Trial Outcomes & Findings for Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers (NCT NCT06403605)
NCT ID: NCT06403605
Last Updated: 2025-11-10
Results Overview
The proportion of subjects achieving complete wound closure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
148 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-11-10
Participant Flow
245 subjects were assessed for eligibility to participate in the study.
Participant milestones
| Measure |
SOC primary dressing with MIRRAGEN™
Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.
|
SOC primary dressing with FIBRACOL™
A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.
|
|---|---|---|
|
Randomization and Initial Treatment
STARTED
|
77
|
71
|
|
Randomization and Initial Treatment
COMPLETED
|
77
|
71
|
|
Randomization and Initial Treatment
NOT COMPLETED
|
0
|
0
|
|
Follow-up
STARTED
|
77
|
71
|
|
Follow-up
COMPLETED
|
52
|
43
|
|
Follow-up
NOT COMPLETED
|
25
|
28
|
Reasons for withdrawal
| Measure |
SOC primary dressing with MIRRAGEN™
Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.
|
SOC primary dressing with FIBRACOL™
A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.
|
|---|---|---|
|
Follow-up
Withdrawn per protocol with PAR <50% at week 6
|
17
|
19
|
|
Follow-up
Adverse Event
|
4
|
2
|
|
Follow-up
Withdrawal by Subject
|
2
|
3
|
|
Follow-up
Lost to Follow-up
|
1
|
0
|
|
Follow-up
Death
|
1
|
0
|
|
Follow-up
Other reasons
|
0
|
4
|
Baseline Characteristics
Both mITT and PP shown.
Baseline characteristics by cohort
| Measure |
SOC Primary Dressing With MIRRAGEN™
n=67 Participants
Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.
|
SOC Primary Dressing With FIBRACOL™
n=66 Participants
A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
mITT
|
60.1 years
STANDARD_DEVIATION 16.81 • n=67 Participants • Both mITT and PP shown.
|
59.1 years
STANDARD_DEVIATION 14.26 • n=66 Participants • Both mITT and PP shown.
|
59.6 years
STANDARD_DEVIATION 15.50 • n=133 Participants • Both mITT and PP shown.
|
|
Age, Continuous
PP
|
60.2 years
STANDARD_DEVIATION 16.34 • n=44 Participants • Both mITT and PP shown.
|
57.7 years
STANDARD_DEVIATION 15.60 • n=38 Participants • Both mITT and PP shown.
|
59.1 years
STANDARD_DEVIATION 15.95 • n=82 Participants • Both mITT and PP shown.
|
|
Sex: Female, Male
mITT · Female
|
20 Participants
n=67 Participants • Both mITT and PP shown.
|
18 Participants
n=66 Participants • Both mITT and PP shown.
|
38 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Sex: Female, Male
mITT · Male
|
47 Participants
n=67 Participants • Both mITT and PP shown.
|
48 Participants
n=66 Participants • Both mITT and PP shown.
|
95 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Sex: Female, Male
PP · Female
|
11 Participants
n=44 Participants • Both mITT and PP shown.
|
9 Participants
n=38 Participants • Both mITT and PP shown.
|
20 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Sex: Female, Male
PP · Male
|
33 Participants
n=44 Participants • Both mITT and PP shown.
|
29 Participants
n=38 Participants • Both mITT and PP shown.
|
62 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Race (NIH/OMB)
mITT · American Indian or Alaska Native
|
0 Participants
n=67 Participants • Both mITT and PP shown.
|
0 Participants
n=66 Participants • Both mITT and PP shown.
|
0 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Race (NIH/OMB)
mITT · Asian
|
1 Participants
n=67 Participants • Both mITT and PP shown.
|
0 Participants
n=66 Participants • Both mITT and PP shown.
|
1 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Race (NIH/OMB)
mITT · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=67 Participants • Both mITT and PP shown.
|
0 Participants
n=66 Participants • Both mITT and PP shown.
|
0 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Race (NIH/OMB)
mITT · Black or African American
|
7 Participants
n=67 Participants • Both mITT and PP shown.
|
4 Participants
n=66 Participants • Both mITT and PP shown.
|
11 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Race (NIH/OMB)
mITT · White
|
57 Participants
n=67 Participants • Both mITT and PP shown.
|
60 Participants
n=66 Participants • Both mITT and PP shown.
|
117 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Race (NIH/OMB)
mITT · More than one race
|
0 Participants
n=67 Participants • Both mITT and PP shown.
|
0 Participants
n=66 Participants • Both mITT and PP shown.
|
0 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Race (NIH/OMB)
mITT · Unknown or Not Reported
|
2 Participants
n=67 Participants • Both mITT and PP shown.
|
2 Participants
n=66 Participants • Both mITT and PP shown.
|
4 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Race (NIH/OMB)
PP · American Indian or Alaska Native
|
0 Participants
n=44 Participants • Both mITT and PP shown.
|
0 Participants
n=38 Participants • Both mITT and PP shown.
|
0 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Race (NIH/OMB)
PP · Asian
|
1 Participants
n=44 Participants • Both mITT and PP shown.
|
0 Participants
n=38 Participants • Both mITT and PP shown.
|
1 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Race (NIH/OMB)
PP · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=44 Participants • Both mITT and PP shown.
|
0 Participants
n=38 Participants • Both mITT and PP shown.
|
0 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Race (NIH/OMB)
PP · Black or African American
|
5 Participants
n=44 Participants • Both mITT and PP shown.
|
2 Participants
n=38 Participants • Both mITT and PP shown.
