MIRODERM H2H DFU Study

NCT03232333 | Completed Results FDA Device

• 1 other identifier: 2016002
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants

  Percentage of participants with healed ulcers within 12 weeks of treatment

  12 weeks

Other Outcomes (6)

• MIRODERM Applications

  12 weeks

• Time to Closure

  12 weeks

• Change in Patient's Wound Size

  12 weeks

Study Arms (1)

MIRODERM

Biologic wound graft

Device: Biologic wound graft

Interventions

Biologic wound graft DEVICE

Diabetic foot ulcer will be treated by grafting with MIRODERM Biologic Wound Matrix

Also known as: MIRODERM Biologic Wound Matrix treatment

MIRODERM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who have at least one small to moderately sized diabetic foot ulcer and have been undergoing extended and unsuccessful treatment, as defined by failure of the wound to completely close over the previous 3 months and after application of at least 2 biological products.

You may qualify if:

• 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

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

Sponsors & Collaborators

• Miromatrix Medical Inc.: lead

Study Sites (9)

ILD Research

Carlsbad, California, 92009, United States

Location

Bond Clinic / Clinical Reseach of Central Florida

Winter Haven, Florida, 33880, United States

Location

American Health Network

Avon, Indiana, 46123, United States

Location

Kansas City Institute of Podiatry

Overland Park, Kansas, 66125, United States

Location

St. Anthony's Wound Care Center

St Louis, Missouri, 63128, United States

Location

A Step Ahead Foot Care

Mount Vernon, New York, 10550, United States

Location

Gramercy Park Podiatry

New York, New York, 10010, United States

Location

Foot Associates of New York

New York, New York, 10022, United States

Location

Foot and Ankle Institute

St. George, Utah, 84770, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Debridement waste

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Limitations and Caveats

Not a randomized trial

Results Point of Contact

• Title: Head of Clinical Affairs
• Organization: Miromatrix

mmacenski@miromatrix.com

952.942-6000

Study Officials

• Robert Fridman, DPM

  Foot Associates of New York

  PRINCIPAL INVESTIGATOR

• M Mason Macenski, PhD

  Miromatrix

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: July 28, 2017
• Study Start: July 21, 2017
• Primary Completion: September 20, 2018
• Study Completion: September 20, 2018
• Last Updated: October 22, 2019
• Results First Posted: October 9, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)