MIRODERM H2H DFU Study

Diabetic Foot Ulcer Clinical Trial

— H2H-DFU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03232333
• Other study ID #: 2016002
• Status: Completed
• Start date: July 21, 2017
• Est. completion date: September 20, 2018

Study information

• Verified date: October 2019
• Source: Miromatrix Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 20, 2018
• Est. primary completion date: September 20, 2018
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer

Intervention

Device:
• Biologic wound graft
Diabetic foot ulcer will be treated by grafting with MIRODERM Biologic Wound Matrix

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Miromatrix Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MIRODERM Applications	Frequency of MIRODERM applications prior to wound closing	12 weeks
Other	Time to Closure	Measures the time from treatment to wound healing	12 weeks
Other	Change in Patient's Wound Size	Gives the mean area that the wound closed per week	12 weeks
Other	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)
Other	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)
Other	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)
Primary	Percentage of Participants	Percentage of participants with healed ulcers within 12 weeks of treatment	12 weeks