|
7 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Race (NIH/OMB)
PP · White
|
37 Participants
n=44 Participants • Both mITT and PP shown.
|
34 Participants
n=38 Participants • Both mITT and PP shown.
|
71 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Race (NIH/OMB)
PP · More than one race
|
0 Participants
n=44 Participants • Both mITT and PP shown.
|
0 Participants
n=38 Participants • Both mITT and PP shown.
|
0 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Race (NIH/OMB)
PP · Unknown or Not Reported
|
1 Participants
n=44 Participants • Both mITT and PP shown.
|
2 Participants
n=38 Participants • Both mITT and PP shown.
|
3 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Ethnicity (NIH/OMB)
mITT · Hispanic or Latino
|
19 Participants
n=67 Participants • Both mITT and PP shown.
|
14 Participants
n=66 Participants • Both mITT and PP shown.
|
33 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Ethnicity (NIH/OMB)
mITT · Not Hispanic or Latino
|
48 Participants
n=67 Participants • Both mITT and PP shown.
|
52 Participants
n=66 Participants • Both mITT and PP shown.
|
100 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Ethnicity (NIH/OMB)
mITT · Unknown or Not Reported
|
0 Participants
n=67 Participants • Both mITT and PP shown.
|
0 Participants
n=66 Participants • Both mITT and PP shown.
|
0 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Ethnicity (NIH/OMB)
PP · Hispanic or Latino
|
10 Participants
n=44 Participants • Both mITT and PP shown.
|
9 Participants
n=38 Participants • Both mITT and PP shown.
|
19 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Ethnicity (NIH/OMB)
PP · Not Hispanic or Latino
|
34 Participants
n=44 Participants • Both mITT and PP shown.
|
29 Participants
n=38 Participants • Both mITT and PP shown.
|
63 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Ethnicity (NIH/OMB)
PP · Unknown or Not Reported
|
0 Participants
n=44 Participants • Both mITT and PP shown.
|
0 Participants
n=38 Participants • Both mITT and PP shown.
|
0 Participants
n=82 Participants • Both mITT and PP shown.
|
|
BMI
mITT
|
33.9 kg/m²
STANDARD_DEVIATION 8.45 • n=67 Participants • Both mITT and PP shown.
|
35.0 kg/m²
STANDARD_DEVIATION 8.98 • n=66 Participants • Both mITT and PP shown.
|
34.5 kg/m²
STANDARD_DEVIATION 8.71 • n=133 Participants • Both mITT and PP shown.
|
|
BMI
PP
|
34.3 kg/m²
STANDARD_DEVIATION 9.06 • n=44 Participants • Both mITT and PP shown.
|
36.4 kg/m²
STANDARD_DEVIATION 9.99 • n=38 Participants • Both mITT and PP shown.
|
35.3 kg/m²
STANDARD_DEVIATION 9.50 • n=82 Participants • Both mITT and PP shown.
|
|
Tobacco use
mITT · Current
|
13 Participants
n=67 Participants • Both mITT and PP shown.
|
8 Participants
n=66 Participants • Both mITT and PP shown.
|
21 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Tobacco use
mITT · Former
|
20 Participants
n=67 Participants • Both mITT and PP shown.
|
22 Participants
n=66 Participants • Both mITT and PP shown.
|
42 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Tobacco use
mITT · Never used tobacco
|
34 Participants
n=67 Participants • Both mITT and PP shown.
|
36 Participants
n=66 Participants • Both mITT and PP shown.
|
70 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Tobacco use
PP · Current
|
8 Participants
n=44 Participants • Both mITT and PP shown.
|
4 Participants
n=38 Participants • Both mITT and PP shown.
|
12 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Tobacco use
PP · Former
|
13 Participants
n=44 Participants • Both mITT and PP shown.
|
15 Participants
n=38 Participants • Both mITT and PP shown.
|
28 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Tobacco use
PP · Never used tobacco
|
23 Participants
n=44 Participants • Both mITT and PP shown.
|
19 Participants
n=38 Participants • Both mITT and PP shown.
|
42 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Diabetes duration
mITT
|
17.1 years
STANDARD_DEVIATION 13.59 • n=67 Participants • Both mITT and PP shown.
|
15.9 years
STANDARD_DEVIATION 9.58 • n=66 Participants • Both mITT and PP shown.
|
16.5 years
STANDARD_DEVIATION 11.71 • n=133 Participants • Both mITT and PP shown.
|
|
Diabetes duration
PP
|
15.7 years
STANDARD_DEVIATION 9.75 • n=44 Participants • Both mITT and PP shown.
|
16.4 years
STANDARD_DEVIATION 14.18 • n=38 Participants • Both mITT and PP shown.
|
16.0 years
STANDARD_DEVIATION 11.93 • n=82 Participants • Both mITT and PP shown.
|
|
Age when first DFU appeared
mITT
|
58.2 years
STANDARD_DEVIATION 11.56 • n=67 Participants • Both mITT and PP shown.
|
53.6 years
STANDARD_DEVIATION 11.60 • n=66 Participants • Both mITT and PP shown.
|
55.9 years
STANDARD_DEVIATION 11.76 • n=133 Participants • Both mITT and PP shown.
|
|
Age when first DFU appeared
PP
|
58.9 years
STANDARD_DEVIATION 11.86 • n=44 Participants • Both mITT and PP shown.
|
54.4 years
STANDARD_DEVIATION 11.09 • n=38 Participants • Both mITT and PP shown.
|
56.8 years
STANDARD_DEVIATION 11.66 • n=82 Participants • Both mITT and PP shown.
