Trial Outcomes & Findings for Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU) (NCT NCT04927702)
NCT ID: NCT04927702
Last Updated: 2026-02-27
Results Overview
The number of wounds in each treatment arm that achieved 100 percent epithelialization of wound as assessed by a blinded evaluator via review of a three-dimensional high resolution photo of the wound plus confirmation of no drainage or need for additional dressing 2 weeks after 100 percent epithelialization
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
12 weeks
Results posted on
2026-02-27
Participant Flow
Unit of analysis: Wounds
Participant milestones
| Measure |
Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
|
Diabetic Foot Ulcer Participants Assigned to Standard of Care
Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Standard of Care: To ensure off-loading, each patient will be fitted with an off-loading device based on the investigator's decision, e.g. a boot for forefoot and a heel protector for hindfoot. Patients is instructed on how to care for the surgical site, utilize an off-loading device, and keep the surgical site moist and clean. If the wound is dry, a hydrogel category dressing type should be used. If the wound has exudate, an alginate or foam dressing is recommended.
|
Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
|
Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Living Cellular Skin Substitute: An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8 9
|
10 10
|
14 15
|
16 19
|
|
Overall Study
COMPLETED
|
2 2
|
6 6
|
11 12
|
13 16
|
|
Overall Study
NOT COMPLETED
|
6 7
|
4 4
|
3 3
|
3 3
|
Reasons for withdrawal
| Measure |
Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
|
Diabetic Foot Ulcer Participants Assigned to Standard of Care
Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Standard of Care: To ensure off-loading, each patient will be fitted with an off-loading device based on the investigator's decision, e.g. a boot for forefoot and a heel protector for hindfoot. Patients is instructed on how to care for the surgical site, utilize an off-loading device, and keep the surgical site moist and clean. If the wound is dry, a hydrogel category dressing type should be used. If the wound has exudate, an alginate or foam dressing is recommended.
|
Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
|
Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Living Cellular Skin Substitute: An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.
|
|---|---|---|---|---|
|
Overall Study
Study closure
|
5
|
4
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)
Baseline characteristics by cohort
| Measure |
Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
n=8 Participants
Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
|
Diabetic Foot Ulcer Participants Assigned to Standard of Care
n=10 Participants
Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Standard of Care: To ensure off-loading, each patient will be fitted with an off-loading device based on the investigator's decision, e.g. a boot for forefoot and a heel protector for hindfoot. Patients is instructed on how to care for the surgical site, utilize an off-loading device, and keep the surgical site moist and clean. If the wound is dry, a hydrogel category dressing type should be used. If the wound has exudate, an alginate or foam dressing is recommended.
|
Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
n=14 Participants
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
|
Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)
n=16 Participants
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Living Cellular Skin Substitute: An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 12.6 • n=24 Participants
|
53 years
STANDARD_DEVIATION 14.5 • n=20 Participants
|
59 years
STANDARD_DEVIATION 10.4 • n=40 Participants
|
73 years
STANDARD_DEVIATION 12.2 • n=565 Participants
|
64 years
STANDARD_DEVIATION 14.7 • n=349 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=24 Participants
|
3 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
9 Participants
n=565 Participants
|
21 Participants
n=349 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=24 Participants
|
7 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
7 Participants
n=565 Participants
|
27 Participants
n=349 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=24 Participants
|
3 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
7 Participants
n=565 Participants
|
12 Participants
n=349 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=24 Participants
|
7 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
9 Participants
n=565 Participants
|
36 Participants
n=349 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
1 Participants
n=349 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=24 Participants
|
3 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=565 Participants
|
7 Participants
n=349 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=24 Participants
|
7 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
14 Participants
n=565 Participants
|
40 Participants
n=349 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
|
Wound area at baseline in cm^2
|
3.0 cm^2
STANDARD_DEVIATION 1.2 • n=24 Participants
|
5.0 cm^2
STANDARD_DEVIATION 4.4 • n=20 Participants
|
17.7 cm^2
STANDARD_DEVIATION 13.9 • n=40 Participants
|
14.4 cm^2
STANDARD_DEVIATION 12.2 • n=565 Participants
|
11.6 cm^2
STANDARD_DEVIATION 12.1 • n=349 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe number of wounds in each treatment arm that achieved 100 percent epithelialization of wound as assessed by a blinded evaluator via review of a three-dimensional high resolution photo of the wound plus confirmation of no drainage or need for additional dressing 2 weeks after 100 percent epithelialization
Outcome measures
| Measure |
Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
n=2 wounds
Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
|
Diabetic Foot Ulcer Participants Assigned to Standard of Care
n=6 wounds
Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Standard of Care: To ensure off-loading, each patient will be fitted with an off-loading device based on the investigator's decision, e.g. a boot for forefoot and a heel protector for hindfoot. Patients is instructed on how to care for the surgical site, utilize an off-loading device, and keep the surgical site moist and clean. If the wound is dry, a hydrogel category dressing type should be used. If the wound has exudate, an alginate or foam dressing is recommended.
