Clinical trial NCT03232333: MIRODERM H2H DFU Study
Official title: Effectiveness of MIRODERM® Biologic Wound Matrix in the Treatment of Hard-to-Heal Diabetic Foot Ulcers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot Ulcer
Lead sponsor: Miromatrix Medical Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-28
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
measure: MIRODERM Applications
timeFrame: 12 weeks
measure: Time to Closure
timeFrame: 12 weeks
measure: Change in Patient's Wound Size
timeFrame: 12 weeks
measure: Short Form F36 - Physical Component Summary Score
timeFrame: Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)
measure: Short Form 36 - Mental Component Summary Score
timeFrame: Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)
measure: Short Form - 36: Bodily Pain
timeFrame: Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)
Locations:
city: Carlsbad
country: United States
facility: ILD Research
state: California
city: Winter Haven
country: United States
facility: Bond Clinic / Clinical Reseach of Central Florida
state: Florida
city: Avon
country: United States
facility: American Health Network
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Institute of Podiatry
state: Kansas
city: Saint Louis
country: United States
facility: St. Anthony's Wound Care Center
state: Missouri
city: Mount Vernon
country: United States
facility: A Step Ahead Foot Care
state: New York
city: New York
country: United States
facility: Gramercy Park Podiatry
state: New York
city: New York
country: United States
facility: Foot Associates of New York
state: New York
city: Saint George
country: United States
facility: Foot and Ankle Institute
state: Utah
Study officials:
affiliation: Foot Associates of New York
name: Robert Fridman, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: Miromatrix
name: M Mason Macenski, PhD
role: STUDY_DIRECTOR
References: