Sky’s Geko Device Evaluated for Healing Venous Leg Ulcers

March 29, 2023—Sky Medical Technology, a United Kingdom–based medical device manufacturer, announced the publication of the company’s landmark multicenter randomized self-controlled trial that compared standard of care (SoC) with and without the company’s Geko device in patients with hard-to-heal venous leg ulcers (VLUs). The study, in which patients acted as their own controls, demonstrated an acceleration in the rate of healing by more than double in patients treated with the Geko neuromuscular electrostimulation device versus SoC alone.

The findings from Efficacy Study for Geko Device in VLU Patients were published by Richard Hillson Bull et al in International Wound Journal.

According to the company, Geko is a small, self-adhesive, wearable device that is applied to the surface of the skin below the knee, over the head of the fibula bone. It delivers one gentle electrical pulse 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.

The study’s primary efficacy endpoint was a comparison of the rate of wound margin advance (WMA), a predictor of wound healing, during a 4-week treatment period where the Geko device was worn for 12 hours per day alongside SoC, compared to WMA during a 4-week period where the patient received SoC only.

The study results showed that adding the Geko device alongside SoC led to a statistically significant twofold acceleration in the rate of VLU healing (P = .016), as measured by WMA, compared to a 4-week period of compression alone. Analysis of the percentage area reduction also showed a twofold acceleration in the rate of healing (P = .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 to be well tolerated with 94% patient concordance.

Patients receiving the Geko device also reported better outcomes in pain reduction, plausibly reflected in the accelerated reduction in wound size. Patients randomized to Geko were also more likely to heal completely at the 12-week follow-up than those randomized to SoC alone.

The company also noted that the study continued throughout the pandemic, despite COVID-19 protocols, indicating the ease and simplicity of the treatment.

“As a clinician in wound care, especially when managing patients with chronic wounds, the ultimate goal is improvement in healing rates,” commented study investigator Agnes Juguilon Collarte in the company’s press release. “The results of this randomized self-controlled trial are extremely impressive and are also borne out in our direct experience of real-world use.”

Collarte, Tissue Viability Specialist Nurse Lead at Inner Northwest Division, St Charles Center for Health & Wellbeing in London, United Kingdom, continued, “Nonhealing VLUs stop patients living their lives and rob them of hope. The Geko device consistently accelerates VLU healing in the patients I treat.”