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Status:

COMPLETED

MIRODERM H2H DFU Study

Lead Sponsor:

Miromatrix Medical Inc.

Conditions:

Diabetic Foot Ulcer

Eligibility:

All Genders

18+ years

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 obje...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 21 2017

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 20 2018

Estimated Enrollment :

53 Patients enrolled

Trial Details

Trial ID

NCT03232333

Start Date

July 21 2017

End Date

September 20 2018

Last Update

October 22 2019

Active Locations (9)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (9 locations)

1

ILD Research

Carlsbad, California, United States, 92009

2

Bond Clinic / Clinical Reseach of Central Florida

Winter Haven, Florida, United States, 33880

3

American Health Network

Avon, Indiana, United States, 46123

4

Kansas City Institute of Podiatry

Overland Park, Kansas, United States, 66125