Efficacy Study for Geko Device in VLU Patients (Canada)

NCT05057793 | Terminated

• 1 other identifier: FSK-VLU-006
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 3

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.

Conditions

Venous Leg Ulcer; Leg Ulcer; Venous Ulcer

Keywords

geko; compression bandaging; wound; ulcer

Outcome Measures

Primary Outcomes (1)

• 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).

  8 weeks

Secondary Outcomes (4)

• Weekly change in linear healing rate

  8 weeks

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

  8 weeks

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

  8 weeks

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

  8 weeks

Study Arms (2)

Standard of care

NO INTERVENTION

Multilayer, multicomponent compression intended for the treatment of VLU

Standard of care + geko 12h

ACTIVE COMPARATOR

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

Device: geko

Interventions

geko DEVICE

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

Also known as: NMES, geko device, geko 12h

Standard of care + geko 12h

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Firstkind Ltd: lead

Study Sites (3)

The Mayer Institute

Hamilton, ONL8R2R3, Canada

Location

Vascular Health Bronte

Oakville, ONL6M4J2, Canada

Location

Care Partners (Waterloo)

Waterloo, ONN2L6H7, Canada

Location

Related Links

• Device official website

MeSH Terms

Conditions

Varicose Ulcer; Leg Ulcer; Wounds and Injuries; Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Garry Sibbald

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 27, 2021
• Study Start: August 22, 2022
• Primary Completion: September 23, 2022
• Study Completion: September 23, 2022
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)