Trial Outcomes & Findings for Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers (NCT NCT02326337)
NCT ID: NCT02326337
Last Updated: 2025-10-27
Results Overview
Number of Participants with complete wound closure defined as 100% skin re-epithelialization without dressing requirements which is confirmed by 2 consecutive study visits 2 weeks apart.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
73 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-10-27
Participant Flow
Participant milestones
| Measure |
Topical Wound Oxygen Device
Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with Advanced Moist Wound Therapy (AMWT) dressings.
Other Names:
* Topical Wound Oxygen Therapy
* TWO2
TWO2 Device: Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
|
Placebo Device
Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
Placebo Device: Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
37
|
|
Overall Study
COMPLETED
|
36
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers
Baseline characteristics by cohort
| Measure |
Topical Wound Oxygen Device
n=36 Participants
Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with Advanced Moist Wound Therapy (AMWT) dressings.
Other Names:
* Topical Wound Oxygen Therapy
* TWO2
TWO2 Device: Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
|
Placebo Device
n=37 Participants
Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
Placebo Device: Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
61.9 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
63.3 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Hispanic
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Diabetes Type 2
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
BMI
|
30.8 Kg/m^2
STANDARD_DEVIATION 5.9 • n=5 Participants
|
31.2 Kg/m^2
STANDARD_DEVIATION 7.6 • n=7 Participants
|
31 Kg/m^2
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Wound area (cm2)
|
3.02 cm^2
STANDARD_DEVIATION 2.66 • n=5 Participants
|
3.22 cm^2
STANDARD_DEVIATION 2.54 • n=7 Participants
|
3.13 cm^2
STANDARD_DEVIATION 2.57 • n=5 Participants
|
|
Wound perimeter (cm)
|
6.22 cm
STANDARD_DEVIATION 2.85 • n=5 Participants
|
6.85 cm
STANDARD_DEVIATION 4.18 • n=7 Participants
|
6.54 cm
STANDARD_DEVIATION 3.55 • n=5 Participants
|
|
Ulcer duration (days)
|
160.3 Days
STANDARD_DEVIATION 96 • n=5 Participants
|
174.6 Days
STANDARD_DEVIATION 94 • n=7 Participants
|
166.4 Days
STANDARD_DEVIATION 95 • n=5 Participants
|
|
The University of Texas Staging System for Diabetic Foot Ulcers Grade I
|
22 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
The University of Texas Staging System for Diabetic Foot Ulcers Grade II
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Neuropathic foot
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Smoker
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ankle brachial index, ratio (SD)
|
1.07 Ratio
STANDARD_DEVIATION 0.23 • n=5 Participants
|
1.00 Ratio
STANDARD_DEVIATION 0.23 • n=7 Participants
|
1.03 Ratio
STANDARD_DEVIATION 0.23 • n=5 Participants
|
|
HbA1c, % (SD)
|
8.43 Percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.75 • n=5 Participants
|
8.14 Percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.49 • n=7 Participants
|
8.25 Percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.64 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Patients with diabetic foot ulcers
Number of Participants with complete wound closure defined as 100% skin re-epithelialization without dressing requirements which is confirmed by 2 consecutive study visits 2 weeks apart.
Outcome measures
| Measure |
Topical Wound Oxygen Device
n=36 Participants
Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with Advanced Moist Wound Therapy (AMWT) dressings.
Other Names:
* Topical Wound Oxygen Therapy
* TWO2
TWO2 Device: Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
|
Placebo Device
n=37 Participants
Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
Placebo Device: Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
|
|---|---|---|
|
Wound Closure Within 12 Weeks With the Use of Topical Wound Oxygen Therapy (TWO2)
|
15 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Patients with open ulcers
Absolute change in ulcer area over 12 weeks in cm2
Outcome measures
| Measure |
Topical Wound Oxygen Device
n=36 Participants
Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with Advanced Moist Wound Therapy (AMWT) dressings.
