Venous Leg UlcerNCT02884323
A Study in Patients With Venous Leg Ulcers and Measuring the Effects of Using Geko™ Device
A study testing geko™ device in people with Venous Leg Ulcer, run by Firstkind Ltd at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- geko™ device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2016to 2 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The University of Manchester Academic Surgery Unit 2nd Floor, ERC University Hospital of South Manchester M23 9LT
Manchester, M23 9LT
About this study
Official title: A Single Centre Open Label Pilot Study Measuring Lower Limb Physiology in Patients With Venous Leg Ulcers Using the Geko™ T-2 or gekoTM Plus [R-2] Neuromuscular Electro Stimulation Device
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
- Being tested
- geko™ device
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
geko™ deviceDevice
The geko™ (T-2 and R-2) devices are small disposable, internally powered, neuromuscular stimulators that are applied externally to the leg.
| Study group | Role | What they receive |
|---|---|---|
| geko device arm | Experimental | Not described Receives: Device: geko™ device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Secondary outcomes (4)
The acute effect of the geko™ device on lower leg venous transit times
Using an ultrasound contrast agent to detect venous flow using Ultrasound imaging. Ultrasound images will be produced and a comparison of results between baseline and using geko™ device will be assessed.
Measured: 2 hours
The acute effect of the geko™ device on wound tissue oxygen levels
The patient will have multipsectral images taken of the ulcer using a fixed camera. The outcome measures (proportions of deoxy- and oxyhaemoglobin) will be displayed on an attached PC.
Measured: 2 hours
The effect of the geko™ device on lower leg microcirculation
Laser Speckle contrast imaging will be applied to record images at baseline and with geko™ device
Measured: 2 hours
Adverse events assessments
Patients will be monitored for adverse events throughout the duration of the study. Adverse events may be spontaneously reported by the subject, observed by the study personnel.
Serious Adverse Events will be reported to the Sponsor, the National Research Ethics Service (NRES) recognised Research Ethics Committee.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion2 Jul 2018
- Study completion2 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firstkind Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles McCollum, Principal investigator, UHSM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884323
- Sponsor's protocol ID
- FSK-VLU-002
- Status last verified
- May 2022
- First submitted
- 17 Aug 2016
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre Open Label Pilot Study Measuring Lower Limb Physiology in Patients With Venous Leg Ulcers Using the Geko™ T-2 or gekoTM Plus [R-2] Neuromuscular Electro Stimulation Device
- ClinicalTrials.gov ID
- NCT02884323
- Acronym / sponsor ID
- FSK-VLU-002
- Conditions
- Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Firstkind LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 2 Jul 2018 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| geko device arm | Experimental | Device: geko™ device |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| geko™ deviceThe geko™ (T-2 and R-2) devices are small disposable, internally powered, neuromuscular stimulators that are applied externally to the leg. | Device | geko device arm |
Primary outcome
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
Time frame: 2 hours
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.
4 secondary outcomes
The acute effect of the geko™ device on lower leg venous transit times
Time frame: 2 hours
The acute effect of the geko™ device on wound tissue oxygen levels
Time frame: 2 hours
The effect of the geko™ device on lower leg microcirculation
Time frame: 2 hours
Adverse events assessments
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles McCollum principal investigator
UHSM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing geko™ device in people with Venous Leg Ulcer, run by Firstkind Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.