WO2013144641A1 - Procédé et appareil destinés à tester des traitements d'une inflammation cutanée chronique et aiguë - Google Patents

Procédé et appareil destinés à tester des traitements d'une inflammation cutanée chronique et aiguë Download PDF

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Publication number
WO2013144641A1
WO2013144641A1 PCT/GB2013/050830 GB2013050830W WO2013144641A1 WO 2013144641 A1 WO2013144641 A1 WO 2013144641A1 GB 2013050830 W GB2013050830 W GB 2013050830W WO 2013144641 A1 WO2013144641 A1 WO 2013144641A1
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WO
WIPO (PCT)
Prior art keywords
load application
application mechanism
skin
trauma
blister
Prior art date
Application number
PCT/GB2013/050830
Other languages
English (en)
Inventor
Paul Busby
Saeed FORGHANY
Farina HASHMI
Suzanne KIRKHAM
Christopher J NESTER
Barry S RICHARDS
Ciaran WRIGHT
Original Assignee
Lrc Products Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lrc Products Limited filed Critical Lrc Products Limited
Priority to AU2013239470A priority Critical patent/AU2013239470B2/en
Priority to EP13717819.0A priority patent/EP2836108A1/fr
Publication of WO2013144641A1 publication Critical patent/WO2013144641A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0048—Detecting, measuring or recording by applying mechanical forces or stimuli
    • A61B5/0057—Detecting, measuring or recording by applying mechanical forces or stimuli by applying motion other than vibrations, e.g. rolling, rubbing, applying a torque, tribometry
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • A61B5/015—By temperature mapping of body part
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/44—Detecting, measuring or recording for evaluating the integumentary system, e.g. skin, hair or nails
    • A61B5/441—Skin evaluation, e.g. for skin disorder diagnosis
    • A61B5/445—Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4848—Monitoring or testing the effects of treatment, e.g. of medication
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6829—Foot or ankle

