Trial Outcomes & Findings for Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy System (tNPWT) (NCT NCT02470806)
NCT ID: NCT02470806
Last Updated: 2020-04-06
Results Overview
Ulcer area was photographed in order to determine the measurements of the post-debridement ulcer area (cm\^2 and total percentage \[%\]) using the ARANZ Silhouette wound imaging and measurement device.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
164 participants
Primary outcome timeframe
Baseline through 12 weeks
Results posted on
2020-04-06
Participant Flow
Participant milestones
| Measure |
PICO System
Subjects randomized to receive the PICO system applied to the target ulcer area over the 12-week treatment period from Baseline.
|
tNPWT System
Subjects randomized to receive the tNPWT system applied to the target ulcer area over the 12-week treatment period from Baseline.
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
84
|
|
Overall Study
COMPLETED
|
62
|
42
|
|
Overall Study
NOT COMPLETED
|
18
|
42
|
Reasons for withdrawal
| Measure |
PICO System
Subjects randomized to receive the PICO system applied to the target ulcer area over the 12-week treatment period from Baseline.
|
tNPWT System
Subjects randomized to receive the tNPWT system applied to the target ulcer area over the 12-week treatment period from Baseline.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Adverse Event
|
5
|
2
|
|
Overall Study
Protocol Violation
|
4
|
11
|
|
Overall Study
Physician Decision
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
10
|
|
Overall Study
Lack of Efficacy
|
5
|
15
|
Baseline Characteristics
Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy System (tNPWT)
Baseline characteristics by cohort
| Measure |
PICO System
n=80 Participants
Subjects randomized to receive the PICO system applied to the target ulcer area over the 12-week treatment period from Baseline.
|
tNPWT System
n=81 Participants
Subjects randomized to receive the tNPWT system applied to the target ulcer area over the 12-week treatment period from Baseline.
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
61.5 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
77 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
67 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
78 participants
n=5 Participants
|
76 participants
n=7 Participants
|
154 participants
n=5 Participants
|
|
BMI (kg/m^2)
|
33.7 kg/m^2
STANDARD_DEVIATION 8.8 • n=5 Participants
|
33.9 kg/m^2
STANDARD_DEVIATION 9.0 • n=7 Participants
|
33.8 kg/m^2
STANDARD_DEVIATION 8.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through 12 weeksPopulation: The Per-Protocol (PP) population was used to analyze outcome measure data and included all subjects who were randomized, met inclusion/exclusion criteria, had not discontinued treatment within the first 9 weeks (-1 day), and had no significant protocol deviations.
Ulcer area was photographed in order to determine the measurements of the post-debridement ulcer area (cm\^2 and total percentage \[%\]) using the ARANZ Silhouette wound imaging and measurement device.
Outcome measures
| Measure |
PICO System
n=64 Participants
Subjects randomized to receive the PICO system applied to the target ulcer area over the 12-week treatment period from Baseline.
|
tNPWT System
n=51 Participants
Subjects randomized to receive the tNPWT system applied to the target ulcer area over the 12-week treatment period from Baseline.
|
|---|---|---|
|
Change in Ulcer Area From Baseline to the End of the Treatment Period
Baseline wound area
|
6.2 cm^2
Standard Deviation 5.9
|
7.8 cm^2
Standard Deviation 6.3
|
|
Change in Ulcer Area From Baseline to the End of the Treatment Period
Final wound area
|
0.7 cm^2
Standard Deviation 1.8
|
3.8 cm^2
Standard Deviation 6.7
|
|
Change in Ulcer Area From Baseline to the End of the Treatment Period
Change in wound area
|
-5.5 cm^2
Standard Deviation 5.4
|
-4.0 cm^2
Standard Deviation 6.2
|
PRIMARY outcome
Timeframe: Baseline through 12 weeksPopulation: The Per-Protocol (PP) population was used to analyze outcome measure data and included all subjects who were randomized, met inclusion/exclusion criteria, had not discontinued treatment within the first 9 weeks (-1 day), and had no significant protocol deviations.
Ulcer area was photographed in order to determine the measurements of the postdebridement ulcer area (cm\^2 and total percentage \[%\]) using the ARANZ Silhouette wound imaging and measurement device.
Outcome measures
| Measure |
PICO System
n=64 Participants
Subjects randomized to receive the PICO system applied to the target ulcer area over the 12-week treatment period from Baseline.
|
tNPWT System
n=51 Participants
Subjects randomized to receive the tNPWT system applied to the target ulcer area over the 12-week treatment period from Baseline.
|
|---|---|---|
|
Percentage Change in Ulcer Area From Baseline to the End of the Treatment Period
|
-88.7 Percentage of change in wound area
Standard Deviation 24.1
|
-58.6 Percentage of change in wound area
Standard Deviation 63.5
|
SECONDARY outcome
Timeframe: Baseline through 12 weeksPopulation: Change in wound depth over 12-week treatment period by treatment group (PP population - all wounds)
Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm\^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device.
