Trial Outcomes & Findings for VA MERIT: A Comparative Efficacy Study: Treatment of Non-Healing Diabetic (NCT NCT01450943)
NCT ID: NCT01450943
Last Updated: 2019-09-17
Results Overview
The primary outcome of interest is defined as the wound healed completely on or before visit 15, regardless of a later recurrence.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
120 participants
Primary outcome timeframe
15 weeks
Results posted on
2019-09-17
Participant Flow
120 subjects enrolled from which 2 study subjects were not randomized into any groups and were terminated from the study; therefore, we only had overall of 118 study subjects.
Participant milestones
| Measure |
Standard of Care
Consist of subjects who were randomized to treatment with standard of Care (SOC) which included debridement, irritation, primary dressing, Adaptic, secondary dressing gauze and tape.
|
Dermagraft
These are study subject who were randomized to treatment arm with Dermagraft. Dermagraft is a cryopreserved human fibroblast-derived dermal substitute composed of viable newborn foreskin fibroblasts, seeded onto a bio-absorbable polyglactin mesh.
The treatment included debridement, irrigation, primary dressing and Dermagraft and Adaptic, and secondary dressing with gauze and tape.
Dermagraft placed per company protocol
|
Oasis
These are study subject who were randomized to treatment arm with Oasis. Oasis is a bio-absorbable ECM derived from porcine small intestinal submucosa. the product is processed using proprietary methods to retain its original structure while stored at room temperature.
The treatment included debridement, irrigation, primary dressing and Oasis and Adaptic, and secondary dressing with gauze and tape.
Oasis placed per company protocol
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
42
|
48
|
|
Overall Study
COMPLETED
|
26
|
35
|
42
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
6
|
Reasons for withdrawal
| Measure |
Standard of Care
Consist of subjects who were randomized to treatment with standard of Care (SOC) which included debridement, irritation, primary dressing, Adaptic, secondary dressing gauze and tape.
|
Dermagraft
These are study subject who were randomized to treatment arm with Dermagraft. Dermagraft is a cryopreserved human fibroblast-derived dermal substitute composed of viable newborn foreskin fibroblasts, seeded onto a bio-absorbable polyglactin mesh.
The treatment included debridement, irrigation, primary dressing and Dermagraft and Adaptic, and secondary dressing with gauze and tape.
Dermagraft placed per company protocol
|
Oasis
These are study subject who were randomized to treatment arm with Oasis. Oasis is a bio-absorbable ECM derived from porcine small intestinal submucosa. the product is processed using proprietary methods to retain its original structure while stored at room temperature.
The treatment included debridement, irrigation, primary dressing and Oasis and Adaptic, and secondary dressing with gauze and tape.
Oasis placed per company protocol
|
|---|---|---|---|
|
Overall Study
Screen failure, loss to follow-up
|
2
|
7
|
6
|
Baseline Characteristics
Northern California veteran patient population
Baseline characteristics by cohort
| Measure |
Standard of Care
n=28 Participants
Consist of subjects who were randomized to treatment with standard of Care (SOC) which included debridement, irritation, primary dressing, Adaptic, secondary dressing gauze and tape.
|
Dermagraft
n=42 Participants
Study subjects who were randomized to treatment arm with Dermagraft. Dermagraft is a cryopreserved human fibroblast-derived dermal substitute composed of viable newborn foreskin fibroblasts, seeded onto a bio-absorbable polyglactin mesh.
The treatment included debridement, irrigation, primary dressing and Dermagraft and Adaptic, and secondary dressing with gauze and tape.
Dermagraft placed per company protocol
|
Oasis
n=48 Participants
Study subjects who were randomized to treatment arm with Oasis. Oasis is a bio-absorbable ECM derived from porcine small intestinal submucosa. the product is processed using proprietary methods to retain its original structure while stored at room temperature.
The treatment included debridement, irrigation, primary dressing and Oasis and Adaptic, and secondary dressing with gauze and tape.
