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Leg UlcerNCT03186560

Speckle Study: In Arterial, Mixed and Diabetic Foot Ulcers

A study testing gekoTM in people with Leg Ulcer, run by Firstkind Ltd at 3 sites in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a single centre open label study measuring microcirculatory flux using Speckle imaging Device. Microcirculation will be measured using laser speckle contrast imaging, at baseline and with the device active for 30 minutes in the wound, peri-wound and other point on the lower leg. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Leg Ulcer
What is being tested?
gekoTM
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
3 sitesUnited Kingdom
Study dates
12 Feb 2018to 26 Jan 2023
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

  • In order to be eligible to enter the study patients must meet the following criteria:
  • 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
Show all 12Show fewer
  • Specific inclusion criteria for the subgroups:
  • Group A: Arterial Leg Ulcer
  • Defined as healing/non-healing Group B: Mixed Leg Ulcer (only to be done once Arterial leg ulcers show change in flux)
  • ABPI of <0.8-0.6 Group C: Diabetic Foot Ulcer - neuropathic
  • On clinical inspection present as neuropathic Group D: Diabetic Foot Ulcer - neuroischemic
  • On clinical inspection present as neuroischemic

Who cannot join

  • Patients will not be admitted to the study if they meet any of the following exclusion criteria:
  • Significant (not colonialization) 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
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  • 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 that will prevent stimulation of the leg with geko (non-responders)
  • Size of leg incompatible with the geko™ device., i.e prevents device from stimulating the common peroneal nerve
  • obesity (BMI > 35)
  • Any medication deemed to be significant by the Investigator
  • Specific exclusion criteria for different subgroups:
  • Group A: Arterial Leg Ulcer - Mixed leg ulcer, diabetic foot ulcer or diabetic foot ulcer with neuroischaemic element.
  • Group B: Mixed Leg Ulcer
  • Arterial leg ulcer, diabetic foot ulcer or diabetic foot ulcer with neuroischaemic element.
  • Group C: Diabetic Foot Ulcer - Mixed leg ulcer, Arterial leg ulcer, or diabetic foot ulcer with neuroischaemic element.
  • Group D: Diabetic Foot Ulcer - neuroischemic
  • Mixed leg ulcer, Arterial leg ulcer or diabetic foot ulcer

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites
  • Glenfield Hospital

    Leicester, LE3 9QP

  • Aneurin Bevan Local Health Board

    Newport, NP18 3XG

  • Welsh wound Innovation Centre

    Wales, cf72 8ux

Other trials in United Kingdom

About this study

Official title: A Single Centre Open Label Study Measuring Microcirculatory Flux Using Speckle Imaging Device, in Patients With Arterial, Mixed and Diabetic Foot Ulcers Using gekoTM Neuromuscular Electrostimulation (NMES)

This is a single centre open label study measuring microcirculatory flux using Speckle imaging Device.

Microcirculation will be measured using laser speckle contrast imaging, at baseline and with the device active for 30 minutes in the wound, peri-wound and other point on the lower leg. The same procedure will be done on all the different patient groups.

Temperature variations can be assessed using Infrared Temperature Scanner (Exergen DermaTemp DT1001), a measurement will be taken at baseline, and then at 5 minutes interval during the 30 minutes activity of the device.

Read the detailed description

The most common underlying etiologic factors responsible for chronic delayed healing among lower extremity wounds encountered in the outpatient clinic are chronic venous insufficiency (CVI), diabetic neuropathy, and arterial insufficiency (AI). One or more of these factors can be identified in more than 90% of chronic lower extremity ulcers, and treatment protocols have been designed to manage wounds of each type to maximize healing potential. It is important to remember that multiple factors may coexist in any individual patient with a chronic wound, complicating management and hindering the healing process. Recently, it has been reported that the neuroischemic diabetic foot ulcer is now more common than nonischemic neuropathic diabetic foot ulcers, as arterial insufficiency promoted by poorly controlled diabetes complicates already impaired healing present in patients with diabetes.

Chronic leg ulcers are painful, debilitating wounds that place a significant burden on the patient, their family, and healthcare resources. Treating leg ulcers can present a significant challenge to clinicians, who currently have a limited range of treatments at their disposal. The mainstay of treatment is compression bandaging, ambulation and elevation at rest. In patients with mobility deficits, or in those who are unable to tolerate compression bandaging, ulcers may deteriorate and never heal. Accordingly, there is a need for novel, alternative devices or strategies that can be used to complement or replace compression therapy.