|
|
Number of prior DFUs
mITT
|
3.1 DFUs
STANDARD_DEVIATION 4.27 • n=67 Participants • Both mITT and PP shown.
|
4.4 DFUs
STANDARD_DEVIATION 4.96 • n=66 Participants • Both mITT and PP shown.
|
3.8 DFUs
STANDARD_DEVIATION 4.66 • n=133 Participants • Both mITT and PP shown.
|
|
Number of prior DFUs
PP
|
2.5 DFUs
STANDARD_DEVIATION 2.95 • n=44 Participants • Both mITT and PP shown.
|
3.6 DFUs
STANDARD_DEVIATION 3.77 • n=38 Participants • Both mITT and PP shown.
|
3.0 DFUs
STANDARD_DEVIATION 3.38 • n=82 Participants • Both mITT and PP shown.
|
|
Number of other concurrent DFUs at screening
mITT · 0
|
48 Participants
n=67 Participants • Both mITT and PP shown.
|
53 Participants
n=66 Participants • Both mITT and PP shown.
|
101 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Number of other concurrent DFUs at screening
mITT · 1
|
1 Participants
n=67 Participants • Both mITT and PP shown.
|
0 Participants
n=66 Participants • Both mITT and PP shown.
|
1 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Number of other concurrent DFUs at screening
mITT · 2
|
15 Participants
n=67 Participants • Both mITT and PP shown.
|
9 Participants
n=66 Participants • Both mITT and PP shown.
|
24 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Number of other concurrent DFUs at screening
mITT · 3 or more
|
3 Participants
n=67 Participants • Both mITT and PP shown.
|
4 Participants
n=66 Participants • Both mITT and PP shown.
|
7 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Number of other concurrent DFUs at screening
PP · 0
|
32 Participants
n=44 Participants • Both mITT and PP shown.
|
29 Participants
n=38 Participants • Both mITT and PP shown.
|
61 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Number of other concurrent DFUs at screening
PP · 1
|
0 Participants
n=44 Participants • Both mITT and PP shown.
|
0 Participants
n=38 Participants • Both mITT and PP shown.
|
0 Participants
n=82 Participants • Both mITT and PP shown.
|
|
HbA1c
PP
|
7.7 %
STANDARD_DEVIATION 1.61 • n=44 Participants • Both mITT and PP shown.
|
7.4 %
STANDARD_DEVIATION 1.57 • n=38 Participants • Both mITT and PP shown.
|
7.6 %
STANDARD_DEVIATION 1.60 • n=82 Participants • Both mITT and PP shown.
|
|
Number of other concurrent DFUs at screening
PP · 2
|
11 Participants
n=44 Participants • Both mITT and PP shown.
|
7 Participants
n=38 Participants • Both mITT and PP shown.
|
18 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Number of other concurrent DFUs at screening
PP · 3 or more
|
1 Participants
n=44 Participants • Both mITT and PP shown.
|
2 Participants
n=38 Participants • Both mITT and PP shown.
|
3 Participants
n=82 Participants • Both mITT and PP shown.
|
|
History of DFU recurrence
mITT
|
32 Participants
n=67 Participants • Both mITT and PP shown.
|
31 Participants
n=66 Participants • Both mITT and PP shown.
|
63 Participants
n=133 Participants • Both mITT and PP shown.
|
|
History of DFU recurrence
PP
|
18 Participants
n=44 Participants • Both mITT and PP shown.
|
16 Participants
n=38 Participants • Both mITT and PP shown.
|
34 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Major amputation
mITT
|
2 Participants
n=67 Participants • Both mITT and PP shown.
|
5 Participants
n=66 Participants • Both mITT and PP shown.
|
7 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Major amputation
PP
|
1 Participants
n=44 Participants • Both mITT and PP shown.
|
4 Participants
n=38 Participants • Both mITT and PP shown.
|
5 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Minor amputations
mITT · 0
|
41 Participants
n=67 Participants • Both mITT and PP shown.
|
37 Participants
n=66 Participants • Both mITT and PP shown.
|
78 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Minor amputations
mITT · 1
|
11 Participants
n=67 Participants • Both mITT and PP shown.
|
14 Participants
n=66 Participants • Both mITT and PP shown.
|
25 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Minor amputations
mITT · 2
|
5 Participants
n=67 Participants • Both mITT and PP shown.
|
7 Participants
n=66 Participants • Both mITT and PP shown.
|
12 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Minor amputations
mITT · 3 or more
|
10 Participants
n=67 Participants • Both mITT and PP shown.
|
8 Participants
n=66 Participants • Both mITT and PP shown.
|
18 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Minor amputations
PP · 0
|
31 Participants
n=44 Participants • Both mITT and PP shown.
|
21 Participants
n=38 Participants • Both mITT and PP shown.
|
52 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Minor amputations
PP · 1
|
6 Participants
n=44 Participants • Both mITT and PP shown.
|
10 Participants
n=38 Participants • Both mITT and PP shown.
|
16 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Minor amputations
PP · 2
|
3 Participants
n=44 Participants • Both mITT and PP shown.
|
3 Participants
n=38 Participants • Both mITT and PP shown.
|
6 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Minor amputations
PP · 3 or more
|
4 Participants
n=44 Participants • Both mITT and PP shown.
|
4 Participants
n=38 Participants • Both mITT and PP shown.
|
8 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Major foot deformities
mITT · Charcot
|
5 Participants
n=67 Participants • Both mITT and PP shown.
