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GlucoRx Allpresan®diabetic foam creams
This document is for use with decision makers within the NHS. Its aim is to make such individuals aware of the evidence to support the use of GlucoRx Allpresan diabetic foam creams in the UK.
Further information is available from the GlucoRx Head Office.
Tel: 01483 755133
Email: [email protected]
2
PRESCRIBING INFORMATION CAN BE FOUND IN APPENDIX 1
Contents
Summary ...................................................................................................................... 3
Background ................................................................................................................. 5
Dry skin ..................................................................................................................... 5
Foot ulcers ................................................................................................................ 6
Guidance ...................................................................................................................... 6
NICE Guidance ......................................................................................................... 6
SIGN Guidance ......................................................................................................... 6
Unmet need ................................................................................................................. 6
Foam creams ............................................................................................................... 7
Application ................................................................................................................ 7
Patient acceptance and ease of use ......................................................................... 7
Dispensing ................................................................................................................ 7
Place in therapy .......................................................................................................... 7
GlucoRx Allpresan ...................................................................................................... 8
Indication ................................................................................................................ 88
Mechanism of action ................................................................................................. 8
Medical device .......................................................................................................... 8
Clinical evidence ......................................................................................................... 8
Study by Baker et al .................................................................................................. 8
Study by Wigger-Alberti et al .................................................................................... 9
Study by Proksch .................................................................................................... 13
Study by Bristow ..................................................................................................... 13
Budget impact ........................................................................................................... 13
Appendix 1: Prescribing Information ...................................................................... 15
GlucoRx Allpresan® diabetic Foam Cream BASIC .................................................. 15
GlucoRx Allpresan® diabetic Foam Cream INTENSIVE .......................................... 16
References ................................................................................................................. 17
3
Summary
Background
Treating dry skin is a key element of preventing foot ulcers in people with diabetes.1,2
• Diabetes mellitus is among the most common conditions in the UK, with 3.5 million people in the
UK diagnosed with diabetes in 20143
• Up to 80% of people with diabetes suffer from dry skin, which is more vulnerable to breakdown2,4
• Dry skin on a diabetic foot is one of the risk factors for foot ulcer formation.1 About 10% of people
with diabetes will have a foot ulcer at some point in their lives5
• Diabetes is the most common cause of non-traumatic limb amputation, with diabetic foot ulcers
preceding more than 80% of amputations in people with diabetes.5 There are over 135
amputations a week among people with diabetes3
Guidance
• NICE recommends that there is a foot protection service for preventing diabetic foot problems, and
for treating and managing diabetic foot problems in the community. For adults with diabetes, their
risk of developing a diabetic foot problem should be assessed when diabetes is diagnosed and at
least annually thereafter; if any foot problems arise; and on any admission to hospital. For people
at moderate or high risk of developing a diabetic foot problem, the foot protection service must
give advice about, and provide, skin and nail care of the feet5
• SIGN recommends that all patients with diabetes should be screened at least annually to assess
their risk of developing a foot ulcer and those with active diabetic foot disease should be referred
to a multidisciplinary diabetic foot service team6
Unmet need
Emollient creams should not be applied between the toes.7
• Treating dry skin with foam creams help stabilise the epidermal barrier and improve symptoms8
• Dry skin on a diabetic foot has traditionally been treated with an emollient9
• Conventional creams should not be applied between the toes because this can cause the skin to
become too moist and lead to an infection developing10
• Daily application of foot moisturisers by people with diabetes may stop after 2-3 weeks of
commencement, due to a perceived lack of skin moisturising effect11
Foam creams
GlucoRx Allpresan diabetic foam creams can be spread evenly, including into the spaces between
toes.12
• The foam creams are convenient and easy for patients to use, especially those who may have
mobility problems.8 The foam cream is readily absorbed, can be spread easily and is not sticky8
• The foam creams are dispensed from a spray can in a clean and hygienic way, allowing for small
dosages and protection of the product from contamination, which is advantageous over creams
dispensed from a tube, pot or pump dispenser12
Place in therapy
GlucoRx Allpresan diabetic foam cream is the only clinically formulated foam cream to prevent dry
cracked skin and calluses on diabetic feet.
