Pressure UlcerNCT02863263
Efficacy and Safety of MedifoamⓇ and BetafoamⓇ in Pressure Ulcer
A study testing Foam Dressing and Foam Dressing with Povidone Iodine in people with Pressure Ulcer, run by Mundipharma Pte Ltd. at 1 site in South Korea.
Trial summary
This study aims to exploratively assess the efficacy and safety of hydrophilic polyurethane foam dressing (MedifoamⓇ or BetafoamⓇ) in pressure ulcer specifically. The target enrolment is 20 patients, with 10 patients per arm. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Foam Dressing and Foam Dressing with Povidone Iodine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jul 2016to 26 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged at least 19 years old as of the consent date
- Pressure ulcer of National Pressure Ulcer Advisory Panel (NPUAP) Stage III at screening
- Pressure ulcer size of 3-10 cm2 at screening
- Written consent provided by the subject or representative
Who cannot join
- Any study ulcer of NPUAP Stage I, II or IV
- Diabetic ulcer or venous ulcer (or stasis ulcer)
- Past history of surgical treatment within 1 year or irradiation at the target pressure ulcer within 1 year
- Hypersensitivity reaction to this product or povidone iodine
- Hyperthyroidism or thyroid disorder requiring drug treatment
- Signs of a current underlying systemic infection (sepsis/bacterial infection/tuberculosis) or cellulitis or osteomyelitis
Show all 14Show fewer
- Type 1 diabetes
- Current malnutrition
- Heavy smoker: Current smoking level of ≥1 pack (20 cigarettes)/day of tobacco
- Drug or alcohol addiction
- Requirement of immune-suppressants during the study, or current chemotherapy or radiotherapy
- Application of other investigational product/medical device within 1 month prior to the investigational device application
- Pregnant or breast-feeding women
- Other renal, hepatic, neurological or immunological disorder that may interfere with the wound healing process, at the discretion of the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Evaluate Efficacy and Safety of Hydrophilic Polyurethane Foam Dressing in Patients With Pressure Ulcer
This study aims to exploratively assess the efficacy and safety of hydrophilic polyurethane foam dressing (MedifoamⓇ or BetafoamⓇ) in pressure ulcer specifically. The target enrolment is 20 patients, with 10 patients per arm.
Read the detailed description
As the primary objective, the percentage of completely healed patients and the time to complete healing will be assessed after applying the study device, MedifoamⓇ or BetafoamⓇ, for 12 weeks to pressure ulcer patients. In addition, the pressure ulcer size reduction rate over 12 weeks will be evaluated.
Patients will make once weekly site visits. There are 14 visits in total, including a screening visit 14 days (maximum) before the baseline visit.
- Conditions
- Pressure Ulcer
- Being tested
- Foam Dressing, Foam Dressing with Povidone Iodine
- Keywords
- foam dressing, MedifoamⓇ, BetafoamⓇ, povidone iodine
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foam DressingDevice
Also called Brand name: MedifoamⓇ
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 IodineDevice
Also called Brand name: BetafoamⓇ
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.
| Study group | Role | What they receive |
|---|---|---|
| Foam Dressing | Other | 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. Receives: Device: Foam Dressing |
| Foam Dressing with Povidone Iodine | Other | 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. Receives: Device: Foam Dressing with Povidone Iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With 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.
Measured: 12 weeks
Time to Complete Healing of Ulcer Within 12 Weeks as Measured by Number of Days From Baseline
Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration.
Measured: 12 weeks
Pressure Ulcer Size Measured Using A Ruler at Week 12
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.
Measured: Week 12 (Or Last Observation Carried Forward)
Secondary outcomes (4)
Pressure Ulcer Scale for Healing (PUSH) Score Measured Using PUSH Tool Version 3.0 At Week 12
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
Measured: Week 12 (Or Last Observation Carried Forward)
Number of Participants With a Dressing Change Frequency Greater Than Twice Per Week
Measured: 12 weeks
Number of Patients Achieving Early Study Completion Due to Complete Healing
Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration.