Outcome measures
| Measure |
PICO System
n=64 Participants
Subjects randomized to receive the PICO system applied to the target ulcer area over the 12-week treatment period from Baseline.
|
tNPWT System
n=51 Participants
Subjects randomized to receive the tNPWT system applied to the target ulcer area over the 12-week treatment period from Baseline.
|
|---|---|---|
|
Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Baseline wound depth
|
4.0 mm
Standard Deviation 6.8
|
2.4 mm
Standard Deviation 1.3
|
|
Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Final wound depth
|
0.6 mm
Standard Deviation 1.1
|
1.5 mm
Standard Deviation 2.1
|
|
Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Change in wound depth
|
-3.4 mm
Standard Deviation 7.1
|
-0.9 mm
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline through 12 weeksPopulation: Change in wound volume over 12-week treatment period by treatment group (PP population - all wounds)
Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm\^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device.
Outcome measures
| Measure |
PICO System
n=64 Participants
Subjects randomized to receive the PICO system applied to the target ulcer area over the 12-week treatment period from Baseline.
|
tNPWT System
n=51 Participants
Subjects randomized to receive the tNPWT system applied to the target ulcer area over the 12-week treatment period from Baseline.
|
|---|---|---|
|
Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Change in wound volume
|
-0.3 cm^3
Standard Deviation 0.3
|
0 cm^3
Standard Deviation 0.4
|
|
Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Baseline wound volume
|
0.3 cm^3
Standard Deviation 0.3
|
0.3 cm^3
Standard Deviation 0.3
|
|
Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Final wound volume
|
0.2 cm^3
Standard Deviation 0.5
|
0.1 cm^3
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Baseline through 12 weeksPopulation: Percentage change in wound depth and volume over 12-week treatment period by treatment group (PP population - all wounds)
Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm\^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device.
Outcome measures
| Measure |
PICO System
n=64 Participants
Subjects randomized to receive the PICO system applied to the target ulcer area over the 12-week treatment period from Baseline.
|
tNPWT System
n=51 Participants
Subjects randomized to receive the tNPWT system applied to the target ulcer area over the 12-week treatment period from Baseline.
|
|---|---|---|
|
Percentage Change in Target Ulcer Depth and Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Percentage change from baseline in wound depth
|
-68.8 percent change
Standard Deviation 59.4
|
-38.8 percent change
Standard Deviation 71.3
|
|
Percentage Change in Target Ulcer Depth and Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Percentage change from baseline in wound volume
|
-98.0 percent change
Standard Deviation 8.1
|
-10.1 percent change
Standard Deviation 207.8
|
Adverse Events
PICO System
Serious events: 6 serious events
Other events: 65 other events
Deaths: 2 deaths
tNPWT System
Serious events: 8 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PICO System
n=80 participants at risk
Subjects randomized to receive the PICO system applied to the target ulcer area over the 12-week treatment period from Baseline.
|
tNPWT System
n=84 participants at risk
Subjects randomized to receive the tNPWT system applied to the target ulcer area over the 12-week treatment period from Baseline.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Abscess
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 2 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Vascular disorders
Aneurysm
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Cardiac disorders
Congestive heart failure
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
2.4%
2/84 • Number of events 2 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Cardiac disorders
Diastolic heart failure
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
2.4%
2/84 • Number of events 2 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Fluid collection
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Psychiatric disorders
Psychiatric evaluation
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Blood and lymphatic system disorders
Sepsis
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Psychiatric disorders
Suicide
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Ulcer increased in size
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Wound infection
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
Other adverse events
| Measure |
PICO System
n=80 participants at risk
Subjects randomized to receive the PICO system applied to the target ulcer area over the 12-week treatment period from Baseline.