|
8 Participants
n=66 Participants • Both mITT and PP shown.
|
13 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Major foot deformities
mITT · Hammertoe
|
2 Participants
n=67 Participants • Both mITT and PP shown.
|
1 Participants
n=66 Participants • Both mITT and PP shown.
|
3 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Major foot deformities
mITT · Varus ankle
|
1 Participants
n=67 Participants • Both mITT and PP shown.
|
0 Participants
n=66 Participants • Both mITT and PP shown.
|
1 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Major foot deformities
mITT · Hallux valgis
|
2 Participants
n=67 Participants • Both mITT and PP shown.
|
1 Participants
n=66 Participants • Both mITT and PP shown.
|
3 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Major foot deformities
mITT · Cavus foot
|
3 Participants
n=67 Participants • Both mITT and PP shown.
|
1 Participants
n=66 Participants • Both mITT and PP shown.
|
4 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Major foot deformities
mITT · None of the above
|
54 Participants
n=67 Participants • Both mITT and PP shown.
|
55 Participants
n=66 Participants • Both mITT and PP shown.
|
109 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Major foot deformities
PP · Charcot
|
1 Participants
n=44 Participants • Both mITT and PP shown.
|
4 Participants
n=38 Participants • Both mITT and PP shown.
|
5 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Major foot deformities
PP · Hammertoe
|
1 Participants
n=44 Participants • Both mITT and PP shown.
|
1 Participants
n=38 Participants • Both mITT and PP shown.
|
2 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Major foot deformities
PP · Varus ankle
|
0 Participants
n=44 Participants • Both mITT and PP shown.
|
0 Participants
n=38 Participants • Both mITT and PP shown.
|
0 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Major foot deformities
PP · Hallux valgis
|
2 Participants
n=44 Participants • Both mITT and PP shown.
|
1 Participants
n=38 Participants • Both mITT and PP shown.
|
3 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Major foot deformities
PP · Cavus foot
|
2 Participants
n=44 Participants • Both mITT and PP shown.
|
1 Participants
n=38 Participants • Both mITT and PP shown.
|
3 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Major foot deformities
PP · None of the above
|
38 Participants
n=44 Participants • Both mITT and PP shown.
|
31 Participants
n=38 Participants • Both mITT and PP shown.
|
69 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Creatinine
mITT
|
1.09 mg/dL
STANDARD_DEVIATION 0.42 • n=67 Participants • Both mITT and PP shown.
|
1.24 mg/dL
STANDARD_DEVIATION 0.54 • n=66 Participants • Both mITT and PP shown.
|
1.2 mg/dL
STANDARD_DEVIATION 0.49 • n=133 Participants • Both mITT and PP shown.
|
|
Creatinine
PP
|
1.09 mg/dL
STANDARD_DEVIATION 0.46 • n=44 Participants • Both mITT and PP shown.
|
1.19 mg/dL
STANDARD_DEVIATION 0.46 • n=38 Participants • Both mITT and PP shown.
|
1.1 mg/dL
STANDARD_DEVIATION 0.46 • n=82 Participants • Both mITT and PP shown.
|
|
HbA1c
mITT
|
7.7 %
STANDARD_DEVIATION 1.69 • n=67 Participants • Both mITT and PP shown.
|
7.4 %
STANDARD_DEVIATION 1.65 • n=66 Participants • Both mITT and PP shown.
|
7.6 %
STANDARD_DEVIATION 1.67 • n=133 Participants • Both mITT and PP shown.
|
|
Wound area
mITT
|
3.1 cm^2
STANDARD_DEVIATION 2.81 • n=67 Participants • Both mITT and PP shown.
|
3.3 cm^2
STANDARD_DEVIATION 2.57 • n=66 Participants • Both mITT and PP shown.
|
3.2 cm^2
STANDARD_DEVIATION 2.69 • n=133 Participants • Both mITT and PP shown.
|
|
Wound area
PP
|
2.7 cm^2
STANDARD_DEVIATION 2.37 • n=44 Participants • Both mITT and PP shown.
|
3.1 cm^2
STANDARD_DEVIATION 2.43 • n=38 Participants • Both mITT and PP shown.
|
2.9 cm^2
STANDARD_DEVIATION 2.39 • n=82 Participants • Both mITT and PP shown.
|
|
Wound age
mITT
|
20.9 weeks
STANDARD_DEVIATION 13.26 • n=67 Participants • Both mITT and PP shown.
|
20.9 weeks
STANDARD_DEVIATION 14.82 • n=66 Participants • Both mITT and PP shown.
|
20.9 weeks
STANDARD_DEVIATION 14.00 • n=133 Participants • Both mITT and PP shown.
|
|
Wound age
PP
|
19.4 weeks
STANDARD_DEVIATION 12.99 • n=44 Participants • Both mITT and PP shown.
|
21.3 weeks
STANDARD_DEVIATION 14.55 • n=38 Participants • Both mITT and PP shown.
|
20.3 weeks
STANDARD_DEVIATION 13.69 • n=82 Participants • Both mITT and PP shown.
|
|
Number of participants with index wound in each vertical location
mITT · Plantar
|
52 Participants
n=67 Participants • Both mITT and PP shown.
|
54 Participants
n=66 Participants • Both mITT and PP shown.
|
106 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Number of participants with index wound in each vertical location
mITT · Dorsal
|
15 Participants
n=67 Participants • Both mITT and PP shown.
|
12 Participants
n=66 Participants • Both mITT and PP shown.
|
27 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Number of participants with index wound in each vertical location
PP · Plantar
|
34 Participants
n=44 Participants • Both mITT and PP shown.