• GlucoRx Allpresan diabetic foam cream boosts the skin’s barrier function, thus protecting against
skin infections and ulceration12–15
• It is the only foam cream to be clinically approved in the UK for use on the entire foot including
between the toes12,14,16
4
• GlucoRx Allpresan diabetic foam cream is quick to apply, non-greasy and footwear can be put on
immediately after application13
Indication
• GlucoRx Allpresan diabetic foam cream BASIC (5% urea) is a medical device for the specific
treatment of dry and sensitive foot skin in patients with diabetes mellitus14
• GlucoRx Allpresan diabetic foam cream INTENSIVE (10% urea) is a medical device for the
specific treatment for very dry to chapped foot skin in patients with diabetes mellitus16
Mechanism of action GlucoRx Allpresan diabetic foam creams contains a unique complex of
moisturising agents: pentavitin®, panthenol and urea.14,16
• Pentavitin® is a moisturiser which contains naturally-occurring carbohydrates. Pentavitin® binds
strongly to the skin and has a highly-effective moisture-regulating capability17
• Panthenol acts as a moisturiser, improving stratum corneum hydration, reducing transepidermal
water loss and maintaining skin softness and elasticity18
• Urea is a keratin softener and hydrating agent used in the treatment of dry, scaling conditions.19
Urea increases the moisture content of the keratinous layer of the skin, making the skin softer and
more supple, as well as relieving itchiness16
• When the foam is applied, it forms a two-dimensional protective mesh on the skin, so the skin is
able to breathe and is protected from external influences14,16 Medical device
GlucoRx Allpresan diabetic foam creams are class IIa medical devices.20
• A medical device is used for the prevention, treatment or alleviation of disease and its main action
is not pharmacological21
• Clinical data for a medical device means the safety and/or performance generated from the use of
the device. Clinical data are sourced from clinical investigation of the actual medical device or a
similar, equivalent medical device21
Clinical evidence
Baker et al examined the effects of GlucoRx Allpresan-3, containing 10% urea in 26 patients with
diabetes and dry skin on both feet. GlucoRx Allpresan-3 does not contain the moisturising complex of
pentavitin®, panthenol and urea but it was still considered superior to the control moisturisers in terms
of application, absorption, rehydration and overall effectiveness by the majority of patients. More than
83% of participants rated GlucoRx Allpresan-3 ‘high’ for ease of application, absorption, post-
application skin feel, improved skin hydration and overall satisfaction. Most (96%) participants
preferred and wished to continue using GlucoRx Allpresan-3 over their control moisturiser.11
Wigger-Alberti et al evaluated the effects of GlucoRx Allpresan diabetic foam cream intensive in
patients with diabetes and dry/sensitive skin and compared with two other GlucoRx Allpresan foam
creams.13
• After twice daily application for 4 weeks, both dermatological and subjective assessments showed
an improvement in symptoms, with many symptoms improving after 1 week of use
• The foam cream formulations showed a moisturising effect while no clinically significant increase
of bacterial colonisation was observed in the interdigital area of the foot
• All three products were well accepted by the patients, with 80% preferring a foam cream to a
conventional lotion or cream and ≥85% of them more willing to carry out daily foot care with a foam
cream
• The majority of patients (>90%) assessed the improvement in their skin condition as very good or
good and 80% preferred how the foam cream was applied and absorbed to that of a conventional
lotion or cream
• Over 95% perceived the risk of slipping to be moderate to negligible
5
Proksch carried out a study in 20 patients with diabetes with GlucoRx Allpresan diabetic foam cream
Intensive.22
• Skin hydration on the forearm increased by 32.2% after 14 days and by 38.7% after 28 days, and
by 47.6% and 49.5% respectively on the foot/ankle
• Skin smoothness was significantly increased on the test areas (p<0.05), increasing by 9.7% after
14 days and by 17.5% after 28 days on the forearm
• After both 14 and 28 days of treatment, a significant (p<0.05) improvement in satisfaction with the
skin condition and in experienced pruritus was seen with respect to the evaluated treatment area
In a 14-day patient and podiatrist evaluation study, GlucoRx Allpresan diabetic foam cream
INTENSIVE (10% urea) applied to one foot (test foot was found to be as effective as a non-foaming
10% urea cream applied to the other foot (control foot) (n=20 patients with dry feet/heels).23
• At day 14, there was a significant reduction in overall dryness scores for both feet in all patients
(p<0.000 for changes in mean dryness scores from baseline in each foot). Efficacy of the test
product was rated by clinicians as good (35%) to excellent (45%) and tolerability as good (15%) to
excellent (85%) in all participants23
• Patient evaluations showed overall a high level of satisfaction with the product, showing overall
agreement with the benefits of the test product23
• Participating podiatrists felt that a foam cream promoted less wastage and that owing to the
texture and application of the foam, GlucoRx Allpresan foam cream could make an excellent post-
operative application to be kept in the surgery for patients following podiatry treatment, as it is
clean and quick to apply and didn’t need to be worked in as much as creams, saving practitioners
time at the end of a consultation23
Budget impact
People using GlucoRx Allpresan diabetic foam cream INTENSIVE (10% urea) required only 0.11g of
product to cover the same area covered by 0.24g of a non-foaming 10% urea emulsion.24
Less than half the amount of GlucoRx Allpresan diabetic foam cream INTENSIVE is needed per
application compared with a non-foaming 10% urea emulsion.16,24 In another study in 20 subjects, on
average, 35mL of GlucoRx Allpresan diabetic foam cream INTENSIVE was
23
required for two weeks’ worth of treatment.
