Oedema Management with geko following Foot and Ankle Surgery
Research type
Research Study
Full title
Postoperative Oedema Management of Foot and Ankle Patients with Neuromuscular Electro-stimulation of the Peroneal Nerve using geko™
IRAS ID
300770
Contact name
Shelain Patel
Contact email
Sponsor organisation
Firstkind Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Summary of Research
Having some leg swelling is a normal part of the healing process following foot or ankle surgery. This swelling is often caused by a build-up of fluid in the area where surgery has taken place and is called oedema. Oedema can be painful and slow down patient recovery post surgery. The standard care patients receive from hospital after surgery consists of treatments used within the NHS to help prevent and reduce oedema formation and aid recovery e.g. keeping leg raised Another treatment which may also help to prevent and reduce oedema formation after foot and ankle surgery is treatment with a medical device called the geko™ device. The geko™ device is a CE marked medical device which means the manufacturer has checked that the device complies with the essential safety and performance requirements for its’ intended use which is to increase blood circulation and prevent and treat oedema. Following the consent process patients who have had foot and or ankle surgery will receive one of two treatments, either standard or standard care with the addition of treatment with the geko™ device for 12 hours / day for approximately 14 days. There will be 3 follow-up visits which will take place round about 2 weeks, 6 weeks and 12 weeks post-surgery.
The primary objective of the study is to assess oedema formation with and without geko™ therapy on patient outcomes during the follow-up period of up to three months post-surgery to identify which treatment will provide the best clinical outcome for patientsSummary of Results
This study evaluated the addition of the geko® muscle-stimulating device to standard postoperative
care following forefoot and/or hindfoot surgery Objectives To determine whether using the geko®
care following forefoot and/or hindfoot surgery. Objectives To determine whether using the geko®
device alongside standard care reduces postoperative swelling (oedema) more effectively than standard
care alone. To assess whether the device supports faster wound healing. To confirm the safety and
tolerability of the geko® device in this patient population. Methods Swelling measurement: We
compared the circumference of the operated leg with the non-operated leg to calculate an oedema
ratio. Wound healing assessment: We recorded the number of patients whose surgical wounds were
fully healed by 14 days after surgery. Leg recovery measurement: We used a “figure-of-eight” (Fo8)
tape measurement around the foot and ankle to assess restoration toward pre-surgery size. Safety and
patient comfort: We monitored adverse events (AEs) and collected patient-reported pain scores (Visual
Analogue Scale, VAS) and foot-function questionnaires (Manchester Oxford Foot Questionnaire,
MOxFQ). Key Findings Significant reduction in swelling At 14 days post-surgery, the oedema ratio was
significantly lower in the group receiving geko® plus standard care versus standard care alone. The
strongest statistical significance was observed in the Spanish cohort (p = 0.007), with a consistent trend
when combining data from Spain and the UK (p = 0.02). Improved leg circumference recovery The
percentage increase in Fo8 measurement from baseline to Day 14 was significantly less in the geko®
group, indicating more rapid return to normal leg size. Enhanced wound healing A higher proportion of
wounds were fully healed, and fewer wounds exhibited delayed healing in the geko® group compared
to standard care only. Sub-analysis of patients undergoing bunion (hallux valgus) surgery confirmed a
significant reduction in swelling with geko® use (p < 0.05). Safety and tolerability No device-related
safety concerns or serious adverse events were reported. Pain scores (VAS) and patient-reported foot
function (MOxFQ) were similar between both groups, indicating that the geko® device did not
introduce any additional discomfort. Conclusion The addition of the geko® muscle-stimulating device
to standard postoperative care demonstrates clear benefits in reducing swelling, promoting faster
wound healing, and supporting overall recovery after forefoot and/or hindfoot surgery. The device was
well tolerated, with no new safety issues identified. These results endorse the geko® device as a
valuable adjunct therapy in this clinical setting.REC name
West of Scotland REC 4
REC reference
21/WS/0099
Date of REC Opinion
5 Nov 2021
REC opinion
Further Information Favourable Opinion