Oasis placed per company protocol
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
|
63.31 years
STANDARD_DEVIATION 9.09 • n=5 Participants
|
62.83 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
61.88 years
STANDARD_DEVIATION 8.64 • n=5 Participants
|
62.67 years
STANDARD_DEVIATION 9.01 • n=4 Participants
|
|
Sex: Female, Male
Analyzed participants · Female
|
2 Participants
n=5 Participants • Northern California veteran patient population
|
0 Participants
n=7 Participants • Northern California veteran patient population
|
1 Participants
n=5 Participants • Northern California veteran patient population
|
3 Participants
n=4 Participants • Northern California veteran patient population
|
|
Sex: Female, Male
Analyzed participants · Male
|
26 Participants
n=5 Participants • Northern California veteran patient population
|
42 Participants
n=7 Participants • Northern California veteran patient population
|
47 Participants
n=5 Participants • Northern California veteran patient population
|
115 Participants
n=4 Participants • Northern California veteran patient population
|
|
Ethnicity (NIH/OMB)
Analyzed participants · Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Analyzed participants · Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Analyzed participants · Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Analyzed participants · American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Analyzed participants · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Analyzed participants · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Analyzed participants · Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Analyzed participants · White
|
21 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Analyzed participants · More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Analyzed participants · Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
BMI
|
36.52 kg/m2
STANDARD_DEVIATION 6.59 • n=5 Participants
|
32.44 kg/m2
STANDARD_DEVIATION 5.32 • n=7 Participants
|
36.51 kg/m2
STANDARD_DEVIATION 11.55 • n=5 Participants
|
35.15 kg/m2
STANDARD_DEVIATION 7.83 • n=4 Participants
|
PRIMARY outcome
Timeframe: 15 weeksPopulation: Primary Outcome results consist of data available for the Northern California Veteran patient population participants who completed the study.
The primary outcome of interest is defined as the wound healed completely on or before visit 15, regardless of a later recurrence.
Outcome measures
| Measure |
Standard of Care
n=26 Participants
Consist of subjects who were randomized to treatment with standard of Care (SOC) which included debridement, irritation, primary dressing, Adaptic, secondary dressing gauze and tape without any grafts.
|
Dermagraft
n=35 Participants
Study subjects who were randomized to treatment arm with Dermagraft. Dermagraft is a cryopreserved human fibroblast-derived dermal substitute composed of viable newborn foreskin fibroblasts, seeded onto a bio-absorbable polyglactin mesh.
The treatment included debridement, irrigation, primary dressing and Dermagraft and Adaptic, and secondary dressing with gauze and tape.
Dermagraft placed per company protocol
|
Oasis
n=42 Participants
Study subjects who were randomized to treatment arm with Oasis. Oasis is a bio-absorbable ECM derived from porcine small intestinal submucosa. the product is processed using proprietary methods to retain its original structure while stored at room temperature.
The treatment included debridement, irrigation, primary dressing and Oasis and Adaptic, and secondary dressing with gauze and tape.
Oasis placed per company protocol
|
|---|---|---|---|
|
Wound Closure by Week 15
Not Healed
|
10 Participants
|
15 Participants
|
9 Participants
|
|
Wound Closure by Week 15
Healed completely
|
16 Participants
|
20 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: Primary Outcome results consist of data still available for the Veteran patient population participants who completed the study.
Complete wound closure at study endpoint. The Secondary outcome of interest is defined as the wound healed completely on or before visit 19, regardless of a later recurrence. The number of subjects analyzed at secondary outcome differs from primary outcome due to some subjects not completing the study.
Outcome measures
| Measure |
Standard of Care
n=23 Participants
Consist of subjects who were randomized to treatment with standard of Care (SOC) which included debridement, irritation, primary dressing, Adaptic, secondary dressing gauze and tape without any grafts.
|
Dermagraft
n=34 Participants
Study subjects who were randomized to treatment arm with Dermagraft. Dermagraft is a cryopreserved human fibroblast-derived dermal substitute composed of viable newborn foreskin fibroblasts, seeded onto a bio-absorbable polyglactin mesh.
The treatment included debridement, irrigation, primary dressing and Dermagraft and Adaptic, and secondary dressing with gauze and tape.
Dermagraft placed per company protocol
|
Oasis
n=39 Participants
Study subjects who were randomized to treatment arm with Oasis. Oasis is a bio-absorbable ECM derived from porcine small intestinal submucosa. the product is processed using proprietary methods to retain its original structure while stored at room temperature.
