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

  shelain.patel@nhs.net

• Sponsor organisation

  Firstkind Ltd

• Clinicaltrials.gov Identifier

  NCT04927234

• Duration of Study in the UK

  1 years, 6 months, 1 days

• Research summary

  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 patients

• 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