|
tNPWT System
n=84 participants at risk
Subjects randomized to receive the tNPWT system applied to the target ulcer area over the 12-week treatment period from Baseline.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Target ulcer increase in size > 75% from Baseline
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
6.0%
5/84 • Number of events 5 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Excessive maceration
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Excessive intermittent maceration right plantar forefoot target ulcer
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Vascular disorders
Deep venous thrombosis right lower leg
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Right lateral midfoot blister
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Increased peri-wound maceration
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Target venous leg ulcer maceration
|
1.2%
1/80 • Number of events 2 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Subject could not tolerated NPWT, it was uncomfortable for the subject
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Peri-ulcer tissue very macerated
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 2 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Left foot target ulcer cellulitis
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Infections and infestations
Methicillin-resistant Staphylococcus aureus infection
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Infections and infestations
Target ulcer infection
|
2.5%
2/80 • Number of events 2 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
3.6%
3/84 • Number of events 3 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Cellulitis to left 3rd interspace
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Subjective complaint of ulcer pain
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Injury, poisoning and procedural complications
Abrasion at 10 o'clock from left distal dorsal TMA
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Cellulitis of left plantar medial midfoot
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Renal and urinary disorders
Urinary tract infection
|
1.2%
1/80 • Number of events 2 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Acute bronchitis
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Ear and labyrinth disorders
Right ear infection
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Right thigh fluid collection with right groin incision site related drainage
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Venous stasis ulcer pain
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Vascular disorders
High blood pressure
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Allergic contact dermatitis of the right leg
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Left ankle swelling
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Infections and infestations
Left sole wound infection
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Allergic contact dermatitis of skin surrounding right foot ulcer
|
1.2%
1/80 • Number of events 2 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis, xerosis
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Erythema intertrigo
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Peri-wound maceration on left foot
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Peri-wound margin increase in maceration
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Wound increased in size
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Regression in wound - size of wound increased by more than 75% from last visit
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Peri-wound maceration on right foot
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 2 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Wound macerated
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Pressure-related pain from negative pressure
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Peri-wound maceration
|
7.5%
6/80 • Number of events 7 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
7.1%
6/84 • Number of events 12 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Pruritus RLE
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Blistered skin right lower extremity
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Probable osteomyelitis right foot at target ulcer
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Excoriations, maceration peri-wound
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Macerated skin left leg
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Redness, swelling, and discomfort right leg
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Progressive disease - worsening of target ulcer causing subject to be discontinued from study
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Cardiac disorders
Worsening of coronary artery disease
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Femur fracture
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
General disorders
Fall
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Infected pimple on face
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
DFU (target ulcer) progressive disease
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Target wound pain
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
New non-target ulcer near target ulcer on right shin
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
New non-target ulcer near target ulcer 0.5 cm in size
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Target wound pain decreased
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Debridement pain on target ulcer
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
2.4%
2/84 • Number of events 2 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Right upper quadrant/back pain
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Non-target ulcer on lateral side of left leg
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Multiple skin tears around target ulcer site
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Water blister on medial side of left leg
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Skin tear adjacent to target ulcer on left leg
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Three skin tears 2 cm away from target wound
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Non-target wound on right lateral ankle
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Maceration
|
2.5%
2/80 • Number of events 2 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
4.8%
4/84 • Number of events 7 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Two skin tears away from target wound (anterior)
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Two skin tears posterior to left leg
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Multple skin tears from target wound anterior left leg
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Non-target wound on left leg
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Small irritations around where dressing puts pressure on left leg
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Infections and infestations
Left medial ankle venous leg ulcer bacterial colonization of wound bed
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Peri-wound skin irritated
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Right target ulcer larger
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Venous ulcer right leg malleolus increase in wound size
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Cellulitis of right foot
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Wet gangrene 4th digit left foot
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Peri-wound inflammation target leg left VLU
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Large amount of drainage from target ulcer, left leg calf
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Foot edema
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Foot blistering on dorsal and medial surface
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Infections and infestations
Suspected non-target ulcer infection
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Formed a blister on anterior shin from tNPWT bridge
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Venous leg ulcer on left lateral leg
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Ulcer on dorsal portion of right foot
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Worsening of left ankle pain
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Gastrointestinal disorders
Abdominal pain, epigastric
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Psychiatric disorders
Episode of recurrent major depressive disorder
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis of ankle/foot
|
2.5%
2/80 • Number of events 2 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Bilateral lower extremity edema
|
2.5%
2/80 • Number of events 2 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea on exertion
|
1.2%
1/80 • Number of events 2 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Renal and urinary disorders
Acute urinary retention
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Renal and urinary disorders
Complication of Foley catheter
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Gastrointestinal disorders
Acute abdominal pain
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Edema, unspecified
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Suspected cellulitis
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Intermittent burning/stabbing pain x1 week
|
1.2%
1/80 • Number of events 2 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Left side of nose epidermal inclusion cyst
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Left lower abdomen epidermal cyst inflamed
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Left lower leg swelling
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Prolonged pain at target ulcer
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
3/80 • Number of events 3 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Bone exposure at target ulcer
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Wound undermining < 2 cm
|
3.8%
3/80 • Number of events 3 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Bulla right foot lateral side
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Progressive disease - wound size met the definition of progressive disease
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Burning pain in foot of target ulcer
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Gastrointestinal disorders
Epigastric pain
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Target ulcer pain
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Scrotal edema
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis on left foot
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Cardiac disorders
Acute on chronic congestive heart failure
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Cardiac disorders
Paroxysmal atrial fibrillation
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Infections and infestations
Wound infection
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Bone necrosis
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Left ankle and lower leg pain
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Body rash
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Additional ulcer left ankle
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Right mid thigh lacerations
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Increased maceration
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Fracture of vertebral disk
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Reopening of ulcers on target limb
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Worsening of recurring non-target ulcers on target limb
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Worsening of target ulcer
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
3.6%
3/84 • Number of events 3 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract infection
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Redness, skin breakdown to target limb
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
0.00%
0/84 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
|
Skin and subcutaneous tissue disorders
Swelling of the right foot
|
0.00%
0/80 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place