N/A
Completed N=120
Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers
Leg Ulcers
Source: ClinicalTrials.gov NCT00627094 ↗
Enrolled (actual)
120
Serious AEs
0.8%
Results posted
Feb 2017
Primary outcomePrimary: Pain Relief — 22; 31; 26; 31 percentage of scores within category — p=0.0438
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Relief |
22; 31; 26; 31; 30; 26 | 0.0438 sig |
| SECONDARY Pain Intensity (PI) Change |
2.2; 1.9 | — |
| SECONDARY Change From Baseline in Ulcer Area |
59; 50 | — |
| SECONDARY Adverse Events |
4; 6 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00627094). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.