ArticleTrials2023
Compression therapies for the treatment of venous leg ulcers: study protocol for a process evaluation in a randomised controlled trial, VenUS 6.
Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed.
- Trial
- Smart Bandage Based on Batteryless NFC for Wireless Pressure and Wound State Monitoring.Biosensors · 2026Article
- Functional electrospun nanofibers: fabrication, properties, and applications in wound-healing process.RSC advances · 2024Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
backgroundThe VenUS 6 parallel-group randomised controlled trial (RCT) will compare the clinical and cost-effectiveness of compression wraps, two-layer compression bandage and evidence-based compression therapy, comprising of two-layers of hosiery or four-layer bandages, for healing time of venous leg ulcers. We will conduct an embedded process evaluation to evaluate the implementation of the trial and the various compression therapies and to gain a more in-depth understanding of trial participant and nursing staff views and experiences of these therapies.
methodsThis process evaluation will be a mixed-method study, embedded into a wider RCT. Qualitative data will be collected through semi-structured individual in-depth interviews with trial participants and staff members. Quantitative data will be collected using patient questionnaires and case report forms that are part of the main trial data collection process. Interview transcripts will be analysed using the Framework Analysis and interview data will be integrated with quantitative RCT data using the RE-AIM framework and the Pillar Integration Process. DISCUSSION: We describe the protocol for a process evaluation, designed to assess the implementation of the various venous leg ulcer compression therapies as evaluated in VenUS6, and the experiences of trial participants and nursing staff using these. This protocol provides one example of how an embedded mixed-method process evaluation can be conducted.
trial registrationISRCTN 67321719 ( https://doi.org/10.1186/ISRCTN67321719 ). Prospectively registered on 14 September 2020. Recruitment Infographic SWAT-MRC Hub for Trials Methodology Research SWAT repository #116. Registered on 13 April 2020. Retention Thank You Card SWAT-MRC Hub for Trials Methodology Research SWAT repository #119. Registered on 13 April 2020. Retention Newsletter SWAT-MRC Hub for Trials Methodology Research SWAT repository #28. Registered on 01 July 2007. Retention Pen SWAT-MRC Hub for Trials Methodology Research SWAT repository #92. Registered on 01 April 2019. PROTOCOL VERSION: V1.5, 26 May 2022.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.