|
29 Participants
n=38 Participants • Both mITT and PP shown.
|
63 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Number of participants with index wound in each vertical location
PP · Dorsal
|
10 Participants
n=44 Participants • Both mITT and PP shown.
|
9 Participants
n=38 Participants • Both mITT and PP shown.
|
19 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Number of participants with index wound in each position
mITT · Medial
|
35 Participants
n=67 Participants • Both mITT and PP shown.
|
37 Participants
n=66 Participants • Both mITT and PP shown.
|
72 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Number of participants with index wound in each position
mITT · Lateral
|
32 Participants
n=67 Participants • Both mITT and PP shown.
|
28 Participants
n=66 Participants • Both mITT and PP shown.
|
60 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Number of participants with index wound in each position
mITT · Unknown
|
0 Participants
n=67 Participants • Both mITT and PP shown.
|
1 Participants
n=66 Participants • Both mITT and PP shown.
|
1 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Number of participants with index wound in each position
PP · Medial
|
26 Participants
n=44 Participants • Both mITT and PP shown.
|
20 Participants
n=38 Participants • Both mITT and PP shown.
|
46 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Number of participants with index wound in each position
PP · Lateral
|
18 Participants
n=44 Participants • Both mITT and PP shown.
|
17 Participants
n=38 Participants • Both mITT and PP shown.
|
35 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Number of participants with index wound in each position
PP · Unknown
|
0 Participants
n=44 Participants • Both mITT and PP shown.
|
1 Participants
n=38 Participants • Both mITT and PP shown.
|
1 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Number of participants with index wound in each anatomical location
mITT · Toe
|
13 Participants
n=67 Participants • Both mITT and PP shown.
|
10 Participants
n=66 Participants • Both mITT and PP shown.
|
23 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Number of participants with index wound in each anatomical location
mITT · Forefoot
|
29 Participants
n=67 Participants • Both mITT and PP shown.
|
24 Participants
n=66 Participants • Both mITT and PP shown.
|
53 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Number of participants with index wound in each anatomical location
mITT · Midfoot
|
12 Participants
n=67 Participants • Both mITT and PP shown.
|
17 Participants
n=66 Participants • Both mITT and PP shown.
|
29 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Number of participants with index wound in each anatomical location
mITT · Hindfoot
|
2 Participants
n=67 Participants • Both mITT and PP shown.
|
2 Participants
n=66 Participants • Both mITT and PP shown.
|
4 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Off-loading type
PP · CAM boot
|
21 Participants
n=44 Participants • Both mITT and PP shown.
|
14 Participants
n=38 Participants • Both mITT and PP shown.
|
35 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Number of participants with index wound in each anatomical location
mITT · Heel
|
9 Participants
n=67 Participants • Both mITT and PP shown.
|
10 Participants
n=66 Participants • Both mITT and PP shown.
|
19 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Number of participants with index wound in each anatomical location
mITT · Ankle
|
2 Participants
n=67 Participants • Both mITT and PP shown.
|
3 Participants
n=66 Participants • Both mITT and PP shown.
|
5 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Number of participants with index wound in each anatomical location
PP · Toe
|
13 Participants
n=44 Participants • Both mITT and PP shown.
|
6 Participants
n=38 Participants • Both mITT and PP shown.
|
19 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Number of participants with index wound in each anatomical location
PP · Forefoot
|
18 Participants
n=44 Participants • Both mITT and PP shown.
|
15 Participants
n=38 Participants • Both mITT and PP shown.
|
33 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Number of participants with index wound in each anatomical location
PP · Midfoot
|
5 Participants
n=44 Participants • Both mITT and PP shown.
|
7 Participants
n=38 Participants • Both mITT and PP shown.
|
12 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Off-loading type
PP · Shoe
|
4 Participants
n=44 Participants • Both mITT and PP shown.
|
3 Participants
n=38 Participants • Both mITT and PP shown.
|
7 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Number of participants with index wound in each anatomical location
PP · Hindfoot
|
1 Participants
n=44 Participants • Both mITT and PP shown.
|
1 Participants
n=38 Participants • Both mITT and PP shown.
|
2 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Number of participants with index wound in each anatomical location
PP · Heel
|
6 Participants
n=44 Participants • Both mITT and PP shown.
|
6 Participants
n=38 Participants • Both mITT and PP shown.
|
12 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Number of participants with index wound in each anatomical location
PP · Ankle
|
1 Participants
n=44 Participants • Both mITT and PP shown.
|
3 Participants
n=38 Participants • Both mITT and PP shown.
|
4 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Off-loading type
mITT · Boot
|
10 Participants
n=67 Participants • Both mITT and PP shown.
|
11 Participants
n=66 Participants • Both mITT and PP shown.
|
21 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Off-loading type
mITT · CAM boot
|
28 Participants
n=67 Participants • Both mITT and PP shown.
|
31 Participants
n=66 Participants • Both mITT and PP shown.
|
59 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Off-loading type
mITT · Shoe
|
10 Participants
n=67 Participants • Both mITT and PP shown.
|
9 Participants
n=66 Participants • Both mITT and PP shown.
|
19 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Off-loading type
mITT · Other
|
5 Participants
n=67 Participants • Both mITT and PP shown.
|
2 Participants
n=66 Participants • Both mITT and PP shown.
|
7 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Off-loading type
mITT · No off-loading
|
14 Participants
n=67 Participants • Both mITT and PP shown.
|
13 Participants
n=66 Participants • Both mITT and PP shown.