|
Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
|
Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Living Cellular Skin Substitute: An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.
|
|---|---|---|---|---|
|
For Diabetic Foot Ulcers, Number of Wounds With 100 Percent Epithelialization (Closure) of Wound
|
2 wounds
|
1 wounds
|
—
|
—
|
PRIMARY outcome
Timeframe: 16 weeksThe number of wounds in each treatment arm with 100 percent epithelialization of wound as assessed by a blinded evaluator via review of a three-dimensional high resolution photo of the wound plus confirmation of no drainage or need for additional dressing 2 weeks after 100 percent epithelialization
Outcome measures
| Measure |
Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
n=12 wounds
Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
|
Diabetic Foot Ulcer Participants Assigned to Standard of Care
n=16 wounds
Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Standard of Care: To ensure off-loading, each patient will be fitted with an off-loading device based on the investigator's decision, e.g. a boot for forefoot and a heel protector for hindfoot. Patients is instructed on how to care for the surgical site, utilize an off-loading device, and keep the surgical site moist and clean. If the wound is dry, a hydrogel category dressing type should be used. If the wound has exudate, an alginate or foam dressing is recommended.
|
Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
|
Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Living Cellular Skin Substitute: An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.
|
|---|---|---|---|---|
|
For Venous Leg Ulcers, Number of Wounds With 100 Percent Epithelialization (Closure) of Wound
|
1 wounds
|
4 wounds
|
—
|
—
|
SECONDARY outcome
Timeframe: Weekly assessments for 12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first.Population: Positive numbers represent increases and negative numbers to represent decreases
Wound area measurements will be made via a three-dimensional high resolution photo of the wound with automated measurements. Mean percent wound change will be calculated for each treatment arm/group with Week 1 as the baseline value. Change is calculated using the 2-week follow up visit after wound closure for wounds that achieved closure, or for wounds that did not achieve closure, the Week 12 wound area for DFUs and Week 16 wound area for VLUs.
Outcome measures
| Measure |
Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
n=2 wounds
Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
|
Diabetic Foot Ulcer Participants Assigned to Standard of Care
n=6 wounds
Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Standard of Care: To ensure off-loading, each patient will be fitted with an off-loading device based on the investigator's decision, e.g. a boot for forefoot and a heel protector for hindfoot. Patients is instructed on how to care for the surgical site, utilize an off-loading device, and keep the surgical site moist and clean. If the wound is dry, a hydrogel category dressing type should be used. If the wound has exudate, an alginate or foam dressing is recommended.
|
Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
n=12 wounds
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
|
Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)
n=16 wounds
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Living Cellular Skin Substitute: An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.
|
|---|---|---|---|---|
|
Percentage Change in Wound Area
|
-100 Percentage change
Standard Deviation 0
|
-64.9 Percentage change
Standard Deviation 53.2
|
-14.2 Percentage change
Standard Deviation 77.4
|
-52.7 Percentage change
Standard Deviation 48.8
|
SECONDARY outcome
Timeframe: 12 weeks for DFU wounds (16 weeks for VLU wounds), or until 100 percent epithelialization, whichever occurs first.The number of weeks from initial application of study product until 100 percent epithelialization is first identified.
Outcome measures
| Measure |
Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
n=1 Wounds
Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
|
Diabetic Foot Ulcer Participants Assigned to Standard of Care
n=4 Wounds
Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Standard of Care: To ensure off-loading, each patient will be fitted with an off-loading device based on the investigator's decision, e.g. a boot for forefoot and a heel protector for hindfoot. Patients is instructed on how to care for the surgical site, utilize an off-loading device, and keep the surgical site moist and clean. If the wound is dry, a hydrogel category dressing type should be used. If the wound has exudate, an alginate or foam dressing is recommended.
|
Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
n=1 Wounds
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
|
Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)
n=2 Wounds
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Living Cellular Skin Substitute: An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.
|
|---|---|---|---|---|
|
Time to 100 Percent Epithelialization
|
6 Weeks
Standard Deviation 0
|
10.8 Weeks
Standard Deviation 3.6
|
6 Weeks
Standard Deviation 0
|
9.5 Weeks
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Initial application until 12 weeks for DFU patients and 16 weeks for VLU patients, or until 100% re-epithelialization, whichever occurs firstPopulation: ITT population
The number of study applications including the initial application until 12 weeks for DFU patients and 16 weeks for VLU patients, or until 100% re-epithelialization, whichever occurs first
Outcome measures
| Measure |
Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
n=15 Wounds
Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
|
Diabetic Foot Ulcer Participants Assigned to Standard of Care
n=19 Wounds
Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Standard of Care: To ensure off-loading, each patient will be fitted with an off-loading device based on the investigator's decision, e.g. a boot for forefoot and a heel protector for hindfoot. Patients is instructed on how to care for the surgical site, utilize an off-loading device, and keep the surgical site moist and clean. If the wound is dry, a hydrogel category dressing type should be used. If the wound has exudate, an alginate or foam dressing is recommended.
