Leg Ulcers
Conditions
Brief summary
The objective of this investigation is to demonstrate the effectiveness and safety of Biatain Ibu non-adhesive foam dressing compared to Biatain non-adhesive foam dressing.
Interventions
DEVICEBiatain
A standard polyurethane foam dressing Biatain non-adhesive (Coloplast A/S) with an elastic semi-permeable backing film, size 15x15 cm. The product is CE marked.
DEVICEBiatain Ibu
Biatain Ibu non-adhesive (Coloplast A/S), a polyurethane foam dressing with an elastic semi-permeable backing film with an added pain relieving medicinal substance ibuprofen (Albermarle Inc.), size 15x15 cm. The product is CE marked.
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>= 18 years of age * Chronic venous leg ulcer on the lower leg * Ulcer duration \>= 8 weeks * Pain intensity in study ulcer at least 4 on an 11-point numerical box scale (NBS): 0= no pain, 10= worst possible pain * Exudate level moderate to high * Ulcer size min 1.6 cm and max 11 cm in any direction * Ankle/brachial index \>= 0.8 * Treated with moist wound healing during the past 2 weeks prior to inclusion * Adequate compression therapy during the past 2 weeks prior to inclusion * The patient is cognitive capable of evaluating his/her pain relief and pain intensity * The patient is able to understand the treatment and is willing to comply with the treatment regimen. * The patient is able to complete the patient diary * The patient is willing and able to give written informed consent
Exclusion criteria
* Painful ulcers that have been treatment resistant to analgesics for the past 6 months or more * Pregnant or lactating women * Known and verified hypersensitivity to any content of the products used in this investigation * Local infection (bacterial imbalanced wound) in the study ulcer * Clinical infection in the study ulcer * Diseases: Vasculitis, erysipelas and cellulitis of the peri-ulcer skin * The investigator considers the patient not eligible * Diseases and conditions where ibuprofen or other analgesics are contraindicated (including known hypersensitivity to Aspirin (acetylsalicylic acid) or other analgesics, especially associated with a history of asthma, rhinitis or urticaria) * Diabetes * Use of per need medication for the past 3 days * Concomitant treatment with systemic antibiotics other than nitrofurantoin * Concomitant treatment with systemic corticosteroids (more than 10 mg/day prednisolon or equivalent) or other immunosuppressants within 1 month prior to inclusion * Concomitant treatment with cancer chemotherapeutics * Concomitant participation in other studies * Previous participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Relief | Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning) | The distribution of pain relief assesment during day 1 to 5. The pain relief was registrated on 5-point verbal rating scales (evening/morning) from day 1 to day 5 after start of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity (PI) Change | Change from baseline in Pain Intensity (PI) on day 4 evening | Pain intensity (PI) assesment performed daily during the days 1-5. Pain intensity assesment performed on a 11 point numerical box scale: 0 was no pain and 10 was worst possible pain. A positive outcome measure value (PI (baseline) - PI (day 4 evening)) means that PI has decreased since baseline and thus reflects clinical improvement (patients suffer less from pain). |
| Change From Baseline in Ulcer Area | Change from baseline to end of trial (day 43) | Relative change from baseline in ulcer area using last observation carried forward. A positive outcome value Means that wound size has decreased and thus reflects wound healing (clinical improvement) |
| Adverse Events | Continuously from start of treatment to end of trial (day 43) | Number of Adverse events reported which were evaluated to be related or possible related to the device |
Countries
Denmark, France, Germany, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Biatain Ibu Biatain foam dressing containing ibuprofen | 60 |
| Biatain Biatain foam dressing without ibuprofen - control | 60 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 8 | 7 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Other reason | 1 | 0 |
| Overall Study | ulcer healed | 1 | 7 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Biatain Ibu | Biatain | Total |
|---|---|---|---|
| Age, Continuous Age | 71.6 YEARS STANDARD_DEVIATION 12.8 | 69.5 YEARS STANDARD_DEVIATION 12.5 | 70.6 YEARS STANDARD_DEVIATION 12.7 |
| Region of Enrollment Denmark | 32 participants | 32 participants | 64 participants |
| Region of Enrollment France | 3 participants | 3 participants | 6 participants |
| Region of Enrollment Germany | 22 participants | 22 participants | 44 participants |
| Region of Enrollment Spain | 3 participants | 3 participants | 6 participants |
| Sex: Female, Male Female | 42 Participants | 40 Participants | 82 Participants |
| Sex: Female, Male Male | 18 Participants | 20 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 60 | 6 / 60 |
| serious Total, serious adverse events | 0 / 60 | 1 / 60 |
Outcome results
Primary
Pain Relief
The distribution of pain relief assesment during day 1 to 5. The pain relief was registrated on 5-point verbal rating scales (evening/morning) from day 1 to day 5 after start of treatment.
Time frame: Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning)
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Biatain Ibu | Pain Relief | Slight Pain Relief | 26 percentage of scores within category |
| Biatain Ibu | Pain Relief | A lot Pain Relief | 19 percentage of scores within category |
| Biatain Ibu | Pain Relief | Moderate Pain Relief | 30 percentage of scores within category |
| Biatain Ibu | Pain Relief | Complete Pain Relief | 3 percentage of scores within category |
| Biatain Ibu | Pain Relief | No Pain Relief | 22 percentage of scores within category |
| Biatain | Pain Relief | Complete Pain Relief | 1 percentage of scores within category |
| Biatain | Pain Relief | No Pain Relief | 31 percentage of scores within category |
| Biatain | Pain Relief | Slight Pain Relief | 31 percentage of scores within category |
| Biatain | Pain Relief | Moderate Pain Relief | 26 percentage of scores within category |
| Biatain | Pain Relief | A lot Pain Relief | 11 percentage of scores within category |
Comparison: The null hypothesis to be tested was that the distributions of categorical responses were the same.p-value: 0.043895% CI: [1.02, 2.96]Chi-squared
Secondary
Adverse Events
Number of Adverse events reported which were evaluated to be related or possible related to the device
Time frame: Continuously from start of treatment to end of trial (day 43)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Biatain Ibu | Adverse Events | 4 Number of AE |
| Biatain | Adverse Events | 6 Number of AE |
Secondary
Change From Baseline in Ulcer Area
Relative change from baseline in ulcer area using last observation carried forward. A positive outcome value Means that wound size has decreased and thus reflects wound healing (clinical improvement)
Time frame: Change from baseline to end of trial (day 43)
Population: ITT population
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Biatain Ibu | Change From Baseline in Ulcer Area | 59 Relative change from baseline in percent | Standard Deviation 82 |
| Biatain | Change From Baseline in Ulcer Area | 50 Relative change from baseline in percent | Standard Deviation 60 |
Secondary
Pain Intensity (PI) Change
Pain intensity (PI) assesment performed daily during the days 1-5. Pain intensity assesment performed on a 11 point numerical box scale: 0 was no pain and 10 was worst possible pain. A positive outcome measure value (PI (baseline) - PI (day 4 evening)) means that PI has decreased since baseline and thus reflects clinical improvement (patients suffer less from pain).
Time frame: Change from baseline in Pain Intensity (PI) on day 4 evening
Population: PP-population (The PP population consisted of all randomized subjects that fulfilled the inclusion/exclusion criteria and which did not violate the protocol in a serious way day 1-5) - Evaluation performed on un-blinded data before database lock.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biatain Ibu | Pain Intensity (PI) Change | 2.2 Change in PI since baseline | Standard Deviation 2.2 |
| Biatain | Pain Intensity (PI) Change | 1.9 Change in PI since baseline | Standard Deviation 2.4 |