Other Names:
* Topical Wound Oxygen Therapy
* TWO2
TWO2 Device: Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
|
Placebo Device
n=37 Participants
Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
Placebo Device: Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
|
|---|---|---|
|
Absolute Change in Ulcer Area
|
1.97 cm2
Standard Deviation 2.12
|
.4 cm2
Standard Deviation 0.041
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Patient with closed diabetic foot ulcers
Number of diabetic foot ulcers with recurrence at 12 months
Outcome measures
| Measure |
Topical Wound Oxygen Device
n=15 Participants
Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with Advanced Moist Wound Therapy (AMWT) dressings.
Other Names:
* Topical Wound Oxygen Therapy
* TWO2
TWO2 Device: Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
|
Placebo Device
n=5 Participants
Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
Placebo Device: Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
|
|---|---|---|
|
Ulcer Recurrence
|
1 Count of wounds with recurrence
|
2 Count of wounds with recurrence
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Patients with Index limb amputations
Number of amputation events during interventional period of the study.
Outcome measures
| Measure |
Topical Wound Oxygen Device
n=36 Participants
Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with Advanced Moist Wound Therapy (AMWT) dressings.
Other Names:
* Topical Wound Oxygen Therapy
* TWO2
TWO2 Device: Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
|
Placebo Device
n=37 Participants
Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
Placebo Device: Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
|
|---|---|---|
|
Number of Amputation Events
|
2 Count of events
|
3 Count of events
|
SECONDARY outcome
Timeframe: 54 weeksPopulation: Patients with diabetic foot ulcers
Incidence of serious adverse events and adverse events
Outcome measures
| Measure |
Topical Wound Oxygen Device
n=36 Participants
Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with Advanced Moist Wound Therapy (AMWT) dressings.
Other Names:
* Topical Wound Oxygen Therapy
* TWO2
TWO2 Device: Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
|
Placebo Device
n=37 Participants
Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
Placebo Device: Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
|
|---|---|---|
|
Incidence of Adverse Events
Serious Adverse Events
|
10 Count of events
|
10 Count of events
|
|
Incidence of Adverse Events
Adverse Events
|
8 Count of events
|
8 Count of events
|
|
Incidence of Adverse Events
Device related death
|
0 Count of events
|
0 Count of events
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Study participants with open and healed ulcers.
The Cardiff Wound Impact Schedule questionnaire to measure quality of life. Measure of well-being items from each scale are summated, physical symptoms, everyday living and social life. The items are rated for the extent of the experience and each item is given a number value. This allows the patients to weight the items included in the scale. The well-being scale is scored on a 5-point Likert scale, with response options from 'strongly agree' to 'strongly disagree'. All three scales are then transformed onto a minimum = 0 up to a maximum = 100, where a low score indicates worse, and a high score indicates better feeling of well-being.
Outcome measures
| Measure |
Topical Wound Oxygen Device
n=36 Participants
Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with Advanced Moist Wound Therapy (AMWT) dressings.
Other Names:
* Topical Wound Oxygen Therapy
* TWO2
TWO2 Device: Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
|
Placebo Device
n=37 Participants
Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
Placebo Device: Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
|
|---|---|---|
|
Quality of Life Assessment
|
9.1 units on a scale
Standard Deviation 13.9
|
0.1 units on a scale
Standard Deviation 16.9
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Patients with diabetic foot ulcers
Not performed or reported. Economic Analysis is a composite measure of the wound before the study (up to one year) and for the duration of the study. The assessment is obtained by documenting treatment history of the wound that includes types of dressings used, time taken for dressing changes, by whom dressings are changed, and type and duration of hospitalization as well as the administration of the EQ-5D questionnaire at the Baseline visit, weeks 4, 8 and 12 on treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks or wound closurePopulation: Time to complete wound closure, weeks.
Time to 100% wound closure utilizing Cox proportional hazards model, a statistical measure of difference of time to event (healing). Subjects who withdraw from treatment will be entered into the analysis and censored at the time they withdraw from the trial or are lost to follow up. The analysis will consider covariates that might influence the outcome in the trial.
