An adaptive clinical trial of topical, anti-inflammatory dressings on pain in adults with venous leg ulcers: Pilot study
An adaptive clinical trial of topical anti-inflammatory agents on pain in patients with venous leg ulcers: A Sequential Multiple Assignment Randomised Trial - Pilot study
Queensland University of Technology
30 participants
Aug 30, 2018
Interventional
Conditions
Summary
SYNOPSIS Study Title: An adaptive trial of topical anti-inflammatory agents on pain in patients with chronic venous leg ulcers: A Sequential Multiple Assignment Randomised Trial - Pilot study Development Phase: IV, Pilot Study Purpose: The primary purpose of this study is to evaluate the effectiveness of an anti-inflammatory wound dressing, containing ibuprofen, on pain levels of patients with chronic venous leg ulcers. The primary hypothesis is that this ibuprofen-impregnated wound dressing will result in reduced levels of pain, in comparison to a non-medicated dressing. Indication: Pain score of 3 or more on the Numerical Rating Scale (0-10) in patients with venous leg ulcers Study Therapy: Group 1- Ibuprofen impregnated foam dressing, compared to a non-medicated foam dressing. Group 2 – Activated Carbon dressing. A pragmatic adaptive multiple allocation trial design will evaluate an antimicrobial and anti-inflammatory activated carbon dressing for participants who fail to respond, i.e. whose pain scores do note reduce by 3 or more on a 0-10 rating scale; to the ibuprofen dressing. Study Population: Male and female adults with chronic venous leg ulcers (present for 4 weeks or more) and who fit with the study inclusion/exclusion criteria will be recruited into the study. For this pilot study, 30 study participants will be recruited. No. Centres: Queensland University of Technology; Royal Brisbane & Women’s Hospital; Holy Spirit Northside Private Hospital Study Design: The study has a Sequential Multiple Assignment Randomised Trial design. Study Duration: Total of 4 weeks Objectives of the Study: This pilot study aims to obtain preliminary evidence on the effectiveness of two anti-inflammatory wound dressings on pain in patients with chronic venous leg ulcers. A sequential, multiple allocation randomised controlled trial of an ibuprofen-impregnated foam dressing, or an activated carbon dressing for non-responders, will be compared with a non-medicated foam dressing. Study Endpoints: (Primary and Secondary) The primary outcomes of this pilot Sequential Multiple Assignment Randomised Trial is to obtain preliminary evidence on the effectiveness of two anti-inflammatory wound dressings on pain in patients with chronic venous leg ulcers. Secondary outcomes include obtaining evidence on the feasibility of the study and variation in outcome measures, to guide future applications for a fully powered trial. The primary safety endpoints will be incidence of treatment emergent adverse events with study participants assessed prior to commencing the trial and then again following every week for adverse effects.
Eligibility
Inclusion Criteria5
- patients with leg ulcers of primarily venous aetiology present for at least 4 weeks
- Ankle Brachial Pressure Index equal to or more than 0.8, and < 1.3.
- ulcer size at least 2cm2 , with exudate present
- able to understand to give consent
- patients report a pain score of at least 3 on a Numerical Rating Scale of 0 – 10
Exclusion Criteria5
- Patients with a leg ulcer of non-venous aetiology (e.g. arterial, diabetic, malignancy, or other causes).
- Patients with clinical signs of wound infection
- Patients prescribed oral NSAIDs
- Patients with contradictions for NSAID use (i.e. renal disease, gastrointestinal bleeding, clotting disorders, and asthma)
- Patients with cognitive impairment
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Interventions
This Sequential Multiple Assignment Randomised Trial design will assess the effectiveness of an ibuprofen foam wound dressing plus standard care; and an activated carbon dressing (2nd intervention for non-responders to first intervention) in participants with venous leg ulcers. This design is an adaptive intervention approach. The dressings will be administered once/week for 4 weeks during normal wound dressing change appointments by the patient's routine clinician in charge of care. As the dressings will be applied underneath compression therapy (standard care for venous leg ulcers), which should remain in place for a week, the return of the patient with the dressing and compression therapy still in place will indicate adherence to the intervention. This pilot study will have a four-week treatment assessment period including two stages. In Stage 1, intervention patients will receive an ibuprofen-impregnated foam dressing (Biatain® Ibu) plus standard care. The dressings are manufactured by Coloplast, who produce a foam dressing with the addition of 0.5 mg/cm2 of ibuprofen dispersed throughout the foam, Biatain® Ibu. In Stage 2, participants who do not respond to the ibuprofen dressing (i.e. do not achieve = a decrease of 3 on the NRS for pain), will commence a one week wash-out phase with a non-medicated foam dressings, then start treatment with an activated carbon cloth dressing (Zorflex®) plus standard care. Standard care is defined as comprehensive assessment, a non-adherent wound dressing (no specific dressing is recommended), and graduated compression therapy, as per the Australian evidence-based guidelines for venous leg ulcers (AWMA & NZWCS, Cambridge Publishing, 2011).
Locations(2)
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ACTRN12617001632381