Prospective, Multicenter, RCT of the Tenex Ultrasound System

Exclusion criteria

• . Index ulcer and/or index limb with presence of gangrene or unstable ischemia at screening and baseline/treatment initiation visit. Note: Baseline/treatment initiation visit should be no more than 10 days after screening. If baseline/treatment initiation visit \>10 days after screen, rescreen patient.
• . Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \> 10mg prednisone (or equivalent daily dose), cytotoxic chemotherapy, or who are anticipated to require such medications during the study.
• . Index ulcer treated within the last 30 days prior to screening with a prohibited treatment or throughout the trial:
• . Active Charcot's arthropathy of the index ulcer limb as verified by clinical evaluation, and/or imaging (x-ray or MRI) within 30 days prior to screening.
• . Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment including offloading.
• . Subjects with osteomyelitis on the same limb as the index ulcer as verified by clinical evaluation, and/or imaging (x-ray or MRI) within 30 days prior to screening. Note that with Wagner 1 DFUs, an Xray or MRI would be required for diagnosis of osteomyelitis. For Wagner 2 DFUs, an MRI would be required for diagnosis of osteomyelitis.
• . Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 60 days of screening.
• . Subjects with end stage renal disease on hemodialysis.