|
27 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Off-loading type
PP · Boot
|
6 Participants
n=44 Participants • Both mITT and PP shown.
|
10 Participants
n=38 Participants • Both mITT and PP shown.
|
16 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Off-loading type
PP · Other
|
3 Participants
n=44 Participants • Both mITT and PP shown.
|
2 Participants
n=38 Participants • Both mITT and PP shown.
|
5 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Off-loading type
PP · No off-loading
|
10 Participants
n=44 Participants • Both mITT and PP shown.
|
9 Participants
n=38 Participants • Both mITT and PP shown.
|
19 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Number of debridements
mITT
|
9.0 debridements
STANDARD_DEVIATION 3.54 • n=67 Participants • Both mITT and PP shown.
|
9.2 debridements
STANDARD_DEVIATION 3.34 • n=66 Participants • Both mITT and PP shown.
|
9.1 debridements
STANDARD_DEVIATION 3.43 • n=133 Participants • Both mITT and PP shown.
|
|
Number of debridements
PP
|
9.4 debridements
STANDARD_DEVIATION 4.09 • n=44 Participants • Both mITT and PP shown.
|
9.7 debridements
STANDARD_DEVIATION 3.85 • n=38 Participants • Both mITT and PP shown.
|
9.6 debridements
STANDARD_DEVIATION 3.96 • n=82 Participants • Both mITT and PP shown.
|
|
Number of comorbidities
mITT
|
7.1 comorbidities
STANDARD_DEVIATION 5.48 • n=67 Participants • Both mITT and PP shown.
|
7.9 comorbidities
STANDARD_DEVIATION 4.29 • n=66 Participants • Both mITT and PP shown.
|
7.5 comorbidities
STANDARD_DEVIATION 4.92 • n=133 Participants • Both mITT and PP shown.
|
|
Number of comorbidities
PP
|
6.3 comorbidities
STANDARD_DEVIATION 4.50 • n=44 Participants • Both mITT and PP shown.
|
8.0 comorbidities
STANDARD_DEVIATION 4.32 • n=38 Participants • Both mITT and PP shown.
|
7.1 comorbidities
STANDARD_DEVIATION 4.47 • n=82 Participants • Both mITT and PP shown.
|
|
Comorbidities: chronic kidney disease (CKD)
mITT
|
4 Participants
n=67 Participants • Both mITT and PP shown.
|
11 Participants
n=66 Participants • Both mITT and PP shown.
|
15 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Comorbidities: chronic kidney disease (CKD)
PP
|
3 Participants
n=44 Participants • Both mITT and PP shown.
|
5 Participants
n=38 Participants • Both mITT and PP shown.
|
8 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Comorbidities: hypertension
mITT
|
41 Participants
n=67 Participants • Both mITT and PP shown.
|
49 Participants
n=66 Participants • Both mITT and PP shown.
|
90 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Comorbidities: hypertension
PP
|
25 Participants
n=44 Participants • Both mITT and PP shown.
|
25 Participants
n=38 Participants • Both mITT and PP shown.
|
50 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Comorbidities: peripheral arterial disease (PAD) / peripheral vascular disease (PVD)
mITT
|
7 Participants
n=67 Participants • Both mITT and PP shown.
|
5 Participants
n=66 Participants • Both mITT and PP shown.
|
12 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Comorbidities: peripheral arterial disease (PAD) / peripheral vascular disease (PVD)
PP
|
5 Participants
n=44 Participants • Both mITT and PP shown.
|
5 Participants
n=38 Participants • Both mITT and PP shown.
|
10 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Comorbidities: chronic heart failure (CHF)
mITT
|
4 Participants
n=67 Participants • Both mITT and PP shown.
|
3 Participants
n=66 Participants • Both mITT and PP shown.
|
7 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Comorbidities: chronic heart failure (CHF)
PP
|
4 Participants
n=44 Participants • Both mITT and PP shown.
|
2 Participants
n=38 Participants • Both mITT and PP shown.
|
6 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Comorbidities: hyperlipidemia / dyslipidemia
mITT
|
20 Participants
n=67 Participants • Both mITT and PP shown.
|
24 Participants
n=66 Participants • Both mITT and PP shown.
|
44 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Comorbidities: hyperlipidemia / dyslipidemia
PP
|
14 Participants
n=44 Participants • Both mITT and PP shown.
|
11 Participants
n=38 Participants • Both mITT and PP shown.
|
25 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Comorbidities: gastroesophageal reflux disease (GERD)
mITT
|
13 Participants
n=67 Participants • Both mITT and PP shown.
|
17 Participants
n=66 Participants • Both mITT and PP shown.
|
30 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Comorbidities: gastroesophageal reflux disease (GERD)
PP
|
11 Participants
n=44 Participants • Both mITT and PP shown.
|
7 Participants
n=38 Participants • Both mITT and PP shown.
|
18 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Comorbidities: hypothyroidism
mITT
|
9 Participants
n=67 Participants • Both mITT and PP shown.
|
11 Participants
n=66 Participants • Both mITT and PP shown.
|
20 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Comorbidities: hypothyroidism
PP
|
7 Participants
n=44 Participants • Both mITT and PP shown.
|
6 Participants
n=38 Participants • Both mITT and PP shown.
|
13 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Comorbidities: lower extremity edema
mITT
|
4 Participants
n=67 Participants • Both mITT and PP shown.
|
6 Participants
n=66 Participants • Both mITT and PP shown.
|
10 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Comorbidities: lower extremity edema
PP
|
4 Participants
n=44 Participants • Both mITT and PP shown.
