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

This is an interventional treatment trial for Diabetic Foot Ulcer Read More

Inclusion Criteria:

• Male or female subject of any race and at least 18 to 90 years old
• Lower extremity full thickness diabetic foot ulcer of 30-364 days duration
• Subject's wound must be between 2cm² and 20cm² at screening
• Subject's wound must be at or below the malleolus
• Documented ABI is between 0.8 and 1.2 on the study limb or transcutaneous partial pressure oxygen (TcpO2) > 40 mmHG; or a toe pressure > 40 mmHG; or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms) within 30 days of screening.
• Subject or subject's legally authorized representative understands the nature of the procedure(s) and provides written informed consent prior to study enrollment
• Subject is willing and able to comply with all specified care and visit requirements
• Subject and/or caregiver must be willing and able to learn and perform the duties of dressing changes, and demonstrate the ability to do so.

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