|
Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
n=10 Wounds
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
|
Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)
n=9 Wounds
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Living Cellular Skin Substitute: An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.
|
|---|---|---|---|---|
|
Total Number of Product Applications
|
7.7 Number of applications
Standard Deviation 2.8
|
7.1 Number of applications
Standard Deviation 2.3
|
8.9 Number of applications
Standard Deviation 4.0
|
4.1 Number of applications
Standard Deviation 1.5
|
Adverse Events
Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Diabetic Foot Ulcer Participants Assigned to Standard of Care
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
n=8 participants at risk
Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
|
Diabetic Foot Ulcer Participants Assigned to Standard of Care
n=10 participants at risk
Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Standard of Care: To ensure off-loading, each patient will be fitted with an off-loading device based on the investigator's decision, e.g. a boot for forefoot and a heel protector for hindfoot. Patients is instructed on how to care for the surgical site, utilize an off-loading device, and keep the surgical site moist and clean. If the wound is dry, a hydrogel category dressing type should be used. If the wound has exudate, an alginate or foam dressing is recommended.
|
Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
n=14 participants at risk
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
|
Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)
n=16 participants at risk
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Living Cellular Skin Substitute: An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.
|
|---|---|---|---|---|
|
Infections and infestations
Amputation
|
0.00%
0/8 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
10.0%
1/10 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/14 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/16 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
Investigations
Atherectomy
|
0.00%
0/8 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
10.0%
1/10 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/14 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/16 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
Skin and subcutaneous tissue disorders
Pain near wound
|
0.00%
0/8 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
10.0%
1/10 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/14 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/16 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/8 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/10 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
7.1%
1/14 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/16 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
Other adverse events
| Measure |
Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
n=8 participants at risk
Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
|
Diabetic Foot Ulcer Participants Assigned to Standard of Care
n=10 participants at risk
Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Standard of Care: To ensure off-loading, each patient will be fitted with an off-loading device based on the investigator's decision, e.g. a boot for forefoot and a heel protector for hindfoot. Patients is instructed on how to care for the surgical site, utilize an off-loading device, and keep the surgical site moist and clean. If the wound is dry, a hydrogel category dressing type should be used. If the wound has exudate, an alginate or foam dressing is recommended.
|
Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)
n=14 participants at risk
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Synthetic Hybrid-Scale Fiber Matrix: A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
|
Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)
n=16 participants at risk
Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Living Cellular Skin Substitute: An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.
|
|---|---|---|---|---|
|
Infections and infestations
Covid-19
|
0.00%
0/8 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/10 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
7.1%
1/14 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/16 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
Injury, poisoning and procedural complications
Wound erythema
|
0.00%
0/8 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/10 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
7.1%
1/14 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/16 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
Infections and infestations
Wound Infection
|
0.00%
0/8 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/10 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
7.1%
1/14 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/16 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/10 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
7.1%
1/14 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/16 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
Cardiac disorders
Cardiac Murmur
|
0.00%
0/8 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/10 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
7.1%
1/14 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/16 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
Infections and infestations
Pseudomonal infections
|
0.00%
0/8 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/10 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
7.1%
1/14 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/16 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/8 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/10 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
7.1%
1/14 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/16 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
Surgical and medical procedures
Radiofrequency ablation
|
0.00%
0/8 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/10 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
7.1%
1/14 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/16 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
Injury, poisoning and procedural complications
Wound NOS
|
0.00%
0/8 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/10 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/14 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
6.2%
1/16 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/8 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/10 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
7.1%
1/14 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
6.2%
1/16 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
Infections and infestations
Infestation
|
0.00%
0/8 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/10 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/14 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
6.2%
1/16 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
Skin and subcutaneous tissue disorders
skin ulcer
|
0.00%
0/8 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
10.0%
1/10 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
7.1%
1/14 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
6.2%
1/16 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
General disorders
influenza like illness
|
0.00%
0/8 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/10 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
7.1%
1/14 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/16 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract signs and symptoms
|
0.00%
0/8 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/10 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
7.1%
1/14 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/16 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
Skin and subcutaneous tissue disorders
Blister
|
12.5%
1/8 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/10 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/14 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/16 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
Vascular disorders
Arteriovenous fistula
|
12.5%
1/8 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/10 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/14 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/16 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
Skin and subcutaneous tissue disorders
Facial skin infection
|
12.5%
1/8 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/10 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/14 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/16 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
Skin and subcutaneous tissue disorders
Skin lesion excision
|
12.5%
1/8 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/10 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/14 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/16 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
General disorders
Headache
|
0.00%
0/8 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
10.0%
1/10 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/14 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/16 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/8 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
10.0%
1/10 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/14 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/16 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
|
Injury, poisoning and procedural complications
limb injury
|
0.00%
0/8 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
10.0%
1/10 • Number of events 1 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/14 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
0.00%
0/16 • 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60