Evaluation of a muscle pump-activating device for non-healing venous leg ulcers

Connie Harris, Rochelle Duong, Gwen Vanderheyden, Beth Byrnes, Renee Cattryse, Ava Orr, David Keast, Connie Harris, Rochelle Duong, Gwen Vanderheyden, Beth Byrnes, Renee Cattryse, Ava Orr, David Keast

Abstract

This evaluation involves an innovative muscle pump-activating device (geko™) as an adjunctive therapy with best practices for non-healing venous leg ulcers (VLUs). Stimulating the common peroneal nerve (at the fibular head), the geko™ device creates a response that acts as foot and calf muscle pumps, increasing venous, arterial and microcirculatory flow. The aim was to evaluate and determine if the geko™ is effective in this population and if it should be added to the medical supply formulary. In all, 12 patients with 18 recalcitrant VLUs (defined as less than 30% reduction in wound size in 30 days with best practices) in two community settings in Ontario consented to the evaluation and were treated with the geko™ for up to 20 weeks. A total of 44% of wounds healed, and 39% decreased in size. One patient non-adherent with the geko™ and best practices had deterioration in his or her wounds. With the patients as their own control, the mean weekly healing rate with the geko™ was 9·35% (±SD 0·10) compared to 0·06% (±SD 0·10) prior to baseline, which was statistically significant (P < 0·01). Three patients not in optimal therapy increased compression due to decreased pain, further enabling healing. This study was not a randomised investigation, although the patients acted as their own controls. A pragmatic evaluation reflects the reality of the community sector; in spite of best practices or evidence-based care, therapy is not uniformly applied, with some participants unable to tolerate or indeed comply with optimal compression therapy. Rash occurred under the devices in 7 of 12 (58%) patients. One patient stopped the device due to rash, while another had to take breaks from using the device. Subsequently, the manufacturer (FirstKind Ltd) has developed a new device and protocol specific to the requirements of wound therapy to minimise this response. This small case series demonstrated the highly significant effectiveness of the geko™ device in these hard-to-heal VLUs. Further evaluations to determine dose and patient selection criteria are underway.

Keywords: Blood flow; Geko; Muscle pump activator; Non-healing venous leg ulcer.

© 2017 The Authors. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
geko™ device.
Figure 2
Figure 2
Anterior muscle engagement.
Figure 3
Figure 3
Lateral muscle engagement.
Figure 4
Figure 4
Electronic data collection.
Figure 5
Figure 5
Quality of life (QoL) screen.
Figure 6
Figure 6
Healing rate per week.
Figure 7
Figure 7
Cumulative proportion healed (all patients).
Figure 8
Figure 8
Ulcer healing rates. All patients with geko™ (ulcer healing status through 20 weeks).
Figure 9
Figure 9
(A) Patient 1 right foot at baseline. (B) Right leg at baseline. (C) Both healed at 5 weeks.
Figure 10
Figure 10
(A) Patient 2 fibrin‐covered wounds at baseline. (B) Wounds at 12 weeks.

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Source: PubMed

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