Speckle Study: In Arterial, Mixed and Diabetic Foot Ulcers

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.

Study Overview

• Status: Terminated
• Conditions: Leg Ulcer
• Intervention / Treatment: Device: gekoTM

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kieron Day, PhD; Phone Number: 01494572042; Email: Kieron.Day@firstkindmedical.com

Study Locations

• United Kingdom
  • Leicester, United Kingdom, LE3 9QP
    • Glenfield Hospital
  • Newport, United Kingdom, NP18 3XG
    • Aneurin Bevan Local Health Board
  • Wales, United Kingdom, CF72 8UX
    • Welsh wound Innovation Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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
• 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

Exclusion Criteria:

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A: Arterial Leg Ulcer; Defined as healing/non-healing Healing defined as reduction in wound area of greater than 20% over a 2-week period	Device: gekoTM; 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.
Active Comparator: Group B: Mixed Leg Ulcer; only to be done once Arterial leg ulcers show change in flux ABPI of <0.8-0.6	Device: gekoTM; 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.
Active Comparator: Group C: Diabetic Foot Ulcer - neuropathic; On clinical inspection present as neuropathic	Device: gekoTM; 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.
Active Comparator: Group D: Diabetic Foot Ulcer - neuroischemic; On clinical inspection present as neuroischemic	Device: gekoTM; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	35 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature variation	measurements of Temperature over same time period as speckle device using the Exergen DermaTemp model DT1001.	35 minutes
Adverse Events	study rate of adverse events	35 minutes

Collaborators and Investigators

• Sponsor: Firstkind Ltd
• Investigators: Principal Investigator: David Bosanquet, Aneurin Bevan University Health Board

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2018
• Primary Completion (Actual): January 26, 2023
• Study Completion (Actual): January 26, 2023

Study Registration Dates

• First Submitted: June 5, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Leg ulcers and use of geko device
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Leg Ulcer
• Other Study ID Numbers: FSK-Speckle-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No