← Back to Search

Standard of care + geko 12h for Venous Ulcers

N/A
Waitlist Available
Led By Garry Sibbald
Research Sponsored by Firstkind Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial will compare the effectiveness of a daily 12-hour geko™ therapy to standard care alone in treating venous leg ulcers. There will be a four-week run-in phase, followed by a four-week treatment phase, and a three-month long-term follow-up.

Eligible Conditions
  • Venous Ulcers
  • Leg Ulcer
  • Venous Leg Ulcer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in linear healing rate in the treatment phase compared to the run-in phase
Secondary outcome measures
Pain
Change in quality of life using the CWIS (Cardiff Wound Impact Schedule)
Change in quality of life using the EQ-5D-5L (health-related quality of life measure) questionnaire
+1 more

Trial Design

2Treatment groups
Active Control
Group I: Standard of careActive Control1 Intervention
Multilayer, multicomponent compression intended for the treatment of VLU
Group II: Standard of care + geko 12hActive Control1 Intervention
Multilayer multicomponent compression intended for the treatment of VLU in conjuction with geko™ therapy 12 hours daily

Find a Location

Who is running the clinical trial?

Firstkind LtdLead Sponsor
24 Previous Clinical Trials
6,582 Total Patients Enrolled
Garry SibbaldPrincipal InvestigatorUniversity of Toronto

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have enrolled in this research endeavor?

"Affirmative. Clinicaltrials.gov confirms that recruitment is still active for this medical experiment, initially published on September 1st 2022 and modified as recently as August 4th of the same year. 80 subjects need to be enrolled across 3 sites in total."

Answered by AI

Are there any openings for volunteers in this research endeavor?

"This clinical investigation is currently attempting to enroll participants, which was first made available on September 1st 2022 and recently modified on August 4th."

Answered by AI
~1 spots leftby Mar 2025