Definitions

  • the present invention is directed to a method for determining the efficiency of prevention, protection or therapeutic treatments of skin inflammation resulting from an excess or chronic load or pressure and apparatus for use in such a method.
  • Friction blisters, calluses and corns present in people of all ages and occur during either high levels of activity and/ or use of ill-fitting footwear and hosiery. Friction blisters (most commonly occurring on the heel), and calluses and corns (most commonly occurring on the forefoot and toes) are not trivial injuries, they can be painful, restrict normal foot function and place the lower limb at increased risk of infection. Altered gait is a common strategy adopted to reduce pressure (and pain) in the area of the FCC. This results in altered lower limb biomechanics and may increase risk of secondary injuries during periods of extended or intensive exercise.
  • the primary physical response of the skin to acute friction is the separation of intra- epidermal layers, at the level of the S. Spinosum, followed by a physiological response of acute inflammation, and with time this area is infiltrated with fluid thus forming a blister.
  • the clinical signs of acute inflammation are: redness, swelling, pain, heat, and disturbed function, which are all closely related to an increase in perfusion to the area.
  • This increased blood flow leads to an increase in temperature of the affected area.
  • Increased temperature is a cardinal sign of foot blisters due to the localized response to mechanical stress and damage to the epidermis.
  • Changes in skin temperature can therefore be used as an indicator of the early stages of FCC formation, and hence be used in assessing the efficacy of prevention, protection and therapeutic treatments.
  • the aim of this invention is to provide a mechanism to generate the correct level of trauma leading to skin inflammation in a controlled manner, and provide a means to test the efficacy of various interventions for treatment, prevention, or protection - for example, using skin temperature changes as an indicator of inflammation and the onset of FCC formation.
  • a Load Application Mechanism for use in a method for testing the efficacy of a preparation or dressing or other suitable product for the prevention of skin inflammation
  • the mechanism is used to generate a force or pressure, in combination with friction and shear, which leads to skin inflammation and comprises a contact means for rubbing against the skin of a participant and a means for controlling the rate at which the contact means contacts a participant's skin.
  • the contact means can be made of any material that is capable of increasing friction and compression causing mild or superficial trauma on the surface of the skin.
  • the material is selected from any material that is used to form the upper portion of a shoe, such as rubber, leather, synthetic textiles, or any material that is used to form a sock or hosiery textile such as cotton, wool, nylon or polyester.
  • a preferred material is rubber, which has a relatively high coefficient of friction when in contact with the skin.
  • the contact means is provided with a convex shape in such a way that the angle of contact between the surface of the contact means and the skin of a participant is less than 90 degrees. Typically the angle is between 30 and 60 degrees.
  • the contact means also has provision for applying compression combined with shear to the skin.
  • the vertical displacement of the contact means ranges from 10mm to 30mm, and is typically 15mm.
  • the contact means will typically exert a pressure on the skin of a user of up to 490kPa.
  • a typical pressure range is between 50 and 90 kPa for friction blister creation and 320 and 490 kPa for corn and callus formation.
  • Incorporated within the contact means are 3 dimensional load sensors cells which are able to quantify load application values to the skin. These loads represent those experienced during walking and running.
  • the contact means is secured to an adjacent housing which includes the means for controlling the rate at which the contact means makes contact with the skin of a participant.
  • This housing can either be manually controlled or could enable programmed automated movement of the contact means.
  • the LAM operates at speeds ranging between 30 and 240 passes/minute. Typically the speed for blister creation ranges from 30 to 120 passes/min and for corn and callus creation the range is 60 to 240 passes per minute. Each pass represents the contact means passing in one direction against the skin of a participant.
  • the LAM is able to operate under various rubbing profiles: principally a two- directional linear or curved (e.g. up-and-down) rubbing motion, as well as a uni- directional linear rubbing (e.g. an upwards-only, or downwards-only contact passes) option, generally in a circular or elliptical motion.
  • a two- directional linear or curved (e.g. up-and-down) rubbing motion as well as a uni- directional linear rubbing (e.g. an upwards-only, or downwards-only contact passes) option, generally in a circular or elliptical motion.
  • the LAM is used in different time cycles in order to create the desired trauma.
  • blister creation which is an acute trauma
  • the load application is semi-continuous until the end point is reached, whereby the end point could be a specific temperature increase, change in skin colour, early signs of damage, signs of blister, and so on. Typically, this occurs within minutes for the average foot.
  • corn and callus formation which are longer-term trauma exposure, the load application is intermittent over a longer period of time in controlled cycles. Thus corns and calluses are formed over days of lower-level loading rather than minutes.
  • the load applicator can be used to test the efficacy of prevention treatments on any suitable part of the body.
  • Preferred parts are the heel and the plantar surface of the foot.
  • a method of testing the efficiency of trauma protection and/ or prevention treatments comprising causing partial or full trauma and an increase in skin temperature using the load application mechanism described in the first aspect, applying a protection or further preventative treatment thereto and continuing with the load application to measure the effect of the protection or prevention treatment on rate of increase in skin temperature or trauma.
