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Efficacy Study for Geko Device in VLU Patients

NCT03396731 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2023-09-21

No results posted yet for this study

Summary

Eight weeks, comprised of four weeks Run-in Phase of Standard Care (SC) treatment followed by four weeks of treatment allocated by randomisation (Treatment Phase).

To compare two daily geko™ device treatment durations, six hours and 12 hours, in conjunction with SC, with each other and to SC alone, in patients with venous leg ulcers

Conditions

  • Venous Leg Ulcer
  • Leg Ulcers Venous
  • Leg Ulcer
  • Wound Leg
  • Wound

Interventions

DEVICE

geko™ medical device

The geko™ device, manufactured by Firstkind Ltd (High Wycombe, United Kingdom), is a small disposable, battery powered CE marked medical device.

Sponsors & Collaborators

  • Firstkind Ltd

    lead INDUSTRY

Principal Investigators

  • Keith Harding, FRCGP FRCP FRCS · Welsh Wound Innovation Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-24
Primary Completion
2022-05-17
Completion
2022-08-09

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03396731 on ClinicalTrials.gov