ArticleInternational wound journal2023
The impact of a new intervention for venous leg ulcers: A within-patient controlled trial.
Article in International wound journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03396731 (A Prospective, Multicentre, Randomised, Assessor Blinded Study Comparing the Efficacy, Including Patient Reported Outcomes of Two Different Daily gekoTM Treatment Durations in Conjunction With Standard Care, With Each Other and to Standard Care Alone, in Patients With Venous Leg Ulcers), which is not on this map. Cited by 10 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
A Prospective, Multicentre, Randomised, Assessor Blinded Study Comparing the Efficacy, Including Patient Reported Outcomes of Two Different Daily gekoTM Treatment Durations in Conjunction With Standard Care, With Each Other and to Standard Care Alone, in Patients With Venous Leg Ulcers
Who cites it
10 citing papers in PubMed, 14 citations in OpenAlex.
- Cost Effectiveness of Venous Leg Ulcer Healing Using Muscle Pump Activation.International wound journal · 2026Trial
- Cost-effectiveness analysis of the geko™ device (an NMES technology) in managing venous leg ulcers in UK healthcare settings.International wound journal · 2024Trial
- Neuromuscular Stimulation of the Common Peroneal Nerve: Improved Pain Trajectory in Chronic Venous Leg Ulcers.Journal of clinical medicine · 2026Article
- The Association of Systemic Inflammation, Wound Bioburden and Total Bacterial Counts With Healing Outcomes in Older Adults With Chronic Venous Leg Ulcers.International wound journal · 2025Article
- Healing Rate and Time to Closure of Venous Leg Ulcers: A Real-World Service Evaluation of Neuromuscular Electrostimulation as an Adjunct to Compression Therapy.Advances in skin & wound care · 2025Article
- Canadian Consensus Statement for the Management of Venous Leg Ulcers.International wound journal · 2025Article
- Continuous muscle pump activation by neuromuscular electrical stimulation of the common peroneal nerve in the treatment of patients with venous leg ulcers: A position paper.International wound journal · 2024Review
- The muscle pump activator device: From evidence to lived experiences.International wound journal · 2024Review
- A Novel Randomized Trial Protocol for Evaluating Wound Healing Interventions.Advances in wound care · 2023Article
- The impact of a new intervention for venous leg ulcers: A within-patient controlled trial.International wound journal · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 4 institutions in 1 country.
Funding
Abstract
A major obstacle to the development of new treatments for venous leg ulcers is the difficulty in generating evidence for their effectiveness. Randomised controlled trials using complete healing as the endpoint are seldom powered to be successful, owing to the heterogeneity of cohorts. A novel approach to the evaluation of treatments is presented, using a self-controlled trial model and two metrics of short-term healing rate as alternate endpoints: rate of wound margin advance, and percentage area reduction over 4 weeks. Two different treatment regimens are compared: multi-layer compression alone, versus multi-layer compression combined with activation of the venous leg pump by neuromuscular stimulation. With 60 patients, adding neuromuscular stimulation to multilayer compression resulted in a significant two-fold increase in the rate of wound healing over a 4-week period, both in terms of wound margin advance and in terms of percentage area reduction. The use of these short-term intermediate endpoint metrics together with a self-controlled study design offers potential for distinguishing between the relative efficacies of interventions more rapidly, with greater sensitivity, and with fewer subjects than a conventional RCT cohort model.
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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.