Outcome measures
| Measure |
Topical Wound Oxygen Device
n=36 Participants
Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with Advanced Moist Wound Therapy (AMWT) dressings.
Other Names:
* Topical Wound Oxygen Therapy
* TWO2
TWO2 Device: Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
|
Placebo Device
n=37 Participants
Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
Placebo Device: Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
|
|---|---|---|
|
Time to Complete Wound Closure in Weeks
|
8.2 Weeks
Standard Deviation 1.9
|
6.3 Weeks
Standard Deviation 4.2
|
Adverse Events
Topical Wound Oxygen Device
Serious events: 6 serious events
Other events: 6 other events
Deaths: 2 deaths
Placebo Device
Serious events: 7 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Topical Wound Oxygen Device
n=36 participants at risk
Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with Advanced Moist Wound Therapy (AMWT) dressings.
Other Names:
* Topical Wound Oxygen Therapy
* TWO2
TWO2 Device: Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
|
Placebo Device
n=37 participants at risk
Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
Placebo Device: Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Wound Infection
|
8.3%
3/36 • Number of events 3 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
5.4%
2/37 • Number of events 2 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
5.6%
2/36 • Number of events 2 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
13.5%
5/37 • Number of events 5 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
|
Endocrine disorders
Hyperglycemic event
|
0.00%
0/36 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
2.7%
1/37 • Number of events 1 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
5.6%
2/36 • Number of events 2 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
0.00%
0/37 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
|
Skin and subcutaneous tissue disorders
Necrotic Tissue
|
0.00%
0/36 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
2.7%
1/37 • Number of events 1 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
|
Cardiac disorders
Cardiovascular Event
|
2.8%
1/36 • Number of events 1 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
0.00%
0/37 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
|
Skin and subcutaneous tissue disorders
UTC Grade II Ulceration
|
2.8%
1/36 • Number of events 1 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
0.00%
0/37 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
|
Skin and subcutaneous tissue disorders
Severe Maceration
|
0.00%
0/36 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
2.7%
1/37 • Number of events 1 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.8%
1/36 • Number of events 1 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
0.00%
0/37 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
Other adverse events
| Measure |
Topical Wound Oxygen Device
n=36 participants at risk
Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with Advanced Moist Wound Therapy (AMWT) dressings.
Other Names:
* Topical Wound Oxygen Therapy
* TWO2
TWO2 Device: Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
|
Placebo Device
n=37 participants at risk
Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
Placebo Device: Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
UTC Grade I Ulcer
|
8.3%
3/36 • Number of events 3 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
0.00%
0/37 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
|
Skin and subcutaneous tissue disorders
Ulcer Decline
|
5.6%
2/36 • Number of events 2 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
0.00%
0/37 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
|
Skin and subcutaneous tissue disorders
Minor Infection
|
2.8%
1/36 • Number of events 1 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
2.7%
1/37 • Number of events 1 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
|
Musculoskeletal and connective tissue disorders
Minor Osteomyelitis
|
2.8%
1/36 • Number of events 1 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
0.00%
0/37 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
|
Musculoskeletal and connective tissue disorders
Minor Necrotic Tissue
|
0.00%
0/36 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
2.7%
1/37 • Number of events 1 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/36 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
2.7%
1/37 • Number of events 1 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
|
Vascular disorders
Edema
|
2.8%
1/36 • Number of events 1 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
2.7%
1/37 • Number of events 1 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
|
Skin and subcutaneous tissue disorders
Maceration
|
0.00%
0/36 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
5.4%
2/37 • Number of events 2 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
|
Skin and subcutaneous tissue disorders
Deramatitis
|
0.00%
0/36 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
2.7%
1/37 • Number of events 1 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
|
Skin and subcutaneous tissue disorders
Contusion
|
0.00%
0/36 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
2.7%
1/37 • Number of events 1 • 54 Weeks (baseline up to maximum duration of study participation).
Adverse Events were collected and assessed at every study visit by investigator.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place