A Study in Patients With Venous Leg Ulcers and Measuring the Effects of Using Geko™ Device

NCT02884323 | Completed

• 1 other identifier: FSK-VLU-002
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single centre open label study measuring lower limb physiology in patients with venous leg ulcers at the University Hospital of South Manchester. Ambulatory venous pressure, venous transit times, wound bed tissue oxygenation and changes in microcirculation will be measured at baseline after the gekoTM device is activated. Ambulatory venous pressure and venous transit times will be performed whilst the participant is standing, sitting and supine

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• The acute effect of the geko™ device on ambulatory venous pressure in patients with venous leg ulcers will be evaluated when sitting, standing or supine

  using Lectromed Multitrace II venous pressure recording system, this will measure Ambulatory venous pressure which will show any influence, if any, gekoTM has on AVP.

  2 hours

Secondary Outcomes (4)

• The acute effect of the geko™ device on lower leg venous transit times

  2 hours

• The acute effect of the geko™ device on wound tissue oxygen levels

  2 hours

• The effect of the geko™ device on lower leg microcirculation

  2 hours

• Adverse events assessments

  2 hours

Study Arms (1)

geko device arm

EXPERIMENTAL

Device: geko™ device

Interventions

geko™ device DEVICE

The geko™ (T-2 and R-2) devices are small disposable, internally powered, neuromuscular stimulators that are applied externally to the leg.

geko device arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Intact healthy skin at the site of device application
• Able to understand the Patient Information Sheet
• Willing and able to give informed consent
• Willing and able to follow the requirements of the protocol
• Subjects who had a chronic venous leg ulcer (i.e. CEAP classification of C6 1) greater than 1 cm2 and less than 10 cm in maximum diameter,
• ABPI of ≥0.8
• Patient treated with 4 layer compression bandaging

You may not qualify if:

• Wound infection either acute or chronic
• History of significant haematological disorders or DVT with the preceding six months
• Pregnant
• Pacemakers or implantable defibrillators
• Use of any other neuro-modulation device
• Current use of TENS in pelvic region, back or legs
• Use of investigational drug or device within the past 4 weeks that may interfere with this study
• Recent surgery that may affect the study (such as abdominopelvic, or lower limb) in the opinion of the investigator.
• Recent trauma to the lower limbs
• Size of leg incompatible with the geko™ device.
• Obesity (BMI \> 34)
• Any medication deemed to be significant by the Investigator
• Subjects who had an index venous leg ulcer greater in maximum diameter than 10cm in any one dimension, or less than 2cm.
• Diabetes
• Clinical evidence of peripheral arterial disease (i.e signs or symptoms, in the opinion of the researcher)

Sponsors & Collaborators

• Firstkind Ltd: lead

Study Sites (1)

The University of Manchester Academic Surgery Unit 2nd Floor, ERC University Hospital of South Manchester M23 9LT

Manchester, M23 9LT, United Kingdom

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Charles McCollum

  UHSM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 31, 2016
• Study Start: August 1, 2016
• Primary Completion: July 2, 2018
• Study Completion: July 2, 2018
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)