Measured: 12 weeks
Number of Participants With New Infections at the Pressure Ulcer Based on Clinical Signs and Symptoms Checklist (CCSC)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start29 Jul 2016
- Primary completion26 Jul 2017
- Study completion26 Jul 2017
Why it stopped: Difficulties in meeting recruitment target
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Pte Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harsha Arumugam, Study director, Mundipharma Singapore Holding Pte. Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863263
- Sponsor's protocol ID
- BTF16-AP-401
- Status last verified
- May 2019
- First submitted
- 8 Aug 2016
- Last updated
- 15 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Efficacy and Safety of Hydrophilic Polyurethane Foam Dressing in Patients With Pressure Ulcer
- ClinicalTrials.gov ID
- NCT02863263
- Acronym / sponsor ID
- BTF16-AP-401
- Conditions
- Pressure Ulcer
- Keywords
- foam dressing, MedifoamⓇ, BetafoamⓇ, povidone iodine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in meeting recruitment target
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Mundipharma Pte Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2016 (actual)
- Primary completion
- 26 Jul 2017 (actual)
- Study completion
- 26 Jul 2017 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Posted 15 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to exploratively assess the efficacy and safety of hydrophilic polyurethane foam dressing (MedifoamⓇ or BetafoamⓇ) in pressure ulcer specifically. The target enrolment is 20 patients, with 10 patients per arm.
Detailed description
As the primary objective, the percentage of completely healed patients and the time to complete healing will be assessed after applying the study device, MedifoamⓇ or BetafoamⓇ, for 12 weeks to pressure ulcer patients. In addition, the pressure ulcer size reduction rate over 12 weeks will be evaluated.
Patients will make once weekly site visits. There are 14 visits in total, including a screening visit 14 days (maximum) before the baseline visit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foam Dressing | Other | Device: Foam DressingOver 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 | Other | Device: Foam Dressing with Povidone IodineOver 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged at least 19 years old as of the consent date
- Pressure ulcer of National Pressure Ulcer Advisory Panel (NPUAP) Stage III at screening
- Pressure ulcer size of 3-10 cm2 at screening
- Written consent provided by the subject or representative
Key exclusion criteria (14 listed)
- Any study ulcer of NPUAP Stage I, II or IV
- Diabetic ulcer or venous ulcer (or stasis ulcer)
- Past history of surgical treatment within 1 year or irradiation at the target pressure ulcer within 1 year
- Hypersensitivity reaction to this product or povidone iodine
- Hyperthyroidism or thyroid disorder requiring drug treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foam DressingAlso: Brand name: MedifoamⓇ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. | Device | Foam Dressing |
| Foam Dressing with Povidone IodineAlso: Brand name: BetafoamⓇ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. | Device | Foam Dressing with Povidone Iodine |
Primary outcome
Number of Patients With Complete Healing of Ulcer Within 12 Weeks
Time frame: 12 weeks
Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration.
Time to Complete Healing of Ulcer Within 12 Weeks as Measured by Number of Days From Baseline
Time frame: 12 weeks
Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration.
Pressure Ulcer Size Measured Using A Ruler at Week 12
Time frame: Week 12 (Or Last Observation Carried Forward)
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.
4 secondary outcomes
Pressure Ulcer Scale for Healing (PUSH) Score Measured Using PUSH Tool Version 3.0 At Week 12
Time frame: Week 12 (Or Last Observation Carried Forward)
Number of Participants With a Dressing Change Frequency Greater Than Twice Per Week
Time frame: 12 weeks
Number of Patients Achieving Early Study Completion Due to Complete Healing
Time frame: 12 weeks
Number of Participants With New Infections at the Pressure Ulcer Based on Clinical Signs and Symptoms Checklist (CCSC)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harsha Arumugam study director
Mundipharma Singapore Holding Pte. Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foam Dressing and Foam Dressing with Povidone Iodine in people with Pressure Ulcer, run by Mundipharma Pte Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Complete Healing of Ulcer Within 12 Weeks (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.