Foot and Ankle Post-operative Oedema Management Using Geko™

Surgery Clinical Trial

Official title:

Postoperative Oedema Management of Foot and Ankle Patients With Neuromuscular Electro-stimulation of the Peroneal Nerve Using Geko™

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04927234
• Other study ID #: FSK-F&A-001
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2022
• Est. completion date: September 2024

Study information

• Verified date: August 2023
• Source: Firstkind Ltd
• Contact: Kieron Day, DPhil
• Phone: +44 (0) 7921 106253
• Email: Kieron.Day[@]firstkindmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The multicentre randomised geko™ Foot and Ankle Trial will prospectively and systematically collect clinical data on patients randomised, on a 1:1 basis, to either standard care or standard care plus geko™ therapy to assess oedema management and patient outcomes during a follow-up period of up to three months post-surgery.

Description:

The geko™ device has a wide range of clinical applications including the post-operative management of oedema.

Although many short-term acute studies have been completed using the device, little clinical data has been collected on the effect of geko™ use in current standard care pathways for oedema management on patient outcomes during long term follow-up after surgery.

This study is an open label, multi-centre prospective randomised study. The study patient population will be randomised on a 1:1 basis into two groups of 61 patients each. These groups are defined as Group A patients who receive geko™ therapy and SC i.e. the intervention group and Group B patients who receive Standard Care (SC) only i.e. no intervention. The participants will be assessed pre-surgery and up to 90 days post-surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged = 18 years

• Intact healthy skin at the site of geko™ device application.

• Patients that have been listed for forefoot and / or hindfoot surgery

• Patient understands and is willing to participate in the study and can comply with study procedures

• Patient is willing and able to give written informed consent

Exclusion Criteria:

• Pregnant

• Use of any other neuro-modulation device.

• Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.

• No response to geko™ therapy i.e. no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting

• Participation in any other clinical study that may interfere with the outcome of either study

Related Conditions & MeSH terms

• Edema
• Surgery

Intervention

Device:
• geko™ therapy
Neuro-muscular electrical stimulation of the peroneal nerve

Locations

Country	Name	City	State
Spain	Hospital Clinic Barcelona	Barcelona
Spain	Hospital Universitario Vall d'Hebron	Barcelona
United Kingdom	The Royal National Orthopaedic Hospital NHS Trust	Stanmore
United Kingdom	Maidstone and Tunbridge Wells NHS Trust	Tunbridge Wells
United States	Golden State Orthopedics and Spine	Capitola	California

Sponsors (1)

Lead Sponsor	Collaborator
Firstkind Ltd

Countries where clinical trial is conducted

United States,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of post-operative oedema formation using the figure-of-eight tape measurement	To assess the effect of geko™ therapy on oedema formation following foot and / or ankle surgery. This will be done using the figure of eight tape measurement method	From pre-surgery assessment until up to 90 days post-surgery
Primary	Assessment of post-operative oedema formation using the pitting oedema scale	To assess the effect of geko™ therapy on oedema formation following foot and / or ankle surgery using the pitting oedema scale, where following a 2 second firm thumb press, 0 (min) indicates no oedema and 4 (max) is a very deep pit.	From pre-surgery assessment until up to 90 days post-surgery
Primary	Assessment of post-operative oedema formation using bioimpedance analysis (US sites only)	To assess the effect of geko™ therapy on oedema formation following foot and / or ankle surgery using a bioimpedance device to measure resistance to electrical current in both legs and calculating the percentage difference between the operated leg and the contralateral limb.	From pre-surgery assessment until up to 90 days post-surgery
Secondary	Incidence of Adverse Events in each group		From pre-surgery assessment until up to 90 days post-surgery
Secondary	Incidence of device deficiencies	To assess the number of geko device deficiencies (if any)	from start of geko treatment (immediately post-surgery) until up to 90 days post-surgery
Secondary	Change in pain level using a visual analogue scale (VAS) score	Assessing pain levels using a visual analogue scale (VAS) score, where 0 means no pain and 100 is the worst pain possible.	From pre-surgery assessment until up to 90 days post-surgery
Secondary	Incidence of surgical wound healing	Visually assessing the surgical wound healing status as either healed/progressing/static/deteriorating/severe.	From surgery until up to 90 days post-surgery
Secondary	Change in analgesia dosage	Assessing changes in dosage of recorded analgesic medication taken by the patient	From pre-surgery assessment until up to 90 days post-surgery
Secondary	Change in analgesia frequency	Assessing changes of frequency of recorded analgesic medication taken by the patient	From pre-surgery assessment until up to 90 days post-surgery
Secondary	Change in patient reported outcomes via Manchester-Oxford Foot & Ankle Questionnaire (MOxFQ)	Domains that are assessed in this questionnaire include walking/standing, pain and social interaction. Scores will range from 0 to 100, where 100 is most severe.	From pre-surgery assessment until up to 90 days post-surgery

External Links

•   Device official website