Trial Outcomes & Findings for TWB-103 for Treating Lower Limb Ulcers on Patients With DM (NCT NCT03624023)
NCT ID: NCT03624023
Last Updated: 2023-07-12
Results Overview
Pre-existing abnormalities are considered as AE or SAE only when the conditions escalate. The following events should be discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Day 1~ Day 169
Results posted on
2023-07-12
Participant Flow
This study was designed in a Phase I/II, single-arm manner. This study planned to enroll 10 subjects (including 8 evaluable per-protocol subjects) with diabetic lower limb ulcers for treating with up to 12 weekly applications of TWB-103 and evaluating the safety and efficacy.
Eligibility was checked during screening and at Day 1 Visit. The potential subjects with diabetic lower limb ulcer were arranged to receive standard of care only for at least 2 weeks during screening period. The standard of care was performed at the investigator's discretion based on the condition of each subject. Any subject whose study ulcer size decreases by 30% or more after this standard of care was excluded from the study.
Participant milestones
| Measure |
TWB-103
TWB-103 will be applied to the target ulcer wound once a week by the investigator, starting from Day 1, until wound closure is confirmed or up to 12 weekly applications
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TWB-103 for Treating Lower Limb Ulcers on Patients With DM
Baseline characteristics by cohort
| Measure |
TWB-103
n=10 Participants
TWB-103 will be applied to the target ulcer wound once a week by the investigator, starting from Day 1, until wound closure is confirmed or up to 12 weekly applications
|
|---|---|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 18.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
10 participants
n=5 Participants
|
|
Sum of Target Ulcer Surface Area
Sum of Target Ulcer Surface Area before Standard-of-Care
|
3.1 cm^2
STANDARD_DEVIATION 2.42 • n=5 Participants
|
|
Sum of Target Ulcer Surface Area
Sum of Target Ulcer Surface Area after Standard-of-Care
|
2.8 cm^2
STANDARD_DEVIATION 2.12 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1~ Day 169Population: All Subject Population.
Pre-existing abnormalities are considered as AE or SAE only when the conditions escalate. The following events should be discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
Outcome measures
| Measure |
TWB-103
n=10 Participants
TWB-103 will be applied to the target ulcer wound once a week by the investigator, starting from Day 1, until wound closure is confirmed or up to 12 weekly applications
|
|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
8 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 1 ~ Week 12Population: All Subject Population.
Wound closure is defined as "full epithelialization of the wound with the absence of drainage and without sign of abscess under the epithelium". An ulcer is considered healed only after wound closure is re-confirmed at the visit 2 weeks later.
Outcome measures
| Measure |
TWB-103
n=10 Participants
TWB-103 will be applied to the target ulcer wound once a week by the investigator, starting from Day 1, until wound closure is confirmed or up to 12 weekly applications
|
|---|---|
|
The Percentage of Subjects With Confirmed Study Wound Closure at Each Week up to 12 Weeks.
Adjusted Visit 3 (Week 1) with LOCF
|
0 Participants
|
|
The Percentage of Subjects With Confirmed Study Wound Closure at Each Week up to 12 Weeks.
Adjusted Visit 4 (Week 2) with LOCF
|
0 Participants
|
|
The Percentage of Subjects With Confirmed Study Wound Closure at Each Week up to 12 Weeks.
Adjusted Visit 5 (Week 3) with LOCF
|
1 Participants
|
|
The Percentage of Subjects With Confirmed Study Wound Closure at Each Week up to 12 Weeks.
Adjusted Visit 6 (Week 4) with LOCF
|
1 Participants
|
|
The Percentage of Subjects With Confirmed Study Wound Closure at Each Week up to 12 Weeks.
Adjusted Visit 7 (Week 5) with LOCF
|
1 Participants
|
|
The Percentage of Subjects With Confirmed Study Wound Closure at Each Week up to 12 Weeks.
Adjusted Visit 8 (Week 6) with LOCF
|
2 Participants
|
|
The Percentage of Subjects With Confirmed Study Wound Closure at Each Week up to 12 Weeks.
Adjusted Visit 9 (Week 7) with LOCF
|
2 Participants
|
|
The Percentage of Subjects With Confirmed Study Wound Closure at Each Week up to 12 Weeks.
Adjusted Visit 10 (Week 8) with LOCF
|
3 Participants
|
|
The Percentage of Subjects With Confirmed Study Wound Closure at Each Week up to 12 Weeks.
