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.
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
Show all 20Show fewer
- 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
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 group | Role | What they receive |
|---|---|---|
| Group A: Arterial Leg Ulcer | Active comparator | Defined 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 Ulcer | Active comparator | only 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 - neuropathic | Active comparator | On clinical inspection present as neuropathic Receives: Device: gekoTM |
| Group D: Diabetic Foot Ulcer - neuroischemic | Active comparator | On 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.
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)
Temperature variation
measurements of Temperature over same time period as speckle device using the Exergen DermaTemp model DT1001.
Measured: 35 minutes
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.
- First posted14 Jun 2017
- Study start12 Feb 2018
- Primary completion26 Jan 2023
- Study completion26 Jan 2023
Why it stopped: Difficulties with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Geko device will be provided
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firstkind Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Bosanquet, Principal investigator, Aneurin Bevan University Health Board
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03186560
- Acronym / sponsor ID
- FSK-Speckle-001
- Conditions
- Leg Ulcer
- Keywords
- Leg ulcers and use of geko device
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties with recruitment
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Firstkind LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 26 Jan 2023 (actual)
- Study completion
- 26 Jan 2023 (actual)
- First posted
- 14 Jun 2017 (actual)
- 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 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Geko device will be provided
| Arm | Type | Receives |
|---|---|---|
| Group A: Arterial Leg Ulcer | Active comparator | Device: gekoTMDefined as healing/non-healing Healing defined as reduction in wound area of greater than 20% over a 2-week period |
| Group B: Mixed Leg Ulcer | Active comparator | Device: gekoTMonly to be done once Arterial leg ulcers show change in flux ABPI of <0.8-0.6 |
| Group C: Diabetic Foot Ulcer - neuropathic | Active comparator | Device: gekoTMOn clinical inspection present as neuropathic |
| Group D: Diabetic Foot Ulcer - neuroischemic | Active comparator | Device: gekoTMOn clinical inspection present as neuroischemic |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 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 (20 listed)
- 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
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 |
|---|---|---|
| gekoTMThe 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. | Device | Group A: Arterial Leg Ulcer, Group B: Mixed Leg Ulcer, Group C: Diabetic Foot Ulcer - neuropathic, Group D: Diabetic Foot Ulcer - neuroischemic |
Primary outcome
Microcirculatory flux in the lower limb of the different subgroups with geko device on.
Time frame: 35 minutes
Measurements of microcirculatory flux in the lower limb of the different subgroups with geko device on.
2 secondary outcomes
Temperature variation
Time frame: 35 minutes
Adverse Events
Time frame: 35 minutes
Results and safety
The study was stopped early (reason given: Difficulties with recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Derived from this study: PubMed 32768540Bosanquet 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.
- Individual participant dataSharing planned: No
Related trials for Leg Ulcer
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Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
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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.
David Bosanquet principal investigator
Aneurin Bevan University Health Board
3 sites in 1 country: see every site and its status.
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.