Treatment offers new hope for patients with long-standing
wounds
- Sky Medical Technology Ltd announces publication of a
multi-centre randomised self-controlled trial (RCT) in the
International Wound Journal.
- The study compared standard of care (SoC) with and without the
geko™ device in patients with hard-to-heal venous leg ulcers
(VLUs).
- Results show the geko™ device, combined with multi-layer
compression doubles the rate of healing vs. compression
alone1.
- The study is the first RCT to show a statistically significant
increase in the rate of healing in VLU patients treated with an
advanced adjunctive neuromuscular electrostimulation
device (geko™).
- VLUs affect one in 500 adults in the UK2, costing
the national healthcare system around £2 billion
annually3.
- Worn at the knee, the wearable geko™ device, a
neuromuscular electrostimulator, increases venous, arterial and
microcirculatory blood flow, transporting oxygenated blood to the
wound bed accelerating wound healing.
HIGH WYCOMBE, England, March 29,
2023 /PRNewswire/ -- UK-based medical device
manufacturer Sky Medical Technology (Sky) today announces the
International Wound Journal has published the company's landmark
multi-centre randomised self-controlled trial (RCT). The study
compared 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 study1 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.
"As a clinician in wound care, especially when managing
patients with chronic wounds, the ultimate goal is improvement in
healing rates. 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).
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% 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 costing the NHS over £2 billion annually2, 50%
of which remain unhealed4 – 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 efficacy 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
hrs per day alongside SoC, compared to WMA during a four week
period where the patient received SoC only.
The geko™ device is a small-in-size, self-adhesive, wearable
neuromuscular electro stimulator that is applied to the surface of
the skin just below the knee, over the head of the fibula bone. It
delivers a gentle electrical pulse, once per second to the common
peroneal nerve, activating the calf and foot muscle pumps,
increasing venous, arterial, and microvascular flow, effectively
replicating the effects of exercise.6
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%
patient concordance1.
Patients receiving the geko™ device also reported better
outcomes in pain reduction, plausibly reflected in the accelerated
reduction in wound size1. Patients randomised to
geko™ 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.
Commenting on the clinical trial, Kieron Day, Sky
Head of Clinical Studies, says: "We are extremely pleased
with the highly positive results and grateful for the efforts of
the clinical trial participants and investigators. 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. Overall, I believe this trial may be
considered to be a landmark study with an unparalleled effect size
for a medical device.
Fiona Young, Sky Wound Care
Business Director, comments: "These outstanding results are 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 able to increase the rate of healing.
Ideal for home use and easy to fit, the geko™ device is 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% reported in the
study."
Fiona adds: "The geko™ device is commercially available in
the UK with regulatory approval granted in a growing number of
international markets, with work to gain the necessary clearance to
access the North American market advancing. We encourage early
access to the geko™ device through our Partner-With-Us program.
Please follow this link for details and to contact
us."
Bernard Ross, Sky Medical
Technology's Founder and CEO, comments: "We are delighted to have
completed this landmark study which further validates geko™ device
effectiveness in reporting a doubling of the rate of VLU healing,
in a market that has seen surprisingly little real innovation in
SoC over 20 years. Gold standard multi-layer compression can be
effective, particularly in less complex and smaller wounds, but
even in these patents is too often associated with low patient
adherence. The success of the geko™ device in increasing the
rate of SoC VLU healing is a critical step in bringing MedTech
innovation to VLU patients around the world and to modernising
standard of care – and cements our commitment to the streamlining
of wound-care through evidence-based clinical efficiency for better
patient outcomes."
References
1. 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
2.
https://www.nhs.uk/conditions/leg-ulcer/
3. 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
4. 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.
5. 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
6. 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.
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.
About Sky Medical Technology Ltd
Sky Medical Technology (Sky) is a UK-based medical devices
company. Through its innovative mechanism of non-invasive
neuromuscular electrostimulation, Sky has developed a
ground-breaking NMES technology platform, OnPulse™, embedded in its
industry-leading product, the geko™ device. The company develops a
range of products tailored to the needs of different medical
application areas, selling both direct and through strategic
partnerships or distributors in each major clinical area. Clinical
areas of interest include chronic wound healing, the treatment and
prevention of oedema (swelling) and venous thromboembolism
prevention (VTE). The goal in each therapy area is to partner with
healthcare professionals to improve clinical outcomes and patient
care while at the same time reducing cost for health
systems.
www.gekodevices.com
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