Adjusted Visit 11 (Week 9) with LOCF
|
5 Participants
|
|
The Percentage of Subjects With Confirmed Study Wound Closure at Each Week up to 12 Weeks.
Adjusted Visit 12 (Week 10) with LOCF
|
5 Participants
|
|
The Percentage of Subjects With Confirmed Study Wound Closure at Each Week up to 12 Weeks.
Adjusted Visit 13 (Week 11) with LOCF
|
6 Participants
|
|
The Percentage of Subjects With Confirmed Study Wound Closure at Each Week up to 12 Weeks.
Adjusted Visit 14 (Week 12) with LOCF
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 1 ~ Week 12Population: All Subject Population. Median time to confirmed ulcer closure up to EOS (End of Study) was also 70 days (Range: 21 \~ 77 days) since no confirmed wound closure occurred after 12 weeks.
Wound closure is defined as "full epithelialization of the wound with the absence of drainage and without sign of abscess under the epithelium". An ulcer is considered healed only after wound closure is re-confirmed at the visit 2 weeks later.
Outcome measures
| Measure |
TWB-103
n=10 Participants
TWB-103 will be applied to the target ulcer wound once a week by the investigator, starting from Day 1, until wound closure is confirmed or up to 12 weekly applications
|
|---|---|
|
Time to Confirmed Wound Closure for Those Subjects Whose Wounds Are Healed During Treatment Period and During the Study Period.
Time to Target Ulcer Closure within 12 Weeks
|
70 days
Interval 21.0 to 77.0
|
|
Time to Confirmed Wound Closure for Those Subjects Whose Wounds Are Healed During Treatment Period and During the Study Period.
Time to Confirmed Ulcer Closure Up to EOS Visit
|
70 days
Interval 21.0 to 77.0
|
SECONDARY outcome
Timeframe: Week 1~ Week 12Population: All Subject Population.
The surface area of the ulcer was estimated in the manner as follows. The ulcer along with an ulcer measuring ruler (OPSITETM transparent film) was photographed. An OPSITETM transparent film was placed on the wound and the wound area was traced on the film. The images were processed and analyzed using the ImageJ software package. The ImageJ software read the computed tomographic data and calibrated the images automatically.
Outcome measures
| Measure |
TWB-103
n=10 Participants
TWB-103 will be applied to the target ulcer wound once a week by the investigator, starting from Day 1, until wound closure is confirmed or up to 12 weekly applications
|
|---|---|
|
Change of Individual Wound Area for up to 12 Weeks.
Baseline
|
2.78 cm^2
Standard Deviation 2.124
|
|
Change of Individual Wound Area for up to 12 Weeks.
Adjusted Visit 14 (Week 12) with LOCF
|
0.52 cm^2
Standard Deviation 0.904
|
|
Change of Individual Wound Area for up to 12 Weeks.
Net Change
|
-2.26 cm^2
Standard Deviation 1.941
|
SECONDARY outcome
Timeframe: Week 1 ~ Week 12Population: All Subject Population.
The surface area of the ulcer was estimated in the manner as follows. The ulcer along with an ulcer measuring ruler (OPSITETM transparent film) was photographed. An OPSITETM transparent film was placed on the wound and the wound area was traced on the film. The images were processed and analyzed using the ImageJ software package. The ImageJ software read the computed tomographic data and calibrated the images automatically.
Outcome measures
| Measure |
TWB-103
n=10 Participants
TWB-103 will be applied to the target ulcer wound once a week by the investigator, starting from Day 1, until wound closure is confirmed or up to 12 weekly applications
|
|---|---|
|
Change of Wound Area at Each Week up to 12 Weeks.
Baseline
|
2.78 cm^2
Standard Deviation 2.124
|
|
Change of Wound Area at Each Week up to 12 Weeks.
Adjusted Visit 3 (Week 1) with LOCF
|
2.19 cm^2
Standard Deviation 1.963
|
|
Change of Wound Area at Each Week up to 12 Weeks.
Adjusted Visit 4 (Week 2) with LOCF
|
1.65 cm^2
Standard Deviation 1.728
|
|
Change of Wound Area at Each Week up to 12 Weeks.
Adjusted Visit 5 (Week 3) with LOCF
|
1.70 cm^2
Standard Deviation 1.569
|
|
Change of Wound Area at Each Week up to 12 Weeks.
