MIRODERM H2H DFU Study

Inclusion Criteria

• 18 years old or older at time of initial visit
• Have Type I or Type II diabetes
• Have a neuropathic diabetic foot ulcer with the following characteristics:
• Is greater than 1 cm2 and less than or equal to 12 cm2
• Has failed to close following at least 2 treatments with a biologic
• Has been present for 90 days or longer
• Does not show signs of infection
• Is full thickness (Wagner Grade I or II)
• Located distal to the malleolus
• Depth of less than or equal to 5 mm
• No exposed capsule, tendon or bone
• No tunneling, undermining or sinus tracts
• Not between the toes
• Be willing and able to maintain required off-loading of affected limb
• Be willing and able to perform necessary dressing changes
• Have at least one of the following:
• An Ankle-brachial index (ABI) ≥ 0.8
• TcPO2 of ≥ 30 mmHg
• A toe pressure of ≥ 50 mmHg

Exclusion Criteria

• Be pregnant or be planning to become pregnant during the study
• Have had a Chopart's Amputation (or higher)
• Have a history of bone cancer of the affected limb
• Be undergoing dialysis
• Have active osteomyelitis or be receiving treatment for osteomyelitis
• Be diagnosed with unstable Charcot Foot on the affected side
• Have an HbA1c level of ≥ 12% within the past 90 days
• Have another ulcer within 2 cm of the study ulcer
• Be immunocompromised or at risk of immunosuppression as determined by the treating investigator
• Have a known collagen vascular disease or connective tissue disease
• Have received treatment of the study ulcer with a skin substitute product or topical growth factor within the past 4 weeks
• Be participating in another medical research study
• Have a sensitivity to porcine material