  • changes in the biophysical properties of the skin with time can be measured using skin hydration meters, elastometry and surface texture imaging of the skin under magnification. Differences in the nature of the skin in response to trauma can be identified.
  • the skin temperature is measured using Infrared thermography, which is widely used to monitor thermal changes in skin pathologies, such as: malignancies, inflammation, infection, vascular defects, dermatological, and rheumatic disorders.
  • plantar temperature has been used as a marker for inflammation in diabetes.
  • the advantages of thermal imaging methods are that they are noninvasive, non-contact and do not restrict data collection to one site because data can be captured across a wide surface area synchronously. It thus offers excellent opportunity to observe thermal changes due to friction, compression and shear at sites on the foot and monitor changes in foot inflammation status over time.
  • thermography method measures a change in temperature over time. In the case of acute trauma (or blister formation), this is typically of up to 5.0 ⁇ 2.5 °C at point of blister creation.
  • the measures of significant changes in hydration, elasticity and surface texture are typically: 6 AU, 0.4mm (displacement) and 3 AU respectively, when measured with a Corneometer ® Curometer ® and Viscioscan ® (Courage and Khazaka, Germany).
  • a method of determining the efficiency of treatments for healing or reducing mild or superficial skin trauma comprising causing trauma and an increase in skin temperature using the load application mechanism described in the first aspect, applying a healing treatment thereto and measuring the effect of the treatment of a participant's skin post-trauma.
  • Figures 1 (a) - (c) illustrate embodiments of the device of the first aspect of the present invention and how they can be used;
  • Figure 2 illustrates the mean temperature change ( ⁇ standard deviation, SD) from baseline at test and control sites at point of trauma formation, 0.5, 1 .5 and 5.5 hours post-trauma formation;
  • Figure 3 illustrates the relationship between temperature readings taken from a thermal imaging camera and a contact thermometer at test and control sites
  • Figure 4 illustrates the effect of pre-hydration of the foot on the rate of change of temperature from baseline by comparing the hydrated foot and the non hydrated foot;
  • Figure 5 illustrates the average change in temperature from baseline in response to load application over time for the test and control site hydrated and non-hydrated groups
  • Figure 6 shows the duration (in minutes) taken to get to an end-point for both the hydrated group and non-hydrated group
  • Figure 7 shows the relationship between rate of change in temperature from baseline and skin surface hydration
  • Figure 8 shows the relationship between rate of change in temperature from baseline and skin elasticity
  • Figure 9 shows the difference between the product and non-product foot within the same intervention group where a) represents the powder group, b) represents the film former group and c) represents the antiperspirant group.
  • the 'product foot' is described as the foot onto which the product was used, and the 'non-product foot' is described as the foot onto which no product was used.
  • Figure 10 illustrates the emerging trends in the effect of the three preventative products on the rate of change in temperature for both the product and non-product foot (rate of change in temperature is taken as a surrogate for rate of inflammation)
  • Figure 1 1 illustrates the difference between the rate of change of temperature from baseline between the three intervention groups.
  • Example 1 A combined friction and compression load was applied to the posterior heel of 30 volunteers.
  • the test in Example 1 was conducted in the context of generating blisters, and not corns and callus. Temperatures at the test (friction) and a control sites were recorded using a contact thermometer and an infrared thermal imaging camera. Temperature readings were taken during and 5.5 hours post-blister formation.
  • the product could be applied onto the skin prior to loading or after loading as per the first and third aspect, but in this particular case no product was used.
  • Thermal imaging camera FLIRTM SC620 Thermal Camera (FLIR Systems Inc., West Mailing, UK): pixel resolution 80 x 80, temperature range 0°C to +250°C, accuracy ⁇ 0.2°C.
  • Supporting software Therm CAMTM Quick Report Version 1 .1 .
  • Infrared contact thermometer (Brannan Thermometers, Cumbria, UK): Temperature range: -22 - 80°C, accuracy ⁇ 0.2°C.
  • the LAM comprised a spring operated rotating load applicator with a curved anterior surface ( Figure 1 ) and a strip (60 mm x 30 mm x 0.9 mm) of textured rubber material (Ironman Rubber Covering, Black, OB2090, Algeos UK Ltd., Liverpool, UK) providing an interface with the skin. This covering had a rough upper surface, creating friction between the device and skin.
  • the rubber strip was cleaned with hard surface alcohol disinfectant prior to use and a new piece of material was used for each participant.
  • the device was secured to a platform adjacent to the participant's feet and positioned such that the load applicator aligned with the back of the heel (Figure. 1 a). Two shoe inserts were used to standardise foot position.
  • the vertical displacement of the LAM was mechanically limited to 15 mm. This range was determined from a pilot study using slow motion high speed video analysis to determine the displacement of the heel relative to the back of a shoe at heel strike. The downward and upward displacement of the LAM was operated manually.
  • inventions shown in Figures 1 (b) and 1 (c) operate in an elliptical manner contacting the skin in one direction (either up or down).
  • the load applicator was positioned such that when in maximum contact with the heel the pressure was 70kPa (7N/ cm 2 ), measured using a pressure switch. Pilot work conducted during the design of the LAM identified this as an appropriate level of pressure to encourage blister creation without abrading skin or de-roofing the blister.
