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Efficacy Study for Geko Device in VLU Patients (Canada)

Primary Purpose

Venous Leg Ulcer, Leg Ulcer, Venous Ulcer

Status

Suspended

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

geko

About this trial

This is an interventional treatment trial for Venous Leg Ulcer focused on measuring geko, compression bandaging, wound, ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Aged ≥ 18 years, able to provide written informed consent and comply with all study procedures and visit schedule
Intact healthy skin at the site of geko™ device application.
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
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.
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.
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.
No active local index wound infection for a minimum of 48 hours prior to study entry (RV1)
No systemic antimicrobial treatment for a minimum of seven days prior to study entry (RV1) prescribed for index wound infection
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:

Known allergy or intolerance to any of the protocol-stipulated treatments
History of significant haematological disorders (e.g. Sickle Cell disease)
History of Deep Vein Thrombosis (DVT) within six months preceding study entry
History of Pyoderma Gangrenosum or other inflammatory ulceration
BMI ≥ 40
Pregnancy or risk of pregnancy
Use of investigational drug or device within four weeks prior to study entry that may interfere with the study
Use of any neuro-modulation device
Surgery during three months prior to study entry (such as abdominal, gynaecological, hip or knee replacement)
Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
Implanted with a pacemaker or implantable cardioverter defibrillator (ICD).
Any medication deemed by the Investigator to potentially interfere with the study treatment (e.g. higher dose systemic steroids).
Participation in any other clinical study

Sites / Locations

The Mayer Institute
Vascular Health Bronte
Care Partners (Waterloo)

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard of care

Standard of care + geko 12h

Arm Description

Multilayer, multicomponent compression intended for the treatment of VLU

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

Outcomes

Primary Outcome Measures

Change in linear healing rate in the treatment phase compared to the run-in phase

The pair-wise comparison of linear healing rate (wound margin advance, WMA) during Treatment Phase compared with WMA from the Run-in Phase both the treatment arm (SC plus 12 hours daily treatment with the geko™ W device or variant) and control arm (SC only).

Secondary Outcome Measures

Weekly change in linear healing rate

Weekly wound margin advance of the study ulcer measured by an independent blinded wound expert using digital images taken at each weekly visit until end of treatment.

Change in pain score using the VAS (Visual Analogue Scale)

Patient will indicate their pain score at each weekly visit using a visual analogue scale (VAS), with 0 being no pain at all and 100 being worst pain imaginable (measured in mm)

Change in quality of life using the EQ-5D-5L (health-related quality of life measure) questionnaire

EQ-5D-5L a descriptive system for health-related quality of life (HRQoL) states in adults, consisting of five dimensions (mobility, self-care, usual activities, pain & discomfort, anxiety & depression). Participant will complete questionnaire at the beginning of the run in phase, at randomization and at the end of treatment. Each level is scored ona 5 level severity ranking, with 1 being no problems, to 5 being extreme problems.

Change in quality of life using the CWIS (Cardiff Wound Impact Schedule)

Cardiff Wound Impact Schedule (CWIS) is used to measure the impact of chronic wounds (leg ulcers and diabetic foot ulcers) on HRQoL and identify areas of participant concern. The questionnaire will be completed by the participant at the beginning of the run in phase, at randomization and at the end of treatment. The overall score will be between 0 and 100, with a higher score indicating a better quality of life.

Full Information

NCT ID

NCT05057793

First Posted

September 16, 2021

Last Updated

August 18, 2023

Sponsor

Firstkind Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05057793

Brief Title

Efficacy Study for Geko Device in VLU Patients (Canada)

Official Title

A Prospective, Multicentre, Randomised, Assessor Blinded Study Comparing the Efficacy, Including Participant Reported Outcomes, of Daily Geko™ Therapy in Conjunction With Standard Care to Standard Care Alone, in Patients With Venous Leg Ulcers

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Suspended

Why Stopped

Difficulties with recruitment

Study Start Date

August 22, 2022 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Firstkind Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: A four-week Run-In Phase (day 0-28) A four-week Treatment Phase (day 28-56) 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Leg Ulcer, Leg Ulcer, Venous Ulcer

Keywords

geko, compression bandaging, wound, ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard of care

Arm Type

No Intervention

Arm Description

Multilayer, multicomponent compression intended for the treatment of VLU

Arm Title

Standard of care + geko 12h

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

geko

Other Intervention Name(s)

NMES, geko device, geko 12h

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in linear healing rate in the treatment phase compared to the run-in phase

Description

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Weekly change in linear healing rate

Description

Weekly wound margin advance of the study ulcer measured by an independent blinded wound expert using digital images taken at each weekly visit until end of treatment.

Time Frame

8 weeks

Title

Change in pain score using the VAS (Visual Analogue Scale)

Description

Patient will indicate their pain score at each weekly visit using a visual analogue scale (VAS), with 0 being no pain at all and 100 being worst pain imaginable (measured in mm)

Time Frame

8 weeks

Title

Change in quality of life using the EQ-5D-5L (health-related quality of life measure) questionnaire

Description

Time Frame

8 weeks

Title

Change in quality of life using the CWIS (Cardiff Wound Impact Schedule)

Description

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged ≥ 18 years, able to provide written informed consent and comply with all study procedures and visit schedule Intact healthy skin at the site of geko™ device application. 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 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. 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. 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. No active local index wound infection for a minimum of 48 hours prior to study entry (RV1) No systemic antimicrobial treatment for a minimum of seven days prior to study entry (RV1) prescribed for index wound infection 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: Known allergy or intolerance to any of the protocol-stipulated treatments History of significant haematological disorders (e.g. Sickle Cell disease) History of Deep Vein Thrombosis (DVT) within six months preceding study entry History of Pyoderma Gangrenosum or other inflammatory ulceration BMI ≥ 40 Pregnancy or risk of pregnancy Use of investigational drug or device within four weeks prior to study entry that may interfere with the study Use of any neuro-modulation device Surgery during three months prior to study entry (such as abdominal, gynaecological, hip or knee replacement) Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve. Implanted with a pacemaker or implantable cardioverter defibrillator (ICD). Any medication deemed by the Investigator to potentially interfere with the study treatment (e.g. higher dose systemic steroids). Participation in any other clinical study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Garry Sibbald

Organizational Affiliation

University of Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Mayer Institute

City

Hamilton

ZIP/Postal Code

ONL8R2R3

Country

Canada

Facility Name

Vascular Health Bronte

City

Oakville

ZIP/Postal Code

ONL6M4J2

Country

Canada

Facility Name

Care Partners (Waterloo)

City

Waterloo

ZIP/Postal Code

ONN2L6H7

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.gekodevices.com/

Description

Device official website

Learn more about this trial

Efficacy Study for Geko Device in VLU Patients (Canada)

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