Background
Diabetes mellitus is among the most common chronic conditions in the UK and its prevalence is
increasing.25,5 In 2014, there were 3.5 million people in the UK diagnosed with diabetes, and by 2025,
it is estimated that 5 million people will have diabetes in the UK.3 The majority of people with diabetes
have type 2 diabetes (90%).3
Dry skin
If skin is abnormally dry, fissures can develop, the skin loses its elasticity and flexibility and ability to
withstand trauma, resulting in skin breakdown and subsequent infection.26 Treating dry skin is a key
element of preventing skin breakdown and foot ulcers in people with diabetes.1,27
A healthy skin barrier is crucial to protect against mechanical, microbial and chemical damage.8 Up to
80% of people with diabetes suffer from dry skin.4,8 In people with diabetes, neuropathy causes
decreased sweating and the lipid matrix of the skin is altered; these can result in deterioration of the
epidermal protective function, which manifests as an impaired stratum corneum (the outermost layer
of the epidermis), or dry skin, as well as scaling and pruritus.2,8,12 This makes the skin more
vulnerable to breakdown.2 Dry skin on a diabetic foot is one of the risk factors for foot ulcer formation.1
6
Foot ulcers
About 10% of people with diabetes will have a diabetic foot ulcer at some point in their lives.5 Foot
ulceration usually precedes lower limb amputation, due to a combination of nerve damage
(neuropathy), which reduces sensation in the lower limbs and feet, and impaired circulation.2,3,7
Diabetic foot ulcers precede more than 80% of amputations in people with diabetes.5 There are over
100 amputations a week among people with diabetes.3 Ulceration and amputation reduce quality of
life and are associated with increased mortality.28 Foot ulcers are painful and require considerable
time spent on clinic visits, hospitalisation and wound dressing changes.28 Amputations can result in
long-term changes to mobility, living conditions and relationships.28
People with diabetes are also susceptible to foot infections, mainly because of neuropathy, poor
circulation and reduced neutrophil function.5,29 Once the skin is broken, the infection can spread
rapidly to underlying tissues, causing extensive tissue destruction and direct threat to the affected
limb.7,28,29 Infection is the main reason for major amputation in neuropathic feet and a frequent cause
of amputation in ischaemic and neuro-ischaemic feet.28
Guidance
NICE Guidance
NICE state that a foot protection service for preventing diabetic foot problems, and for treating and
managing diabetic foot problems in the community should be in place. There should also be a
multidisciplinary foot care service for managing diabetic foot problems in hospital and in the
community that cannot be managed by the foot protection service.5
For adults with diabetes, their risk of developing a diabetic foot problem should be assessed: when
diabetes is diagnosed and at least annually thereafter; if any foot problems arise; and on any
admission to hospital, and if there is any change in their status while they are in hospital.5
When examining the feet of a person with diabetes, their shoes, socks, bandages and dressings must
be removed and both feet examined for any signs of the following risk factors: neuropathy, limb
ischaemia, ulceration, callus, infection and/or inflammation, deformity, gangrene, Charcot arthropathy.