Adjusted Visit 6 (Week 4) with LOCF
|
1.40 cm^2
Standard Deviation 1.531
|
|
Change of Wound Area at Each Week up to 12 Weeks.
Adjusted Visit 7 (Week 5) with LOCF
|
1.21 cm^2
Standard Deviation 1.420
|
|
Change of Wound Area at Each Week up to 12 Weeks.
Adjusted Visit 8 (Week 6) with LOCF
|
1.09 cm^2
Standard Deviation 1.421
|
|
Change of Wound Area at Each Week up to 12 Weeks.
Adjusted Visit 9 (Week 7) with LOCF
|
1.00 cm^2
Standard Deviation 1.380
|
|
Change of Wound Area at Each Week up to 12 Weeks.
Adjusted Visit 10 (Week 8) with LOCF
|
0.75 cm^2
Standard Deviation 1.183
|
|
Change of Wound Area at Each Week up to 12 Weeks.
Adjusted Visit 11 (Week 9) with LOCF
|
0.62 cm^2
Standard Deviation 1.058
|
|
Change of Wound Area at Each Week up to 12 Weeks.
Adjusted Visit 12 (Week 10) with LOCF
|
0.68 cm^2
Standard Deviation 0.944
|
|
Change of Wound Area at Each Week up to 12 Weeks.
Adjusted Visit 13 (Week 11) with LOCF
|
0.96 cm^2
Standard Deviation 1.469
|
|
Change of Wound Area at Each Week up to 12 Weeks.
Adjusted Visit 14 (Week 12) with LOCF
|
0.52 cm^2
Standard Deviation 0.904
|
SECONDARY outcome
Timeframe: Week 1 ~ Week 12Population: Data were not collected.
The granulation rate was recorded by comments from the investigator. Healthy granulation tissue was pink to red, moist and shiny. Forming of healthy granulation tissue provided foundation for epithelialization and was an indicator of healing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 1 ~ Week 12Population: Data were not collected.
The quality of granulation tissue was recorded by comments from the investigator. Healthy granulation tissue was pink to red, moist and shiny. Forming of healthy granulation tissue provided foundation for epithelialization and was an indicator of healing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 1 ~ Week 12Population: There was only one measurement which was performed for one subject at Visit 8.
For changes of (if data available) wound volume measured by the 3D camera from the baseline values, data was analyzed using one-sample t-test or Wilcoxon sign rank test. (Only for those subjects who have received the 3D measurement)
Outcome measures
| Measure |
TWB-103
n=1 Participants
TWB-103 will be applied to the target ulcer wound once a week by the investigator, starting from Day 1, until wound closure is confirmed or up to 12 weekly applications
|
|---|---|
|
Change of Wound Volume for Individual Subject Measured by 3D Camera and Analysis Software up to 12 Weeks.
|
0.11 cm^3
Interval 0.11 to 0.11
|
Adverse Events
TWB-103
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TWB-103
n=10 participants at risk
TWB-103 will be applied to the target ulcer wound once a week by the investigator, starting from Day 1, until wound closure is confirmed or up to 12 weekly applications
|
|---|---|
|
Cardiac disorders
Coronary artery disease
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Eye disorders
Glaucoma
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Infections and infestations
Tuberculosis
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Immune system disorders
Anaphylactic shock
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
Other adverse events
| Measure |
TWB-103
n=10 participants at risk
TWB-103 will be applied to the target ulcer wound once a week by the investigator, starting from Day 1, until wound closure is confirmed or up to 12 weekly applications
|
|---|---|
|
Cardiac disorders
Coronary artery disease
|
10.0%
1/10 • Number of events 2 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Cardiac disorders
Ventricular tachycardia
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Ear and labyrinth disorders
Vertigo positional
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Eye disorders
Dry eye
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Eye disorders
Glaucoma
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
General disorders
Application site erosion
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
General disorders
Chest pain
|
10.0%
1/10 • Number of events 2 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Immune system disorders
Anaphylactic shock
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Infections and infestations
Application site cellulitis
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Infections and infestations
Application site infection
|
20.0%
2/10 • Number of events 2 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Infections and infestations
Tinea pedis
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Infections and infestations
Tuberculosis
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Infections and infestations
Vestibular neuronitis
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Metabolism and nutrition disorders
Cachexia
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Renal and urinary disorders
Chronic kidney disease
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
|
Skin and subcutaneous tissue disorders
Sweat gland disorder
|
10.0%
1/10 • Number of events 1 • Day 1 ~ Day 169
The following events were discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place