MIRODERM H2H DFU Study

Completed

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

Detailed Description: The primary objective of this study is to determine the number of successful complete wound closures within 12 weeks of treatment with MIRODERM Fenestrated Biological Wound Matrix. Some secondary objectives of this study include documenting the time course of wound healing and assessing changes in quality of life.

The primary cohort is individuals suffering from a diabetic foot ulcer that has not been healed in the last 3 months and after at least 2 attempts with an advanced biologic. Ulcer will be between 1 and 12 cm squared, less than 5 mm deep, full thickness, below the ankle, and with no exposed bone or tendon. Subjects will be 18 or older, have Type I or II diabetes with adequate vascular profusion. Subjects will be unable to participate if they have osteomyelitis, Charcot foot, a known collagen vascular disease, are on dialyses, are immunocompromised or have an HbA1c level equal to or great than 12%.

This is a single-arm study with no Independent Variables. Descriptive data to be collected will include demographics, pathology and medical history.

Outcome assessments:

* proportion of subjects with 100% epithelialization of wound

* SF-36

* Adverse events

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
MIRODERM	Biologic wound graft	Biologic wound graft

Primary Outcome Measures

Name	Time	Method
Percentage of Participants	12 weeks	Percentage of participants with healed ulcers within 12 weeks of treatment

Secondary Outcome Measures

Name	Time	Method

Locations (9): Foot and Ankle Institute
🇺🇸
Saint George, Utah, United States
Foot Associates of New York
🇺🇸
New York, New York, United States
ILD Research
🇺🇸
Carlsbad, California, United States
St. Anthony's Wound Care Center
🇺🇸
Saint Louis, Missouri, United States
Bond Clinic / Clinical Reseach of Central Florida
🇺🇸
Winter Haven, Florida, United States
Kansas City Institute of Podiatry
🇺🇸
Overland Park, Kansas, United States
Gramercy Park Podiatry
🇺🇸
New York, New York, United States
American Health Network
🇺🇸
Avon, Indiana, United States
A Step Ahead Foot Care
🇺🇸
Mount Vernon, New York, United States