|
1 Participants
n=38 Participants • Both mITT and PP shown.
|
5 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Comorbidities: peripheral neuropathy
mITT
|
27 Participants
n=67 Participants • Both mITT and PP shown.
|
34 Participants
n=66 Participants • Both mITT and PP shown.
|
61 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Comorbidities: peripheral neuropathy
PP
|
19 Participants
n=44 Participants • Both mITT and PP shown.
|
17 Participants
n=38 Participants • Both mITT and PP shown.
|
36 Participants
n=82 Participants • Both mITT and PP shown.
|
|
Comorbidities: any psychiatric condition
mITT
|
17 Participants
n=67 Participants • Both mITT and PP shown.
|
22 Participants
n=66 Participants • Both mITT and PP shown.
|
39 Participants
n=133 Participants • Both mITT and PP shown.
|
|
Comorbidities: any psychiatric condition
PP
|
13 Participants
n=44 Participants • Both mITT and PP shown.
|
13 Participants
n=38 Participants • Both mITT and PP shown.
|
26 Participants
n=82 Participants • Both mITT and PP shown.
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Both the modified intent-to-treat (mITT) and per protocol (PP) analysis populations are represented.
The proportion of subjects achieving complete wound closure.
Outcome measures
| Measure |
SOC primary dressing with MIRRAGEN™
n=67 Participants
Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.
|
SOC primary dressing with FIBRACOL™
n=66 Participants
A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.
|
|---|---|---|
|
Complete Wound Healing
mITT
|
32 Participants
|
16 Participants
|
|
Complete Wound Healing
PP
|
32 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Both the modified intent-to-treat (mITT) and per protocol (PP) analysis populations are represented.
Percentage wound area reduction measured weekly with digital photographic planimetry and physical examination
Outcome measures
| Measure |
SOC primary dressing with MIRRAGEN™
n=67 Participants
Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.
|
SOC primary dressing with FIBRACOL™
n=66 Participants
A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.
|
|---|---|---|
|
Percentage Area Reduction (PAR)
mITT
|
48.8 percent
Standard Deviation 82.81
|
53.7 percent
Standard Deviation 65.78
|
|
Percentage Area Reduction (PAR)
PP
|
93.7 percent
Standard Deviation 15.28
|
89.7 percent
Standard Deviation 25.19
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Both the modified intent-to-treat (mITT) and per protocol (PP) analysis populations are represented.
The time to achieve complete wound closure within 12 weeks.
Outcome measures
| Measure |
SOC primary dressing with MIRRAGEN™
n=67 Participants
Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.
|
SOC primary dressing with FIBRACOL™
n=66 Participants
A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.
|
|---|---|---|
|
Time to Heal
mITT
|
63.4 days
Interval 56.6 to 70.1
|
72.5 days
Interval 67.3 to 77.7
|
|
Time to Heal
PP
|
57.5 days
Interval 49.3 to 65.7
|
67.8 days
Interval 60.5 to 75.2
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Both the modified intent-to-treat (mITT) and per protocol (PP) analysis populations are represented.
The WOUND-Q is a questionnaire measuring outcomes important to patients with chronic wounds. Five of the tool's 13 independently functioning scales (with 5 to 11 items each) were measured in this study. 'Assessment' measures how concerned someone has been with their wound(s). 'Drainage' measures how bothered someone has been by drainage from their wound(s). 'Smell' measures how bothered someone has been by the smell from their wound(s). 'Social' measures the impact of a person's wound(s) on their social life. 'Dressing' measures someone's satisfaction with their wound dressing. For all of these scales, possible responses to each item range from minimum 0 ('not at all') to maximum 4 ('very much'). To score a scale, the raw scores for the set of items in a scale are added together to produce a total raw score. The total raw score for the scale is then converted to a score that ranges from 0 to 100. For all, higher scores represent better outcomes.
Outcome measures
| Measure |
SOC primary dressing with MIRRAGEN™
n=67 Participants
Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.
|
SOC primary dressing with FIBRACOL™
n=66 Participants
A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.
|
|---|---|---|
|
Changes in Quality of Life
Assessment (mITT)
|
18.3 units on a scale
Standard Deviation 20.68
|
17.0 units on a scale
Standard Deviation 21.36
|
|
Changes in Quality of Life
Drainage (mITT)
|
16.6 units on a scale
Standard Deviation 22.77
|
11.8 units on a scale
Standard Deviation 20.83
|
|
Changes in Quality of Life
Smell (mITT)
|
4.5 units on a scale
Standard Deviation 23.06
|
1.4 units on a scale
Standard Deviation 18.42
|
|
Changes in Quality of Life
Social (mITT)
|
11.6 units on a scale
Standard Deviation 28.14
|
15.2 units on a scale
Standard Deviation 26.27
|
|
Changes in Quality of Life
Dressing (mITT)
|
9.0 units on a scale
Standard Deviation 21.08
|
7.1 units on a scale
Standard Deviation 18.04
|
|
Changes in Quality of Life
Assessment (PP)
|
28.1 units on a scale
Standard Deviation 17.89
|
24.6 units on a scale
Standard Deviation 21.34
|
|
Changes in Quality of Life
Drainage (PP)
|
25.3 units on a scale
Standard Deviation 19.58
|
17.6 units on a scale
Standard Deviation 18.57
|
|
Changes in Quality of Life
Smell (PP)
|
8.1 units on a scale
Standard Deviation 20.73
|
3.4 units on a scale
Standard Deviation 17.59
|
|
Changes in Quality of Life
Social (PP)
|
17.4 units on a scale
Standard Deviation 29.39
|
19.0 units on a scale
Standard Deviation 25.53
|
|
Changes in Quality of Life
Dressing (PP)
|
14.2 units on a scale
Standard Deviation 20.85
|
7.7 units on a scale
Standard Deviation 18.55
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Both the modified intent-to-treat (mITT) and per protocol (PP) analysis populations are represented.