The treatment included debridement, irrigation, primary dressing and Oasis and Adaptic, and secondary dressing with gauze and tape.
Oasis placed per company protocol
|
|---|---|---|---|
|
Wound Closure at 20 Weeks
Not healed
|
5 Wound Closure in weeks
|
9 Wound Closure in weeks
|
12 Wound Closure in weeks
|
|
Wound Closure at 20 Weeks
Healed completely
|
18 Wound Closure in weeks
|
25 Wound Closure in weeks
|
27 Wound Closure in weeks
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data not available because the investigators did not asses the cost effectiveness for the study.
Outcome measures
Outcome data not reported
Adverse Events
Standard of Care
Serious events: 6 serious events
Other events: 3 other events
Deaths: 5 deaths
Dermagraft
Serious events: 15 serious events
Other events: 4 other events
Deaths: 6 deaths
Oasis
Serious events: 16 serious events
Other events: 2 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Standard of Care
n=28 participants at risk
Consist of subjects who were randomized to treatment with standard of Care (SOC) which included debridement, irritation, primary dressing, Adaptic, secondary dressing gauze and tape.
|
Dermagraft
n=42 participants at risk
Study subjects who were randomized to treatment arm with Dermagraft. Dermagraft is a cryopreserved human fibroblast-derived dermal substitute composed of viable newborn foreskin fibroblasts, seeded onto a bio-absorbable polyglactin mesh.
The treatment included debridement, irrigation, primary dressing and Dermagraft and Adaptic, and secondary dressing with gauze and tape.
Dermagraft placed per company protocol
|
Oasis
n=48 participants at risk
Study subjects who were randomized to treatment arm with Oasis. Oasis is a bio-absorbable ECM derived from porcine small intestinal submucosa. the product is processed using proprietary methods to retain its original structure while stored at room temperature.
The treatment included debridement, irrigation, primary dressing and Oasis and Adaptic, and secondary dressing with gauze and tape.
Oasis placed per company protocol
|
|---|---|---|---|
|
Infections and infestations
Non-study related
|
21.4%
6/28 • Number of events 6 • Visits 1-2: consent and screen the subject. Obtain medical history, vitals, concomitant medications, and adverse events recorded. Visit 3: If after two weeks, the subject qualifies to continue, the subject is randomized into one of three groups. Visits 4-15: Subjects follow up weekly for study visit which includes wounds undressed, assessed, cleaned and debrided, traced, photographed, and redressed again. Visit 16-19: These are the follow-up visits. There will be 4 visits spread over 16 weeks.
Adverse events were collected through the patient and/or through patient chart review.
|
31.0%
13/42 • Number of events 13 • Visits 1-2: consent and screen the subject. Obtain medical history, vitals, concomitant medications, and adverse events recorded. Visit 3: If after two weeks, the subject qualifies to continue, the subject is randomized into one of three groups. Visits 4-15: Subjects follow up weekly for study visit which includes wounds undressed, assessed, cleaned and debrided, traced, photographed, and redressed again. Visit 16-19: These are the follow-up visits. There will be 4 visits spread over 16 weeks.
Adverse events were collected through the patient and/or through patient chart review.
|
33.3%
16/48 • Number of events 16 • Visits 1-2: consent and screen the subject. Obtain medical history, vitals, concomitant medications, and adverse events recorded. Visit 3: If after two weeks, the subject qualifies to continue, the subject is randomized into one of three groups. Visits 4-15: Subjects follow up weekly for study visit which includes wounds undressed, assessed, cleaned and debrided, traced, photographed, and redressed again. Visit 16-19: These are the follow-up visits. There will be 4 visits spread over 16 weeks.
Adverse events were collected through the patient and/or through patient chart review.
|
|
Infections and infestations
Involved study related foot ulcer
|
0.00%
0/28 • Visits 1-2: consent and screen the subject. Obtain medical history, vitals, concomitant medications, and adverse events recorded. Visit 3: If after two weeks, the subject qualifies to continue, the subject is randomized into one of three groups. Visits 4-15: Subjects follow up weekly for study visit which includes wounds undressed, assessed, cleaned and debrided, traced, photographed, and redressed again. Visit 16-19: These are the follow-up visits. There will be 4 visits spread over 16 weeks.
