MIRODERM H2H DFU Study (H2H-DFU)

Effectiveness of MIRODERM® Biologic Wound Matrix in the Treatment of Hard-to-Heal Diabetic Foot Ulcers

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

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: Biologic wound graft

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

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• United States
  • California
    • Carlsbad, California, United States, 92009
      • ILD Research
  • Florida
    • Winter Haven, Florida, United States, 33880
      • Bond Clinic / Clinical Reseach of Central Florida
  • Indiana
    • Avon, Indiana, United States, 46123
      • American Health Network
  • Kansas
    • Overland Park, Kansas, United States, 66125
      • Kansas City Institute of Podiatry
  • Missouri
    • Saint Louis, Missouri, United States, 63128
      • St. Anthony's Wound Care Center
  • New York
    • Mount Vernon, New York, United States, 10550
      • A Step Ahead Foot Care
    • New York, New York, United States, 10010
      • Gramercy Park Podiatry
    • New York, New York, United States, 10022
      • Foot Associates of New York
  • Utah
    • Saint George, Utah, United States, 84770
      • Foot and Ankle Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MIRODERM; Biologic wound graft	Device: Biologic wound graft; Diabetic foot ulcer will be treated by grafting with MIRODERM Biologic Wound Matrix; Other Names: MIRODERM Biologic Wound Matrix treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants	Percentage of participants with healed ulcers within 12 weeks of treatment	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MIRODERM Applications	Frequency of MIRODERM applications prior to wound closing	12 weeks
Time to Closure	Measures the time from treatment to wound healing	12 weeks
Change in Patient's Wound Size	Gives the mean area that the wound closed per week	12 weeks
Short Form F36 - Physical Component Summary Score	Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Physical Function, Role Physical, Bodily Pain, and General health which assess aspects of physical health. These are used to make an overall physical health score, the Physical Component Summary score (PCS). The higher the score the better the subject's physical health. Range from 0-100.	Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)
Short Form 36 - Mental Component Summary Score	Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Vitality, Role Emotional, Social Functioning, and Mental health which assess aspects of Mental health. These are used to make an overall mental health score, the Mental Component Summary score (MCS). The higher the score the better the subject's mental health. Range from 0-100.	Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)
Short Form - 36: Bodily Pain	Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Bodily Pain which assess aspects of physical pain. The higher the score the better the subject's physical health with respect to feeling pain. Range from 0-100.	Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)

Collaborators and Investigators

• Sponsor: Miromatrix Medical Inc.
• Investigators: Principal Investigator: Robert Fridman, DPM, Foot Associates of New York; Study Director: M Mason Macenski, PhD, Miromatrix

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 21, 2017
• Primary Completion (ACTUAL): September 20, 2018
• Study Completion (ACTUAL): September 20, 2018

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (ACTUAL): July 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: 2016002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No