The FACES pain scale was administered to the clinical trial participants at each visit. The trial participant selected their pain level with a series of faces that correspond to a number between 0 which implies no pain, up to 10 which implies the most severe pain.
Outcome measures
| Measure |
SOC primary dressing with MIRRAGEN™
n=67 Participants
Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.
|
SOC primary dressing with FIBRACOL™
n=66 Participants
A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.
|
|---|---|---|
|
Change in Pain Level
mITT
|
0.5 score change [EOS - baseline]
Standard Deviation 2.47
|
0.8 score change [EOS - baseline]
Standard Deviation 2.27
|
|
Change in Pain Level
PP
|
0.9 score change [EOS - baseline]
Standard Deviation 2.24
|
1.0 score change [EOS - baseline]
Standard Deviation 2.44
|
Adverse Events
SOC primary dressing with MIRRAGEN™
Serious events: 6 serious events
Other events: 5 other events
Deaths: 1 deaths
SOC primary dressing with FIBRACOL™
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOC primary dressing with MIRRAGEN™
n=67 participants at risk
Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.
|
SOC primary dressing with FIBRACOL™
n=66 participants at risk
A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.
|
|---|---|---|
|
Renal and urinary disorders
Cystitis
|
1.5%
1/67 • Number of events 1 • From enrollment until end of follow-up (up to 12 weeks)
|
0.00%
0/66 • From enrollment until end of follow-up (up to 12 weeks)
|
|
Infections and infestations
Deep space infection of left plantar mid foot
|
1.5%
1/67 • Number of events 1 • From enrollment until end of follow-up (up to 12 weeks)
|
0.00%
0/66 • From enrollment until end of follow-up (up to 12 weeks)
|
|
Infections and infestations
Osteomyelitis of sacrum
|
1.5%
1/67 • Number of events 1 • From enrollment until end of follow-up (up to 12 weeks)
|
0.00%
0/66 • From enrollment until end of follow-up (up to 12 weeks)
|
|
Infections and infestations
Postoperative infection of non-study wound
|
1.5%
1/67 • Number of events 1 • From enrollment until end of follow-up (up to 12 weeks)
|
0.00%
0/66 • From enrollment until end of follow-up (up to 12 weeks)
|
|
Infections and infestations
Necrotizing fasciitis
|
1.5%
1/67 • Number of events 1 • From enrollment until end of follow-up (up to 12 weeks)
|
0.00%
0/66 • From enrollment until end of follow-up (up to 12 weeks)
|
|
Infections and infestations
Non-study diabetic foot wound infection with osteomyelitis
|
1.5%
1/67 • Number of events 1 • From enrollment until end of follow-up (up to 12 weeks)
|
0.00%
0/66 • From enrollment until end of follow-up (up to 12 weeks)
|
|
General disorders
Death (due to underlying comorbidities)
|
1.5%
1/67 • Number of events 1 • From enrollment until end of follow-up (up to 12 weeks)
|
0.00%
0/66 • From enrollment until end of follow-up (up to 12 weeks)
|
|
Infections and infestations
Septicemia (gram negative, from right foot abscess/cellulitis)
|
1.5%
1/67 • Number of events 1 • From enrollment until end of follow-up (up to 12 weeks)
|
0.00%
0/66 • From enrollment until end of follow-up (up to 12 weeks)
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
1/67 • Number of events 1 • From enrollment until end of follow-up (up to 12 weeks)
|
0.00%
0/66 • From enrollment until end of follow-up (up to 12 weeks)
|
|
Nervous system disorders
Acute toxic encephalopathy
|
1.5%
1/67 • Number of events 1 • From enrollment until end of follow-up (up to 12 weeks)
|
0.00%
0/66 • From enrollment until end of follow-up (up to 12 weeks)
|
|
Infections and infestations
Cellulitis, right leg
|
0.00%
0/67 • From enrollment until end of follow-up (up to 12 weeks)
|
1.5%
1/66 • Number of events 1 • From enrollment until end of follow-up (up to 12 weeks)
|
|
Cardiac disorders
Anasarca
|
0.00%
0/67 • From enrollment until end of follow-up (up to 12 weeks)
|
1.5%
1/66 • Number of events 1 • From enrollment until end of follow-up (up to 12 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral pleural effusions
|
0.00%
0/67 • From enrollment until end of follow-up (up to 12 weeks)
|
1.5%
1/66 • Number of events 1 • From enrollment until end of follow-up (up to 12 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/67 • From enrollment until end of follow-up (up to 12 weeks)
|
1.5%
1/66 • Number of events 1 • From enrollment until end of follow-up (up to 12 weeks)
|
Other adverse events
| Measure |
SOC primary dressing with MIRRAGEN™
n=67 participants at risk
Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.
|
SOC primary dressing with FIBRACOL™
n=66 participants at risk
A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing.
|
|---|---|---|
|
Infections and infestations
Index wound infection
|
7.5%
5/67 • Number of events 5 • From enrollment until end of follow-up (up to 12 weeks)
|
7.6%
5/66 • Number of events 5 • From enrollment until end of follow-up (up to 12 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place