Adverse events were collected through the patient and/or through patient chart review.
|
4.8%
2/42 • Number of events 2 • Visits 1-2: consent and screen the subject. Obtain medical history, vitals, concomitant medications, and adverse events recorded. Visit 3: If after two weeks, the subject qualifies to continue, the subject is randomized into one of three groups. Visits 4-15: Subjects follow up weekly for study visit which includes wounds undressed, assessed, cleaned and debrided, traced, photographed, and redressed again. Visit 16-19: These are the follow-up visits. There will be 4 visits spread over 16 weeks.
Adverse events were collected through the patient and/or through patient chart review.
|
0.00%
0/48 • Visits 1-2: consent and screen the subject. Obtain medical history, vitals, concomitant medications, and adverse events recorded. Visit 3: If after two weeks, the subject qualifies to continue, the subject is randomized into one of three groups. Visits 4-15: Subjects follow up weekly for study visit which includes wounds undressed, assessed, cleaned and debrided, traced, photographed, and redressed again. Visit 16-19: These are the follow-up visits. There will be 4 visits spread over 16 weeks.
Adverse events were collected through the patient and/or through patient chart review.
|
Other adverse events
| Measure |
Standard of Care
n=28 participants at risk
Consist of subjects who were randomized to treatment with standard of Care (SOC) which included debridement, irritation, primary dressing, Adaptic, secondary dressing gauze and tape.
|
Dermagraft
n=42 participants at risk
Study subjects who were randomized to treatment arm with Dermagraft. Dermagraft is a cryopreserved human fibroblast-derived dermal substitute composed of viable newborn foreskin fibroblasts, seeded onto a bio-absorbable polyglactin mesh.
The treatment included debridement, irrigation, primary dressing and Dermagraft and Adaptic, and secondary dressing with gauze and tape.
Dermagraft placed per company protocol
|
Oasis
n=48 participants at risk
Study subjects who were randomized to treatment arm with Oasis. Oasis is a bio-absorbable ECM derived from porcine small intestinal submucosa. the product is processed using proprietary methods to retain its original structure while stored at room temperature.
The treatment included debridement, irrigation, primary dressing and Oasis and Adaptic, and secondary dressing with gauze and tape.
Oasis placed per company protocol
|
|---|---|---|---|
|
Cardiac disorders
Non-study related
|
10.7%
3/28 • Number of events 3 • Visits 1-2: consent and screen the subject. Obtain medical history, vitals, concomitant medications, and adverse events recorded. Visit 3: If after two weeks, the subject qualifies to continue, the subject is randomized into one of three groups. Visits 4-15: Subjects follow up weekly for study visit which includes wounds undressed, assessed, cleaned and debrided, traced, photographed, and redressed again. Visit 16-19: These are the follow-up visits. There will be 4 visits spread over 16 weeks.
Adverse events were collected through the patient and/or through patient chart review.
|
9.5%
4/42 • Number of events 4 • Visits 1-2: consent and screen the subject. Obtain medical history, vitals, concomitant medications, and adverse events recorded. Visit 3: If after two weeks, the subject qualifies to continue, the subject is randomized into one of three groups. Visits 4-15: Subjects follow up weekly for study visit which includes wounds undressed, assessed, cleaned and debrided, traced, photographed, and redressed again. Visit 16-19: These are the follow-up visits. There will be 4 visits spread over 16 weeks.
Adverse events were collected through the patient and/or through patient chart review.
|
4.2%
2/48 • Number of events 2 • Visits 1-2: consent and screen the subject. Obtain medical history, vitals, concomitant medications, and adverse events recorded. Visit 3: If after two weeks, the subject qualifies to continue, the subject is randomized into one of three groups. Visits 4-15: Subjects follow up weekly for study visit which includes wounds undressed, assessed, cleaned and debrided, traced, photographed, and redressed again. Visit 16-19: These are the follow-up visits. There will be 4 visits spread over 16 weeks.
Adverse events were collected through the patient and/or through patient chart review.
|
Additional Information
Sara Dahle, D.P.M., M.P.H.
VA Northern California Health Care System
Phone: 916-843-7151
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place