Efficacy Study for Geko Device in VLU Patients (Canada)

NCT ID: NCT05057793

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-22
• Study Completion Date: 2022-09-23

Brief Summary

The objective of this study is to compare the efficacy of a daily geko™ wound therapy (duration of 12 hours), in conjunction with standard of care (SC), to SC alone, in participants with venous leg ulcers.The participants will go through a four-week run-in phase, followed by a four-week treatment phase and a three-month long term follow-up.

Detailed Description

This study is designed to evaluate the efficacy of geko™ therapy for 12 hours daily in conjunction with Standard Care (SC), consisting of multilayer, multicomponent compression therapy intended for the treatment of VLUs, compared to SC alone in participants with VLUs.

The study will be a multicentre study with study centres in Ontario Canada.

The study will have three phases:

1. A four-week Run-In Phase (day 0-28)

2. A four-week Treatment Phase (day 28-56)

3. A long term Follow-Up Phase (day 84, 112 & 140 after EOT)

During the Run-In Phase all participants will receive SC only and will be evaluated on a weekly basis (day 0, 7, 14 & 21). On day 28, once the Investigator has confirmed the participant's continued eligibility, randomization and assignment to study treatment will take place. During the long term follow-up phase, participants continue with their assigned study treatment and will be seen and evaluated on day 84, 112 and 140

Conditions

Venous Leg Ulcer; Leg Ulcer; Venous Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard of care

Multilayer, multicomponent compression intended for the treatment of VLU

Group Type: NO_INTERVENTION

No interventions assigned to this group

Standard of care + geko 12h

Multilayer multicomponent compression intended for the treatment of VLU in conjuction with geko™ therapy 12 hours daily

Group Type: ACTIVE_COMPARATOR

geko

Intervention Type: DEVICE

The geko device will be self-administered and deliver 12 hours of therapy daily.

Interventions

geko

The geko device will be self-administered and deliver 12 hours of therapy daily.

Intervention Type: DEVICE

Other Intervention Names

NMES; geko device; geko 12h

Eligibility Criteria

Inclusion Criteria

1. Aged ≥ 18 years, able to provide written informed consent and comply with all study procedures and visit schedule

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

3. Have a (chronic) venous leg ulcer determined to be due to underlying venous disease following evaluation in a multi-professional setting or by a vascular surgeon, specialist physician or nurse wound specialist in accordance with Wounds Canada (2018), Health Quality Ontario Standards

4. A VLU of approximately ≥ 5cm2 and ≤ 40cm2 at study enrolment i.e. Run in Phase Visit 1. If more than one ulcer is present, the largest ulcer within the given size range will be designated the study ulcer and the only one included in the study. If other ulcerations are present on the same leg, they must be more than 2 cm apart if they are two separate wounds.

5. Study ulcer (current episode of ulceration in case of ulcer recurrence) has been present for at least 6 weeks but no more than 5 years prior to study entry.

6. Ankle-Brachial Pressure Index (ABPI) of 0.8 -1.2 ± 0.05 inclusive (or equivalent measure) measured at study entry or within 12 weeks of study entry.

7. No active local index wound infection for a minimum of 48 hours prior to study entry (RV1)

8. No systemic antimicrobial treatment for a minimum of seven days prior to study entry (RV1) prescribed for index wound infection

9. Must understand and is willing and able to participate in the study and to comply with all study procedures and study visit schedule

Exclusion Criteria

1. Known allergy or intolerance to any of the protocol-stipulated treatments

2. History of significant haematological disorders (e.g. Sickle Cell disease)

3. History of Deep Vein Thrombosis (DVT) within six months preceding study entry

4. History of Pyoderma Gangrenosum or other inflammatory ulceration

5. BMI ≥ 40

6. Pregnancy or risk of pregnancy

7. Use of investigational drug or device within four weeks prior to study entry that may interfere with the study

8. Use of any neuro-modulation device

9. Surgery during three months prior to study entry (such as abdominal, gynaecological, hip or knee replacement)

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

11. Implanted with a pacemaker or implantable cardioverter defibrillator (ICD).

12. Any medication deemed by the Investigator to potentially interfere with the study treatment (e.g. higher dose systemic steroids).

13. Participation in any other clinical study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Firstkind Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Garry Sibbald

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

The Mayer Institute

Hamilton, , Canada

Vascular Health Bronte

Oakville, , Canada

Care Partners (Waterloo)

Waterloo, , Canada

Countries

Canada

Related Links

https://www.gekodevices.com/

Device official website

Other Identifiers

FSK-VLU-006

Identifier Type: -

Identifier Source: org_study_id