RESPOND Restoring Equilibrium and Wound Stimulation to Promote Healing Of Non-healing DFUs

Exclusion Criteria

• •Index ulcer wound has exposed tendons, ligaments, muscle, or bone
• •Index ulcer wound presents with clinical signs of acute infection, suspected or known
• •Subjects with evidence of osteomyelitis or cellulitis or gangrene in the study limb
• •Subjects with active Charcot's foot on the study limb
• •Subjects with amputation above a Trans Metatarsal Amputation (TMA) in the affected limb
• •Subjects with active malignancy on the study limb except non-melanoma skin cancer
• •Subjects with planned vascular surgery, angioplasty or thrombolysis procedures within the study period
• •Subjects within 6 weeks post-operatively of a vascular procedure.
• •Subject has had prior skin replacement, negative pressure therapy, or ultrasound therapy applied to the index wound in the 14 days prior to screening
• •Subjects who have received oral, or IV antibiotic/antimicrobial agents or medications have been used within 2 days (48 hours) of baseline.
• •Subjects who have received topical antibiotic/antimicrobial agents or dressings at the index wound site within 2 days (48 hours) of baseline.
• •Subjects currently taking steroids of \>10mg dosage
• •Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within 14 days of screening date.
• •Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
• •Subject has one or more medical condition(s), uncontrolled diabetes (HbA1c \> 12), renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the investigator would make the subject an inappropriate study candidate
• •Subject allergic to a broad spectrum of primary \& secondary dressing materials, including occlusive dressings and the adhesives on such dressings.
• •Female subjects that are pregnant or refuse to utilize adequate contraceptive methods and are of childbearing age during the trial.
• •Subject is known to be suffering from a disorder or other situation that the subject or investigator feels would interfere with compliance or other study requirements
• •Subject is currently enrolled or has been enrolled in the last 30 days in another investigational device or drug trial