  • the thermal imaging camera was then positioned 0.5 m from the back of the heel and at an angle of 45° to the long axis of the foot (heel to second toe axis). Baseline temperatures and skin surface hydration were recorded at test and control skin sites.
  • the load applicator was operated manually at a rate of 120 passes/ min (60 upwards and 60 downwards rubbing contact passes), where one pass represents the LAM passing against the skin once This rate was set to replicate fast walking (approximately 120 steps per minute).
  • the load was applied in this manner continuously for 2 minutes, followed by a 1 minute period during which the investigator recorded thermal image and contact thermometer temperatures.
  • the skin was also visually inspected for any signs of tissue damage. For the purpose of recording the data, the 2 + 1 minutes was called one "load-rest cycle".
  • Load-rest cycles were repeated until the early signs of blister formation were observed, which were the appearance of: 1 ) a blanched area of skin within the erythematous, affected area of skin; and 2) a visible pleat of epidermis lifted from the underlying dermis.
  • the load application was terminated on the initial appearance of the blister.
  • the temperature readings were then recorded every 3 minutes for 30 minutes whilst the participant remained standing. Thereafter, data was collected every hour for 5 hours. After the initial 30 minutes post blister participants were allowed to leave the test room but asked to wear footwear that placed no pressure on the area of the blister (e.g. open back sandals).
  • Stage 1 onset of external load application to the time of the initial appearance of a blister (the number of temperature readings recorded depended on the number of load-rest cycles needed to initiate a blister);
  • Stage 2 30 minutes post - blister creation (this phase comprised 10 temperature readings recorded at 3 minute intervals) and Stage 3: 5 hours after the 30 minute post-blister period (5 temperature readings recorded at 1 hour intervals).
  • Figure 2 and Table 1 represent the temperature data at: baseline, the end of Stages 1 , 2 and 3 and at the beginning of Stage 3 for both the test and control sites.
  • Table 1 Temperature ranges at baseline, at the end of each stage of data collection data and at the beginning of Stage 3.
  • Control sites The temperatures at the control sites remained relatively constant throughout all three stages of the experiment (mean change in temperature from baseline ⁇ SD: -0.3 ⁇ 1 .4°C, p>0.05).
  • Test sites The number of load-rest cycles required to cause blistering ranged from 2 to 16 cycles (mean ⁇ SD: 6 ⁇ 4 cycles). In terms of time of load application (although separated by 1 minute rest intervals every 2 minutes) the minimum loading time required to initiate blistering was 4min and the maximum loading time 32min (mean ⁇ SD: 12.8 ⁇ 9.8min). Twenty-three participants (77%) blistered within the first 18 min of load application (i.e. 6 load-rest cycles).
  • the mean change from baseline to the point of blister formation was 5.0 ⁇ 2.5 °C. (p ⁇ 0.001 ).
  • the design of the LAM provided the appropriate amount of compression and friction to the skin to generate friction blisters that had the expected blister anatomy (confirmed using ultrasound imaging). This study has provided a description of how skin temperature changes as friction is applied, a blister is created and as healing begins. The scale of changes and consistency across participants suggests that temperature would be a suitable measure of how risk factors (e.g. skin hydration) and prevention or treatment strategies might interfere with underlying risk of blister.
  • risk factors e.g. skin hydration
  • prevention or treatment strategies might interfere with underlying risk of blister.
  • the effect of pre-hydrating the skin on the rate of blister creation was investigated by applying combined friction and compression load to the posterior heel of 20 healthy participants using the mechanical device of the first aspect.
  • Cutomete® 575 (Courage and Khazaka, Colne, Germany)
  • the skin of one randomly allocated foot of each of the 20 participants was hydrated by soaking the foot in water after baseline measurements and prior to compression and shear load using the LAM. Hydration measurements were taken after the hydration process, but before load application to quantify the immediate changes.
  • the contact profile was modified such that the skin was contacted by the rubber contact means in one direction (upwards) only. This was done following additional work highlighting that during in-shoe walking, the shoe has a tendency to rub the heel at the heel strike part of the gait cycle only.
  • the contact means was operated at a rate of 30 passes/min, whereby a pass is defined as a contact point rub.
  • Example 2 The data illustrate that modifying the skin properties prior to application of the compression and friction load influences the rate of inflammation and risk of blister creation.
  • An advantage of the present invention, as demonstrated by Example 2 is that there is a method and apparatus to study and quantify physiological skin changes during the preventative treatment of the early stage formation of a foot blister.
  • Example 3 illustrating the use of the invention, the efficacy of three potentially preventative treatments on the rate of blister creation was investigated in a limited size pilot study by applying combined friction and compression load to the posterior heel of 30 healthy participants using the mechanical device of the first aspect. 10 participants were used for each product type.
  • Examples 1 -3 illustrate how the invention can be used to assess the efficacy of potentially preventative or therapeutic treatments in the context of blister formation, as detailed in the first and second aspect of the invention.
  • acute inflammation i.e. the formation or prevention of blister formation on the foot
  • the principles apply in the context of chronic, lower level and longer-exposure inflammation.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
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  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
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  • Investigating Or Analysing Biological Materials (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

