Trial Outcomes & Findings for MIRODERM H2H DFU Study (NCT NCT03232333)

NCT ID: NCT03232333

Last Updated: 2019-10-22

Results Overview

Percentage of participants with healed ulcers within 12 weeks of treatment

• Recruitment status: COMPLETED
• Target enrollment: 53 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2019-10-22

Participant Flow

Participant milestones

Measure	MIRODERM Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix
Overall Study STARTED	53
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Measure	MIRODERM Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix
Overall Study Infection or Osteomyelitis	9
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	2

Baseline Characteristics

8 are hispanic

Baseline characteristics by cohort

Measure	MIRODERM n=38 Participants Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix
Wound Location Forefoot	14 Participants n=38 Participants
Wound Location Midfoot	14 Participants n=38 Participants
Wound Location Heel	7 Participants n=38 Participants
Age, Continuous	61.7 years STANDARD_DEVIATION 9.2 • n=38 Participants
Sex: Female, Male Female	28 Participants n=38 Participants
Sex: Female, Male Male	10 Participants n=38 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=38 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=38 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=38 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants • 8 are hispanic
Race (NIH/OMB) Asian	1 Participants n=30 Participants • 8 are hispanic
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=30 Participants • 8 are hispanic
Race (NIH/OMB) Black or African American	5 Participants n=30 Participants • 8 are hispanic
Race (NIH/OMB) White	21 Participants n=30 Participants • 8 are hispanic
Race (NIH/OMB) More than one race	0 Participants n=30 Participants • 8 are hispanic
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=30 Participants • 8 are hispanic
Region of Enrollment United States	38 participants n=38 Participants
BMI	31.2 kg/m^2 STANDARD_DEVIATION 6.3 • n=38 Participants
HbA1c	7.8 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.5 • n=38 Participants
Ankle Brachial Index	1.02 Ratio STANDARD_DEVIATION 0.2 • n=38 Participants
Tobacco Use None	34 Participants n=38 Participants
Tobacco Use < 1 pack/day	3 Participants n=38 Participants
Tobacco Use > 1 pack/day	1 Participants n=38 Participants
Alcohol Use None	28 Participants n=38 Participants
Alcohol Use Occasional	5 Participants n=38 Participants
Alcohol Use Monthly	3 Participants n=38 Participants
Alcohol Use Weekly	1 Participants n=38 Participants
Alcohol Use Daily	1 Participants n=38 Participants
Wound Size Screening	3.5 cm^2 STANDARD_DEVIATION 3.5 • n=38 Participants
Wound Size Treatment	3.5 cm^2 STANDARD_DEVIATION 3.8 • n=38 Participants
Wound Age	41.1 weeks STANDARD_DEVIATION 27.2 • n=38 Participants
Prior Treatments	2 Applications n=38 Participants
Wound Location Toes	3 Participants n=38 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Per protocol analysis

Percentage of participants with healed ulcers within 12 weeks of treatment

Outcome measures

Measure	MIRODERM n=38 Participants Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix
Percentage of Participants	57.89 Percentage of participants with healed u

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: Per protocol analysis

Frequency of MIRODERM applications prior to wound closing

Outcome measures

Measure	MIRODERM n=38 Participants Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix
MIRODERM Applications	2.0 Applications Interval 1.0 to 10.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: Subjects who healed in 12 weeks or less

Measures the time from treatment to wound healing

Outcome measures

Measure	MIRODERM n=22 Participants Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix
Time to Closure	8.1 Weeks Interval 2.0 to 12.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: Per protocol analysis

Gives the mean area that the wound closed per week

Outcome measures

Measure	MIRODERM n=38 Participants Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix
Change in Patient's Wound Size	0.30 cm^2 per week Standard Deviation 0.28

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)

Population: Subjects who's ulcer healed in 12 weeks or less two without appropriate data

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.

Outcome measures

Measure	MIRODERM n=20 Participants Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix
Short Form F36 - Physical Component Summary Score Pre-procedure	39.0 score on a scale Standard Deviation 16.7
Short Form F36 - Physical Component Summary Score Follow-up	37.0 score on a scale Standard Deviation 25.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)

Population: Subjects who's wound healed in 12 weeks or less one without appropriate data

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.

Outcome measures

Measure	MIRODERM n=21 Participants Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix
Short Form 36 - Mental Component Summary Score Pre-procedure	71.0 score on a scale Standard Deviation 16.9
Short Form 36 - Mental Component Summary Score Follow-up	71.9 score on a scale Standard Deviation 13.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)

Population: Per protocol analysis

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.

Outcome measures

Measure	MIRODERM n=21 Participants Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix
Short Form - 36: Bodily Pain Pre-procedure	57.5 score on a scale Standard Deviation 32.2
Short Form - 36: Bodily Pain Follow-up	61.9 score on a scale Standard Deviation 29.0

Adverse Events

MIRODERM

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	MIRODERM n=53 participants at risk Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix
Metabolism and nutrition disorders Diabetic Ketoacidosis	1.9% 1/53 • Number of events 2 • 12 Months
Infections and infestations Cellulitis	1.9% 1/53 • Number of events 1 • 12 Months

Other adverse events

Measure	MIRODERM n=53 participants at risk Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix
Infections and infestations Cellulitis	7.5% 4/53 • Number of events 5 • 12 Months
Infections and infestations Infection	3.8% 2/53 • Number of events 2 • 12 Months
Skin and subcutaneous tissue disorders Increase in wound size	1.9% 1/53 • Number of events 1 • 12 Months
Infections and infestations Wound abscess	1.9% 1/53 • Number of events 1 • 12 Months
Infections and infestations Osteomyelitis	5.7% 3/53 • Number of events 3 • 12 Months

Additional Information

Head of Clinical Affairs

Miromatrix

Phone: 952.942-6000

Email: mmacenski@miromatrix.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place