Numerous pathophysiological and metabolic factors can affect wound healing and result in a poor outcome. They include local causes such as oedema, ischemia, tissue hypoxia, infection, necrosis and growth factor imbalance, as well as systemic causes including metabolic disease, nutritional status general perfusion disturbances and pre-existing illness. These factors alter the wound repair environment, impede healing and increase the risk of chronic wound development. All healing processes including, inflammatory cell influx, fibroblast migration, and collagen and extracellular matrix deposition, are delayed in this situation, leading to prolonged wound healing.

Any wound management should assist the healing process and optimise the patient's blood flow to the wound area4. An acute wound in a stable patient with normal blood flow should heal successfully. Anything that compromises tissue oxygen delivery, such as poor vascularisation, will impede healing. There is a strong scientific basis for oxygen treatment as prophylaxis against infection; to facilitate wound closure and to prevent amputation in wounded patients. Oxygen delivery is a critical element for the healing of wounds. Hypoxemia, caused by disrupted vasculature, is a key limiting factor against wound healing.

The link between compromised circulation and ulceration is well established and well described. Chronic venous insufficiency is a direct cause of ulceration.

Diabetic foot ulcer is a major complication of diabetes mellitus, and probably the major component of the diabetic foot. Diabetes mellitus is one such metabolic disorder that impedes the normal steps of the wound healing process. Many studies show a prolonged inflammatory phase in diabetic wounds, which causes a delay in the formation of mature granulation tissue and a parallel reduction in wound tensile strength.

Treatment of diabetic foot ulcers should include: blood sugar control, removing dead tissue from the wound, dressings, and removing pressure from the wound through techniques such as total contact casting. Surgery in some cases may improve outcomes. Hyperbaric oxygen therapy may also help but is expensive. It occurs in 15% of people with diabetes and precedes 84% of all diabetes-related lower-leg amputations.

Conditions
Leg Ulcer
Being tested
gekoTM
Keywords
Leg ulcers and use of geko device
Medical subject headings
Leg Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gekoTMDevice

    The geko™ W devices are small disposable, internally powered, neuromuscular stimulators that are applied externally to the leg. The W device has a fixed 27mA current. The devices are self-adhesive and are applied to the outer/posterior aspect of the knee. This positioning enables integral electrodes to apply a stimulus to the lateral popliteal nerve (often additionally termed the common peroneal) which branches from the sciatic nerve. This nerve controls the contraction of several muscles in the lower leg.

Study groups in NCT03186560
Study groupRoleWhat they receive
Group A: Arterial Leg UlcerActive comparatorDefined as healing/non-healing Healing defined as reduction in wound area of greater than 20% over a 2-week period
Receives: Device: gekoTM
Group B: Mixed Leg UlcerActive comparatoronly to be done once Arterial leg ulcers show change in flux ABPI of <0.8-0.6
Receives: Device: gekoTM
Group C: Diabetic Foot Ulcer - neuropathicActive comparatorOn clinical inspection present as neuropathic
Receives: Device: gekoTM
Group D: Diabetic Foot Ulcer - neuroischemicActive comparatorOn clinical inspection present as neuroischemic
Receives: Device: gekoTM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Microcirculatory flux in the lower limb of the different subgroups with geko device on.

    Measurements of microcirculatory flux in the lower limb of the different subgroups with geko device on.

    Measured: 35 minutes

Secondary outcomes (2)
  1. Temperature variation

    measurements of Temperature over same time period as speckle device using the Exergen DermaTemp model DT1001.

    Measured: 35 minutes

  2. Adverse Events

    study rate of adverse events

    Measured: 35 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2017
  2. Study start12 Feb 2018
  3. Primary completion26 Jan 2023
  4. Study completion26 Jan 2023

Why it stopped: Difficulties with recruitment

Resources

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
Non-randomised
Intervention model
Crossover
Model description
Geko device will be provided
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03186560
Sponsor's protocol ID
FSK-Speckle-001
Status last verified
Aug 2023
First submitted
5 Jun 2017
Last updated
22 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bosanquet DC, Ivins N, Jones N, Harding KG. Microcirculatory Flux and Pulsatility in Arterial Leg Ulcers is Increased by Intermittent Neuromuscular Electrostimulation of the Common Peroneal Nerve. Ann Vasc Surg. 2021 Feb;71:308-314. doi: 10.1016/j.avsg.2020.07.030. Epub 2020 Aug 5.

    PubMed 32768540

Questions about this trial

What is this clinical trial studying?

A study testing gekoTM in people with Leg Ulcer, run by Firstkind Ltd at 3 sites 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 12 inclusion and 20 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: stopped early, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 was stopped early (reason given: Difficulties with recruitment). Results are not available in the source record.

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?

Microcirculatory flux in the lower limb of the different subgroups with geko device on. (time frame: 35 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03186560, which also lists 1 linked publication.

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 22 Aug 2023.

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