La présente invention concerne un mécanisme d'application de charge destiné à être utilisé dans un procédé de test de l'efficacité d'une préparation ou d'un pansement ou d'un autre produit approprié, pour la prévention d'une inflammation cutanée. Selon l'invention, le mécanisme est utilisé pour générer une force ou une pression, en combinaison avec une friction et un cisaillement, qui conduit à une inflammation cutanée et comprend un moyen de contact pour un frottement contre la peau d'un participant et un moyen de régulation de la vitesse à laquelle le moyen de contact entre en contact avec la peau du participant.
PCT/GB2013/050830 2012-03-30 2013-03-28 Procédé et appareil destinés à tester des traitements d'une inflammation cutanée chronique et aiguë WO2013144641A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2013239470A AU2013239470B2 (en) 2012-03-30 2013-03-28 A method and apparatus for testing chronic and acute skin inflammation treatments
EP13717819.0A EP2836108A1 (fr) 2012-03-30 2013-03-28 Procédé et appareil destinés à tester des traitements d'une inflammation cutanée chronique et aiguë

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB1205646.1 2012-03-30
GB1205646.1A GB2500688B (en) 2012-03-30 2012-03-30 A method and apparatus for testing skin inflammation treatments

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WO2013144641A1 true WO2013144641A1 (fr) 2013-10-03

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EP (1) EP2836108A1 (fr)
AU (1) AU2013239470B2 (fr)
GB (1) GB2500688B (fr)
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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010101621A1 (fr) * 2009-03-02 2010-09-10 Seventh Sense Biosystems, Inc. Dispositifs et procédés d'analyse d'un fluide extractible

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Publication number Priority date Publication date Assignee Title
US5592947A (en) * 1995-05-09 1997-01-14 Universite De Montreal Algometer with pressure intensification rate adjusting and control capabilities
FR2790656B1 (fr) * 1999-03-11 2001-06-01 Centre Techn Ind Mecanique Dispositif et procede de caracterisation de la peau par tribometrie
SE528188C8 (sv) * 2004-10-25 2006-10-31 Vibrosense Dynamics Ab Apparat för identifiering av bibrotaktila tröskelvärden på mekanoreceptorer i huden
US20100234737A1 (en) * 2009-03-12 2010-09-16 Miranda Aref Farage Method for assessing skin irritation using infrared light

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010101621A1 (fr) * 2009-03-02 2010-09-10 Seventh Sense Biosystems, Inc. Dispositifs et procédés d'analyse d'un fluide extractible

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
FARINA HASHMI ET AL: "The formation of friction blisters on the foot: the development of a laboratory-based blister creation model", SKIN RESEARCH AND TECHNOLOGY, vol. 19, no. 1, 14 August 2012 (2012-08-14), pages e479 - e489, XP055065763, ISSN: 0909-752X, DOI: 10.1111/j.1600-0846.2012.00669.x *

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AU2013239470A1 (en) 2014-10-23
GB201205646D0 (en) 2012-05-16
AU2013239470B2 (en) 2017-01-19
EP2836108A1 (fr) 2015-02-18
GB2500688A (en) 2013-10-02
GB2500688B (en) 2016-10-26

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