Active not recruitingOBSERVATIONAL

Geko™ Cross Therapy Registry - Wound

This study, called the geko™ Cross Therapy Registry, is looking at how a device called geko™ helps people with different types of leg wounds, such as venous leg ulcers, diabetic foot ulcers, and arterial leg ulcers. It's not testing a new treatment, but rather collecting information about how the geko™ device is used in regular care. The main goal is to see how well the device works for patients over a longer period and to make sure it's safe and effective. Taking part involves having the geko™ device as part of your wound management and attending a few follow-up appointments to track your progress. This information helps healthcare providers understand the real-world benefits for people with complex wounds.

At a glance

Status

Active not recruiting

Sponsor

Firstkind Ltd

Enrolment target

2,500

Start

04 Apr 2022

Estimated completion

01 Mar 2028

Wound Venous Leg Ulcer Diabetic Foot Ulcer Arterial Leg Ulcer

What is this study about?

This study is called the geko™ Cross Therapy Registry - Wound. It's designed to collect information about how a small device, called geko™, helps people in the UK who have wounds on their lower legs, such as ulcers caused by poor circulation from veins or arteries, or related to diabetes.

This isn't a study where a new treatment is being tested. Instead, it's like a careful record-keeping project. The researchers want to observe and understand how the geko™ device is used in everyday care for managing wounds. By collecting information from many people, they can see how it works over time, what impact it has on healing, and if it helps improve patients' lives.

The information gathered will help show how well the geko™ device performs in the real world and ensure it continues to be a safe and effective option for wound care. This is important for both patients and for the rules that guide medical devices. Up to 50 hospitals or clinics around the world will be involved in collecting this important data.

Key takeaways

This study collects real-world information on the geko™ device for leg wounds.
It's not testing a new treatment, but observing current care.
Participation involves using the geko™ device and attending follow-up visits.
The aim is to understand how the device helps patients over time.
Information gathered supports the device's safety and effectiveness.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. You must have healthy skin where the geko™ device would be placed. You also need to have a wound on your lower leg that your doctor has decided would benefit from using the geko™ device as part of your regular treatment plan. It's important that you understand the study and are willing to give your written permission to take part.

There are some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, you cannot participate. If you are already using other nerve-stimulating devices (like TENS machines) in certain areas of your body, or if you have had a recent injury to your lower leg that would stop the geko™ device from working properly, you wouldn't be eligible. Also, if the geko™ device doesn't make your foot twitch slightly when it's on, even at its highest setting, you wouldn't be able to join.

Quick self-check

Are you 18 years old or older?
Do you have a leg wound (ulcer) for which your doctor recommends geko™ therapy?
Do you have healthy skin where the geko™ device would be placed?
Are you able to agree to take part in writing?
Are you NOT pregnant or breastfeeding?
Are you NOT currently using other similar nerve-stimulating devices (like TENS) on your legs or back?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would receive the geko™ device as part of your usual care for your leg wound. The researchers will gather information about your wound and how you are doing over time. This will involve an initial visit where you give your permission to join, and then up to four follow-up visits. These follow-up visits are important for tracking your progress and seeing how the geko™ device is working for you. The study aims to collect long-term information, so attending as many of these follow-up appointments as possible is helpful.

Potential risks and benefits

Taking part in this study means that your wound treatment will include the geko™ device, which your doctor believes will help. The main benefit is that your progress with the geko™ device will be carefully monitored, which can contribute to better understanding of its effectiveness. Since this device is already part of standard care, there are no new experimental risks introduced by joining the study. The main involvement is providing information and attending follow-up visits. You are free to withdraw from the study at any time without affecting your medical care.

Locations (3)

Northwell Health System
New York, United States
Central London Community Health Care NHS Trust
London, United Kingdom
Norfolk Community Health and Care NHS Trust
Norwich, United Kingdom

Common questions

What is the geko™ device?

The geko™ device is a small, gentle device that aims to help with leg wounds, often by improving blood flow or reducing swelling.

Is this a new medicine or a test treatment?

No, this study is not about a new medicine or an experimental treatment. It's observing how the geko™ device works in real life when used as part of regular care.

How many times will I need to visit?

After your initial visit, you might be asked to attend up to four follow-up visits to check on your progress.

Will I get paid to be in the study?

The study description does not mention any payment for participation.

Who will see my personal information?

The study collects information anonymously, meaning your name and personal details won't be linked to the data collected, to protect your privacy.