MIRODERM H2H DFU Study

Completed

Conditions studied: Diabetic Foot Ulcer

In brief

This study will assess the ability of MIRODERM to heal difficult diabetic foot ulcers within 12 weeks of treatment.

Key facts

Study ID

NCT03232333

Run by

Miromatrix Medical Inc.

People needed

53

Starts

2017-07-21

Expected to finish

2018-09-20

Last updated by the study team

2019-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ILD Research — Carlsbad, California, United States
• Bond Clinic / Clinical Reseach of Central Florida — Winter Haven, Florida, United States
• American Health Network — Avon, Indiana, United States
• Kansas City Institute of Podiatry — Overland Park, Kansas, United States
• St. Anthony's Wound Care Center — St Louis, Missouri, United States
• A Step Ahead Foot Care — Mount Vernon, New York, United States
• Gramercy Park Podiatry — New York, New York, United States
• Foot Associates of New York — New York, New York, United States
• Foot and Ankle Institute — St. George, Utah, United States

Full record on ClinicalTrials.gov

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