Trial Outcomes & Findings for Efficacy and Safety of MedifoamⓇ and BetafoamⓇ in Pressure Ulcer (NCT NCT02863263)

NCT ID: NCT02863263

Last Updated: 2019-05-15

Results Overview

Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 5 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2019-05-15

Participant Flow

Participant milestones

Measure	Foam Dressing Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. Foam Dressing: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device on its own. Subjects are randomised to one of 2 arms.	Foam Dressing With Povidone Iodine Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. Foam Dressing with Povidone Iodine: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device own. Subjects are randomised to one of 2 arms.
Overall Study STARTED	3	2
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Foam Dressing n=3 Participants Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. Foam Dressing: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device on its own. Subjects are randomised to one of 2 arms.	Foam Dressing With Povidone Iodine n=2 Participants Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. Foam Dressing with Povidone Iodine: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device own. Subjects are randomised to one of 2 arms.	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=3 Participants	0 Participants n=2 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=3 Participants	2 Participants n=2 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=3 Participants	2 Participants n=2 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=5 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment South Korea	3 Participants n=3 Participants	2 Participants n=2 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration.

Outcome measures

Measure	Foam Dressing n=3 Participants Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. Foam Dressing: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device on its own. Subjects are randomised to one of 2 arms.	Foam Dressing With Povidone Iodine n=2 Participants Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. Foam Dressing with Povidone Iodine: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device own. Subjects are randomised to one of 2 arms.
Number of Patients With Complete Healing of Ulcer Within 12 Weeks	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: There is no analysis and result for this outcome measure as none of the subjects achieved complete healing of ulcer within 12 weeks.

Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Week 12 (Or Last Observation Carried Forward)

Population: Statistical analysis for this outcome measure was not performed due to low enrolment and early study termination.

The ulcer area (for ulcers without re-epithelization) is measured at each visit after foam dressing application. A photograph of the ulcer is taken and a using a ruler (MediRuleⓇ) is used to measure its length and width to obtain the area in cm2.

Outcome measures

Measure	Foam Dressing n=3 Participants Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. Foam Dressing: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device on its own. Subjects are randomised to one of 2 arms.	Foam Dressing With Povidone Iodine n=2 Participants Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. Foam Dressing with Povidone Iodine: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device own. Subjects are randomised to one of 2 arms.
Pressure Ulcer Size Measured Using A Ruler at Week 12	5.05 cm2 Interval 1.0 to 9.1	2.8 cm2 Interval 0.5 to 5.1

SECONDARY outcome

Timeframe: Week 12 (Or Last Observation Carried Forward)

Population: Statistical analysis for this outcome measure was not performed due to low enrolment and early study termination.

The PUSH score is measured at alternate visits (2-week intervals) starting from baseline and will be compared against baseline.

Minimum score= 0 Maximum score: 17 Higher score: worse outcome

Outcome measures

Measure	Foam Dressing n=3 Participants Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. Foam Dressing: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device on its own. Subjects are randomised to one of 2 arms.	Foam Dressing With Povidone Iodine n=2 Participants Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. Foam Dressing with Povidone Iodine: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device own. Subjects are randomised to one of 2 arms.
Pressure Ulcer Scale for Healing (PUSH) Score Measured Using PUSH Tool Version 3.0 At Week 12	8 score on a scale Interval 5.0 to 11.0	7 score on a scale Interval 4.0 to 10.0

SECONDARY outcome

Timeframe: 12 weeks

Population: The original Outcome Measure was frequency of additional dressing change. However, statistical analysis for this outcome measure was not performed due to low enrolment and early study termination. Therefore, the number of participants with dressing changes of more than twice weekly is reported instead.

Outcome measures

Measure	Foam Dressing n=3 Participants Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. Foam Dressing: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device on its own. Subjects are randomised to one of 2 arms.	Foam Dressing With Povidone Iodine n=2 Participants Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. Foam Dressing with Povidone Iodine: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device own. Subjects are randomised to one of 2 arms.
Number of Participants With a Dressing Change Frequency Greater Than Twice Per Week	3 participants	2 participants

SECONDARY outcome

Timeframe: 12 weeks

Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration.

Outcome measures

Measure	Foam Dressing n=3 Participants Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. Foam Dressing: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device on its own. Subjects are randomised to one of 2 arms.	Foam Dressing With Povidone Iodine n=2 Participants Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. Foam Dressing with Povidone Iodine: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device own. Subjects are randomised to one of 2 arms.
Number of Patients Achieving Early Study Completion Due to Complete Healing	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 weeks

Patients with at least 1 new infection after the foam dressing application at baseline until Visit 14 will be taken into account.

