least 1 cm2 and no greater then 16cm2; * who have signed an informed consent form. * who have a wound that has been present for at least 4 weeks at the time of screening. Exclusion Criteria: Patients * 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.