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Speckle Study: In Arterial, Mixed and Diabetic Foot Ulcers

NCT03186560 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-08-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Firstkind Ltd

    lead INDUSTRY

Principal Investigators

  • David Bosanquet · Aneurin Bevan University Health Board

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-12
Primary Completion
2023-01-26
Completion
2023-01-26

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03186560 on ClinicalTrials.gov