Infection is defined as presence of purulent exudates or 2 or more symptoms stated in the CCSC. For patients with existing infection at baseline, infection is defined as the development of an additional symptom or recurrence of the baseline symptom after it was completely healed.

Outcome measures

Measure	Foam Dressing n=3 Participants Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. Foam Dressing: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device on its own. Subjects are randomised to one of 2 arms.	Foam Dressing With Povidone Iodine n=2 Participants Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. Foam Dressing with Povidone Iodine: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device own. Subjects are randomised to one of 2 arms.
Number of Participants With New Infections at the Pressure Ulcer Based on Clinical Signs and Symptoms Checklist (CCSC)	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Examples of these local events are erythema, edema, itching, flare and rash.

Outcome measures

Measure	Foam Dressing n=3 Participants Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. Foam Dressing: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device on its own. Subjects are randomised to one of 2 arms.	Foam Dressing With Povidone Iodine n=2 Participants Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. Foam Dressing with Povidone Iodine: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device own. Subjects are randomised to one of 2 arms.
Safety as Evaluated by Number of Local Adverse Events at the Target Pressure Ulcer	1 local adverse events	0 local adverse events

Adverse Events

Foam Dressing

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Foam Dressing With Povidone Iodine

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Foam Dressing n=3 participants at risk Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. Foam Dressing: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device on its own. Subjects are randomised to one of 2 arms.	Foam Dressing With Povidone Iodine n=2 participants at risk Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. Foam Dressing with Povidone Iodine: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device own. Subjects are randomised to one of 2 arms.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/3 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.	50.0% 1/2 • Number of events 1 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.

Other adverse events

Measure	Foam Dressing n=3 participants at risk Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. Foam Dressing: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device on its own. Subjects are randomised to one of 2 arms.	Foam Dressing With Povidone Iodine n=2 participants at risk Over the course of 12 weeks, dressing is performed twice weekly, but additional dressing changes are allowed, depending on the condition of the pressure ulcer such as excessive exudates on the ulcer. The frequency of dressing change is limited to once daily. Foam Dressing with Povidone Iodine: The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device own. Subjects are randomised to one of 2 arms.
General disorders Pyrexia	66.7% 2/3 • Number of events 3 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.	0.00% 0/2 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.
Skin and subcutaneous tissue disorders Erythema	33.3% 1/3 • Number of events 1 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.	0.00% 0/2 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.
Investigations Alanine aminotransferase increased	33.3% 1/3 • Number of events 1 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.	0.00% 0/2 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.
Investigations Aspartate aminotransferase increased	33.3% 1/3 • Number of events 1 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.	0.00% 0/2 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.	0.00% 0/2 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.
Skin and subcutaneous tissue disorders Decubitus ulcer	33.3% 1/3 • Number of events 1 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.	0.00% 0/2 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.
Psychiatric disorders Delirium	33.3% 1/3 • Number of events 1 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.	0.00% 0/2 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.
Nervous system disorders Dizziness	33.3% 1/3 • Number of events 1 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.	0.00% 0/2 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.
Vascular disorders Hypotension	33.3% 1/3 • Number of events 1 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.	0.00% 0/2 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.
Skin and subcutaneous tissue disorders Miliaria	33.3% 1/3 • Number of events 1 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.	0.00% 0/2 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.
Infections and infestations Pyuria	33.3% 1/3 • Number of events 1 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.	0.00% 0/2 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.
Injury, poisoning and procedural complications Skin abrasion	33.3% 1/3 • Number of events 1 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.	0.00% 0/2 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.
Investigations Urine output decreased	33.3% 1/3 • Number of events 1 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.	0.00% 0/2 • 12 weeks Method of systematic assessment: Physical examination was done at every visit and laboratory test was done at the last visit.

Additional Information

Valerie Anne Leck

Mundipharma Singapore Holding Pte. Limited

Phone: +65 6511 1165

Email: info.rma@mundipharma.com.sg

Results disclosure agreements

• Principal investigator is a sponsor employee Mundipharma Pte Ltd is owner of the data. No Investigator may publish the results of this study without prior approval from Mundipharma Pte Ltd.
• Publication restrictions are in place

Restriction type: OTHER