29 Mar Our landmark RCT demonstrates double the rate of healing of venous leg ulcers with the geko™ device.
We are delighted to announce that the International Wound Journal (IWJ) has published our landmark multi-centre randomised self-controlled trial (RCT).
The study compares standard of care (SoC) with and without the geko™ device in patients with hard-to-heal venous leg ulcers (VLUs) and reports an acceleration in the rate of healing by more than double in patients treated with the geko™ device versus SoC alone. The results offer new hope to patients suffering long-standing chronic wounds.
The study is the first RCT to show a statistically significant increase in the rate of healing of VLUs treated with an advanced neuromuscular electrostimulation device (the geko™ device), adjunctive to standard of care.
“The results of this randomised self-controlled trial are extremely impressive and are also borne out in our direct experience of real-world use. Non-healing VLUs stop patients living their lives and robs them of hope. The geko™ device consistently accelerates VLU healing in the patients I treat.” comments Agnes Juguilon Collarte, Tissue Viability Specialist Nurse Lead, Inner Northwest Division (Central London, Hammersmith & Fulham and West London).
VLU burden
Approximately 3.8 million adults in the UK suffer with a wound4. Many are hard-to-heal and, despite following best practice, wound healing can be prolonged or often never achieved, with more than 50 percent of VLUs failing to heal in 12 months4. Patients experience pain, anxiety, altered body image and isolation, leaving many without hope of improvement, suffering wound infections and recurrence.
The financial burden of non-healing wounds on hard pressed healthcare systems is also huge, higher than for cancer and cardiovascular disease. The annual NHS cost to manage wounds is £8.3 billion annually, £5.6 billion of which is the management of wounds that fail to heal4. VLUs affect one in 500 adults in the UK and cost the NHS over £2 billion annually2,– a number that is set to rise5.
About the RCT
The study, a multi-centre self-controlled trial, randomised patients with hard-to-heal VLUs, each acting as their own control. The primary endpoint was a comparison of the rate of wound margin advance (WMA), a powerful predictor of wound healing, during a four-week treatment period where the geko™ device was worn for 12 hours per day alongside SoC, compared to WMA during a four-week period where the patient received SoC only.
The study results show that adding the geko™ device alongside SoC, led to a statistically significant two-fold acceleration in the rate of VLU healing (p=0.016), as measured by WMA compared to a 4-week period of compression alone. Analysis of the percentage area reduction (PAR) also showed a two-fold acceleration in the rate of healing (p=0.011), in contrast to compression alone, which maintained the same rate of healing throughout the run-in and treatment phases of the study1.
The geko™ device was also reported as well tolerated with 94 percent patient concordance1. Patients receiving the geko™ device reported better outcomes in pain reduction, plausibly reflected in the accelerated reduction in wound size1and were also more likely to heal completely at the 12-weeks follow-up, than those randomised to SoC alone1. It is also worth noting the study continued throughout the pandemic, despite new COVID-19 protocols, indicating the ease and simplicity of the treatment.
A hallmark of the study is the WMA and PAR metrics that allowed a self-controlled study model to distinguish between the relative efficacies of the treatment regimens more rapidly, with greater sensitivity and with fewer subjects than a conventional RCT cohort model. RCTs using complete healing as the endpoint are seldom powered to be successful, owing to patient clinical diversity under a study7. We believe the trial can be considered as a landmark study with its unparalleled effect size for a medical device.
The outstanding results are also pivotal to placing this much anticipated data into the hands of our fast-expanding network of UK tissue viability nurses (TVNs) and international wound care specialists, eager to embrace a transformative innovation that is able to increase the rate of healing.
Ideal for home use and easy to fit, the geko™ device provides a seamless addition to the current VLU pathway, empowering patients to both self-care, without disruption to daily routines, and to share-their-care with family members and healthcare professionals – reinforced by the high concordance rate of 94 percent reported in the study.
You can read the full RCT in the International Wound Journal here.
References
- Bull, RH, Clements, D, Collarte, AJ, Harding, KG. The impact of a new intervention for venous leg ulcers: A within-patient controlled trial. Int Wound J. 2023; 1- 9. doi:10.1111/iwj.14107
- https://www.nhs.uk/conditions/leg-ulcer/
- Phillips, CJ, Humphreys, I, Thayer, D, et al. Cost of managing patients with venous leg ulcers. Int Wound J. 2020; 17: 1074– 1082. https://doi.org/10.1111/iwj.13366
- Guest JF, Fuller GW, Vowden P. Cohort study evaluating the burden of wounds to the UK’s National Health Service in 2017/2018: update from 2012/2013. BMJ Open. 2020 Dec 22;10(12):e045253. doi: 10.1136/bmjopen-2020-045253. PMID: 33371051; PMCID: PMC7757484.
- Probst, S., Weller, C.D., Bobbink, P. et al.Prevalence and incidence of venous leg ulcers—a protocol for a systematic review. Syst Rev 10, 148 (2021). https://doi.org/10.1186/s13643-021-01697-3
- Tucker A, Maass A, Bain D, Chen LH, Azzam M, Dawson H, et al. Augmentation of venous, arterial and microvascular blood supply in the leg by isometric neuromuscular publication of the International College of Angiology, Inc. 2010 Spring; 19(1): e31-7.
- Godwin M, Ruhland L, Casson I, MacDonald S, Delva D, Birtwhistle R, Lam M, Seguin R. Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity. BMC Med Res Methodol. 2003 Dec 22;3:28. doi: 10.1186/1471-2288-3-28. PMID: 14690550; PMCID: PMC317298.
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