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Sky Medical Technology Ltd Welcomes Publication of Compelling Evidence Demonstrating Cost-Effectiveness of the geko® Device for Venous Leg Ulcer Treatment in a Healthcare Setting
Key findings from the study, published in the International Wound Journal (IWJ), demonstrate that the geko device significantly enhances treatment outcomes by stimulating the common peroneal nerve, which increases venous, arterial, and microvascular blood flow. This physiological benefit translates into a remarkable increase in wound healing compared to SoC alone.
From an economic perspective, integration of the geko device into SoC protocols offers substantial cost savings. The study concluded that using the geko device results in an average cost saving of per patient, compared to SoC alone across the NHS.
Furthermore, economic analyses indicate that adopting the geko device reduces overall NHS average expenditure on venous leg ulcer wound management by per patient. The approach also positively impacts patients' health-related quality of life, making it a cost-effective adjunctive therapy for managing chronic venous leg ulcers within the NHS.
Fiona Young , Firstkind Wound Care Business Director, comments:
Also commenting, Bernard Ross Sky Founder and CEO said: "
The geko device is a neuromuscular electro-stimulator (NMES) designed for non-invasive use. It is applied to the skin's surface on the lateral aspect of the leg below the knee and over the head of the fibula. The device delivers a balanced electrical pulse to the common peroneal nerve, inducing dorsiflexion of the foot, which activates the venous calf and foot muscle pumps, thereby enhancing venous, arterial and microvascular blood flow. www.gekodevices.com
The - 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 hours per day alongside SoC, compared to WMA during a four-week period where the patient received SoC only.
The 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 Wound Margin Advance (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 study. The geko device was also reported as well tolerated with 94% patient concordance.
Conducted primarily within community services and outpatient leg ulcer clinics, the research encompassed a partitioned survival model based on a two-arm randomised controlled trial, assessing wound healing rates using Kaplan–Meier curves and parametric extrapolations, over a 12-month period. Costs were derived from UK reference costs, the British National Formulary, and the Personal Social Services Research Unit (2021/22). The primary outcome measured was the incremental cost per quality-adjusted life-year gained.
Sky Medical Technology Ltd, parent company of Firstkind Ltd, is a pioneering medical devices manufacturer focused on developing innovative solutions to improve patient outcomes and reduce healthcare costs. The company's flagship product, the geko device, is an advanced neuromuscular electro-stimulator designed to enhance blood flow to address a range of medical conditions. Conditions of focus include accelerated chronic wound healing, thrombosis prevention, and the management of trauma-based and pre- and post-operative swelling. Sky Medical Technology Ltd is dedicated to advancing healthcare through cutting-edge research and product development. www.gekodevices.com
For access to the cost-effective study click: https://onlinelibrary.wiley.com/doi/10.1111/iwj.70048
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