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

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.

Wearable Electrical Stimulation to Improve Lymphatic Function

“…Functional electrical stimulation (FES) has been advocated as a means to stimulate venous flow. It has been demonstrated as an effective intervention for managing the risk of venous thromboembolism (VTE) [6][7][8], aiding the healing of venous leg ulcers (VLUs) [9] and it is a feasible option for managing postoperative oedema [10]. Despite the evidence of FES as an effective method of promoting fluid transport, there has been limited research on the use of stimulation on individuals with lymphoedema.…”

Using a muscle pump activator device to stimulate healing for non‐healing lower leg wounds in long‐term care residents

“…In four Canadian evaluations to determine the effect of the MPA device as an adjunctive therapy to usual best practices with non‐healing venous leg ulcers (VLUs), 24 patients had a combined 140+‐year history of wounds. Seventeen patients who were adherent to best practice treatment and use of the MPA device had a reduction of surface area (SA) of 8.3%/week, which would be considered a “Normal” healing trajectory over 4 weeks in newly admitted patients .…”

“…Seventeen patients who were adherent to best practice treatment and use of the MPA device had a reduction of surface area (SA) of 8.3%/week, which would be considered a “Normal” healing trajectory over 4 weeks in newly admitted patients . In two evaluations, where the length of stay and initial wound measurements were available, the healing rate prior to the MPA device implementation was a 0.06% reduction in SA per week, compared with a 9.35% reduction per week with the MPA device ( P < 0.01) …”

“…14 of importance in LTC, where 11% of residents have congestive heart failure and 12% have atherosclerotic heart disease, 14 use of the MPA device increases the coronary blood flow in unstenosed vessels, 15 without increasing either heart rate 12 or affecting systemic blood pressure. 12,16 In four Canadian evaluations to determine the effect of the MPA device as an adjunctive therapy to usual best practices with non-healing venous leg ulcers (VLUs), 17,18 24 patients had a combined 140+-year history of wounds. Seventeen patients who were adherent to best practice treatment and use of the MPA device had a reduction of surface area (SA) of 8.3%/week, which would be considered a "Normal" healing trajectory over 4 weeks in newly admitted patients.…”

“…19 In two evaluations, where the length of stay and initial wound measurements were available, the healing rate prior to the MPA device implementation was a 0.06% reduction in SA per week, compared with a 9.35% reduction per week with the MPA device (P < 0.01). 18 At the same time, Revera, an LTC provider in Canada committed to helping seniors' live life to the fullest, created an Innovators in Aging programme 20 as a platform to invest in and scale innovations to improve the aging experience. By establishing pilot programmes in one or more homes, they could determine the role a product would have in:…”