Trial Outcomes & Findings for Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (NCT NCT04918784)
NCT ID: NCT04918784
Last Updated: 2023-09-28
Results Overview
Primary outcome is number of participants with 100% epithelialization at 12 weeks of treatment as determined by investigator assessment of the ulcer and imaging.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-09-28
Participant Flow
There is a 2 week run-in period to confirm eligibility prior to treatment on study
Participant milestones
| Measure |
Treatment With Synthetic Hybrid-Scale Fiber Matrix
Diabetic foot ulcers will be treated by application of the Synthetic Hybrid-Scale Fiber Matrix. The synthetic matrix will be applied weekly or as needed based on the clinician discretion and ongoing wound assessment.
Restrata®: Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides a moist environment for the body's natural healing process to occur. Restrata® is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix.
|
Treatment With Standard of Care
Diabetic foot ulcers will be treated by application of an appropriate dressing (foam or alginate dressing) to maintain wound moisture balance in the wound and changed daily.
Wound Dressing: Alginate or Foam wound dressing is intended to manage wounds.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
21
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Treatment With Synthetic Hybrid-Scale Fiber Matrix
Diabetic foot ulcers will be treated by application of the Synthetic Hybrid-Scale Fiber Matrix. The synthetic matrix will be applied weekly or as needed based on the clinician discretion and ongoing wound assessment.
Restrata®: Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides a moist environment for the body's natural healing process to occur. Restrata® is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix.
|
Treatment With Standard of Care
Diabetic foot ulcers will be treated by application of an appropriate dressing (foam or alginate dressing) to maintain wound moisture balance in the wound and changed daily.
Wound Dressing: Alginate or Foam wound dressing is intended to manage wounds.
|
|---|---|---|
|
Overall Study
Amputation - no longer eligible
|
1
|
2
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
patient non-compliance
|
3
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers
Baseline characteristics by cohort
| Measure |
Treatment With Synthetic Hybrid-Scale Fiber Matrix
n=25 Participants
Diabetic foot ulcers will be treated by application of the Synthetic Hybrid-Scale Fiber Matrix. The synthetic matrix will be applied weekly or as needed based on the clinician discretion and ongoing wound assessment.
Restrata®: Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides a moist environment for the body's natural healing process to occur. Restrata® is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix.
|
Treatment With Standard of Care
n=21 Participants
Diabetic foot ulcers will be treated by application of an appropriate dressing (foam or alginate dressing) to maintain wound moisture balance in the wound and changed daily.
Wound Dressing: Alginate or Foam wound dressing is intended to manage wounds.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Patients who completed 12 weeks of treatment
Primary outcome is number of participants with 100% epithelialization at 12 weeks of treatment as determined by investigator assessment of the ulcer and imaging.
Outcome measures
| Measure |
Treatment With Synthetic Hybrid-Scale Fiber Matrix
n=19 Participants
Diabetic foot ulcers will be treated by application of the Synthetic Hybrid-Scale Fiber Matrix. The synthetic matrix will be applied weekly or as needed based on the clinician discretion and ongoing wound assessment.
Restrata®: Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides a moist environment for the body's natural healing process to occur. Restrata® is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix.
|
Treatment With Standard of Care
n=18 Participants
Diabetic foot ulcers will be treated by application of an appropriate dressing (foam or alginate dressing) to maintain wound moisture balance in the wound and changed daily.
Wound Dressing: Alginate or Foam wound dressing is intended to manage wounds.
|
|---|---|---|
|
Number of Participants With 100% Re-epithelialization
|
14 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Per protocol population including participants that completed the primary study endpoint/treatment period without withdrawal.
The difference in wound area from baseline to 100% re-epithelialization or week 12 will be summarized for each treatment group in each arm. Wound sizes were documented by the investigator at baseline to end of the treatment period for each participant.
Outcome measures
| Measure |
Treatment With Synthetic Hybrid-Scale Fiber Matrix
n=19 Participants
Diabetic foot ulcers will be treated by application of the Synthetic Hybrid-Scale Fiber Matrix. The synthetic matrix will be applied weekly or as needed based on the clinician discretion and ongoing wound assessment.
Restrata®: Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides a moist environment for the body's natural healing process to occur. Restrata® is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix.
|
Treatment With Standard of Care
n=18 Participants
Diabetic foot ulcers will be treated by application of an appropriate dressing (foam or alginate dressing) to maintain wound moisture balance in the wound and changed daily.
Wound Dressing: Alginate or Foam wound dressing is intended to manage wounds.
|
|---|---|---|
|
Change in Wound Area
|
89.3 Percentage of ulcer size decrease
Standard Deviation 20.8
|
62.9 Percentage of ulcer size decrease
Standard Deviation 56.0
|
SECONDARY outcome
Timeframe: Up to 12 WeeksPopulation: Per protocol population who completed the primary endpoint/treatment period without withdrawal
The number of weeks from initial application of study treatment until complete re-epithelialization is first identified.
Outcome measures
| Measure |
Treatment With Synthetic Hybrid-Scale Fiber Matrix
n=19 Participants
Diabetic foot ulcers will be treated by application of the Synthetic Hybrid-Scale Fiber Matrix. The synthetic matrix will be applied weekly or as needed based on the clinician discretion and ongoing wound assessment.
