Speckle Study: In Arterial, Mixed and Diabetic Foot Ulcers

NCT03186560 | Terminated

• 1 other identifier: FSK-Speckle-001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Leg Ulcer

Keywords

Leg ulcers and use of geko device

Outcome Measures

Primary Outcomes (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.

  35 minutes

Secondary Outcomes (2)

• Temperature variation

  35 minutes

• Adverse Events

  35 minutes

Study Arms (4)

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

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

Device: gekoTM

Group C: Diabetic Foot Ulcer - neuropathic

ACTIVE COMPARATOR

On clinical inspection present as neuropathic

Device: gekoTM

Group D: Diabetic Foot Ulcer - neuroischemic

ACTIVE COMPARATOR

On clinical inspection present as neuroischemic

Device: gekoTM

Interventions

gekoTM DEVICE

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.

Group A: Arterial Leg Ulcer; Group B: Mixed Leg Ulcer; Group C: Diabetic Foot Ulcer - neuropathic; Group D: Diabetic Foot Ulcer - neuroischemic

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Firstkind Ltd: lead

Study Sites (3)

Glenfield Hospital

Leicester, LE3 9QP, United Kingdom

Location

Aneurin Bevan Local Health Board

Newport, NP18 3XG, United Kingdom

Location

Welsh wound Innovation Centre

Wales, cf72 8ux, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32768540 DERIVED

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David Bosanquet

  Aneurin Bevan University Health Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Geko device will be provided

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 14, 2017
• Study Start: February 12, 2018
• Primary Completion: January 26, 2023
• Study Completion: January 26, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)