Restrata®: Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides a moist environment for the body's natural healing process to occur. Restrata® is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix.
|
Treatment With Standard of Care
n=18 Participants
Diabetic foot ulcers will be treated by application of an appropriate dressing (foam or alginate dressing) to maintain wound moisture balance in the wound and changed daily.
Wound Dressing: Alginate or Foam wound dressing is intended to manage wounds.
|
|---|---|---|
|
Time to Wound Closure
|
6.57 Number of weeks
Standard Deviation 3.0
|
7.0 Number of weeks
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The per protocol population, which includes all patients that completed the primary endpoint/treatment period without withdrawal
The number of study treatment applications including the initial application until 12 weeks or until complete re-epithelialization, whichever occurs first.
Outcome measures
| Measure |
Treatment With Synthetic Hybrid-Scale Fiber Matrix
n=19 Participants
Diabetic foot ulcers will be treated by application of the Synthetic Hybrid-Scale Fiber Matrix. The synthetic matrix will be applied weekly or as needed based on the clinician discretion and ongoing wound assessment.
Restrata®: Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides a moist environment for the body's natural healing process to occur. Restrata® is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix.
|
Treatment With Standard of Care
n=18 Participants
Diabetic foot ulcers will be treated by application of an appropriate dressing (foam or alginate dressing) to maintain wound moisture balance in the wound and changed daily.
Wound Dressing: Alginate or Foam wound dressing is intended to manage wounds.
|
|---|---|---|
|
Number of Treatment Applications
|
6.8 Average number of treatment applications
Standard Deviation 3.5
|
7.7 Average number of treatment applications
Standard Deviation 3.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksThe survey will be completed at the day of initial application and at either 12 weeks or at complete re-epithelialization
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksCost data from the patient's treatment will be analyzed based on diagnoses, procedure and supply codes to determine cost efficacy and outcomes with the treatment pathway and related technology utilized during the course of care.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
Adverse Events
Treatment With Synthetic Hybrid-Scale Fiber Matrix
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Treatment With Standard of Care
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment With Synthetic Hybrid-Scale Fiber Matrix
n=25 participants at risk
Diabetic foot ulcers will be treated by application of the Synthetic Hybrid-Scale Fiber Matrix. The synthetic matrix will be applied weekly or as needed based on the clinician discretion and ongoing wound assessment.
Restrata®: Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides a moist environment for the body's natural healing process to occur. Restrata® is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix.
|
Treatment With Standard of Care
n=21 participants at risk
Diabetic foot ulcers will be treated by application of an appropriate dressing (foam or alginate dressing) to maintain wound moisture balance in the wound and changed daily.
Wound Dressing: Alginate or Foam wound dressing is intended to manage wounds.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Amputation
|
4.0%
1/25 • Number of events 1 • For each individual patient, data was collected over the 12 week treatment period or until complete re-epithelialization and 2 week follow up visit, up to a maximum of 14 weeks
Adverse events were monitored starting at randomization and through the treatment period and 2 week follow up. Adverse events were not monitored during the 2 week run-in period
|
9.5%
2/21 • Number of events 2 • For each individual patient, data was collected over the 12 week treatment period or until complete re-epithelialization and 2 week follow up visit, up to a maximum of 14 weeks
Adverse events were monitored starting at randomization and through the treatment period and 2 week follow up. Adverse events were not monitored during the 2 week run-in period
|
|
Cardiac disorders
Cerebral vascular accident
|
4.0%
1/25 • Number of events 1 • For each individual patient, data was collected over the 12 week treatment period or until complete re-epithelialization and 2 week follow up visit, up to a maximum of 14 weeks
Adverse events were monitored starting at randomization and through the treatment period and 2 week follow up. Adverse events were not monitored during the 2 week run-in period
|
0.00%
0/21 • For each individual patient, data was collected over the 12 week treatment period or until complete re-epithelialization and 2 week follow up visit, up to a maximum of 14 weeks
Adverse events were monitored starting at randomization and through the treatment period and 2 week follow up. Adverse events were not monitored during the 2 week run-in period
|
Other adverse events
| Measure |
Treatment With Synthetic Hybrid-Scale Fiber Matrix
n=25 participants at risk
Diabetic foot ulcers will be treated by application of the Synthetic Hybrid-Scale Fiber Matrix. The synthetic matrix will be applied weekly or as needed based on the clinician discretion and ongoing wound assessment.
Restrata®: Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides a moist environment for the body's natural healing process to occur. Restrata® is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix.
|
Treatment With Standard of Care
n=21 participants at risk
Diabetic foot ulcers will be treated by application of an appropriate dressing (foam or alginate dressing) to maintain wound moisture balance in the wound and changed daily.
Wound Dressing: Alginate or Foam wound dressing is intended to manage wounds.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Infection
|
24.0%
6/25 • Number of events 25 • For each individual patient, data was collected over the 12 week treatment period or until complete re-epithelialization and 2 week follow up visit, up to a maximum of 14 weeks
Adverse events were monitored starting at randomization and through the treatment period and 2 week follow up. Adverse events were not monitored during the 2 week run-in period
|
9.5%
2/21 • Number of events 21 • For each individual patient, data was collected over the 12 week treatment period or until complete re-epithelialization and 2 week follow up visit, up to a maximum of 14 weeks
Adverse events were monitored starting at randomization and through the treatment period and 2 week follow up. Adverse events were not monitored during the 2 week run-in period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60