A patient at low risk of developing a diabetic foot problem or needing an amputation indicates no risk
factors present; moderate risk indicates one risk factor present and high risk indicates previous
ulceration or amputation, on renal replacement therapy or more than one risk factor present.5
For people at moderate or high risk of developing a diabetic foot problem, the foot protection service
must give advice about, and provide, skin and nail care of the feet. Information should be oral and
written and include basic foot care advice and the importance of foot care.5
The Quality and Outcome Framework (England) contains the following indicator for diabetes:30
DM012. The percentage of patients with diabetes, on the register, with a record of a foot
examination and risk classification: 1) low risk (normal sensation, palpable pulses), 2) increased
risk (neuropathy or absent pulses), 3) high risk (neuropathy or absent pulses plus deformity or skin
changes in previous ulcer) or 4) ulcerated foot within the preceding 12 months
SIGN Guidance
All patients with diabetes should be screened at least annually to assess their risk of developing a foot
ulcer.6 Those with active diabetic foot disease should be referred to a multidisciplinary diabetic foot
service team.6
Unmet need
Dry skin on a diabetic foot makes it vulnerable to breakdown and ulcer formation; this can be
complicated by infections.2,26 Microvascular disease can cause poor blood circulation to the skin and
can slow down healing of broken skin.31
7
Intensive daily foot care must include an appropriate regime to replenish the skin’s moisture and fat
content and create a protective layer against the outside environment. Dry skin on a diabetic foot has
traditionally been treated with an emollient, but conventional creams should not be applied between
the toes because this can cause the skin to become too moist and lead to an infection developing.7,9,10
Adherence to daily application of moisturisers is often short-lived among people with diabetes, with
treatment stopping 2-3 weeks after starting due to a perceived lack of skin moisturising effect.11
Effective skin care needs to supply moisture and lipids and restore the epidermal protective function.12
The ideal skin-care product would lead to a gradual increase in hydration over a period of time and a
decrease in trans-epidermal water loss.12 GlucoRx Allpresan diabetic foam creams are specifically
formulated to treat dry and very dry diabetic skin and can be used to cover and protect the entire foot,
from heel to toe, including between the toes.12,14,16
Foam creams
Treating dry skin with GlucoRx Allpresan diabetic foam creams help stabilise the epidermal barrier
and improve symptoms.8 The water content of the foam cream evaporates from the skin surface,
converting the product into a lipophilic form, resulting in a higher concentration of the active
substance, urea, and better absorption through the skin.12 The foam character is not lost during the
drying process: microscopic foam bubbles are present 30 minutes after application and drying,
implying that no occluding cream layer is formed and that trans-epidermal water exchange between
the epidermis and the environment is maintained.12 GlucoRx Allpresan diabetic foam creams can be
applied to and will protect the entire foot, from heel to toe, including between the toes.12,14,16
Application
GlucoRx Allpresan diabetic foam creams are easy to apply and can be spread evenly, including into
difficult-toreach sites such as the spaces between toes.12 They are convenient and easy for patients
to use, especially those who may have mobility problems.8 The foam cream is readily absorbed, can
be spread easily and is not sticky or greasy.8,14,16
Patient acceptance and ease of use
Despite the treatment of dry skin being a key element to preventing foot ulcers and infection, it is often
neglected.1 Patients complain that emollients make their feet slippery and they do not want to slip or
fall, or that they make their footwear dirty.1 In a four-week study assessing ease of use of foam
creams, 85% of 92 people with diabetes confirmed that the foam cream was rapidly and completely
absorbed and 82.5% reported that they could put on their socks without any problems immediately
after applying the foam cream.1
Dispensing
GlucoRx Allpresan diabetic foam creams are dispensed from a spray can in a clean and hygienic way,
allowing for small dosages and protection of the product from contamination, which is advantageous
over creams dispensed from a tube. The foam develops as soon as the emulsion is ejected out of the
aerosol nozzle. No preservatives are needed and sensitive ingredients are protected by the airtight
packaging.12
Place in therapy
GlucoRx Allpresan diabetic foam cream is formulated to prevent dry cracked skin and calluses on
diabetic feet. GlucoRx Allpresan diabetic foam creams are the only products to be clinically approved
in the UK for use on the entire diabetic foot including between the toes.12,14,16 GlucoRx Allpresan
diabetic foam cream boosts the skin’s barrier function, thus protecting against skin infections and
ulceration.12–15
GlucoRx Allpresan diabetic foam cream forms a breathable protective coating with a specific formula
that strengthens and repairs the skin barrier.14,16 GlucoRx Allpresan diabetic foam cream is quick to
apply, nongreasy and footwear can be put on immediately after application.13
8
GlucoRx Allpresan
Indication
GlucoRx Allpresan diabetic foam cream BASIC (5% urea) is a medical device for the specific
treatment of dry and sensitive foot skin in patients with diabetes mellitus. GlucoRx Allpresan diabetic
foam cream Basic reduces roughness, counteracts pressure marks and smoothes the skin.14
GlucoRx Allpresan diabetic foam cream INTENSIVE (10% urea) is a medical device for the specific
treatment for very dry to chapped foot skin in patients with diabetes mellitus. GlucoRx Allpresan
diabetic foam cream INTENSIVE counteracts pressure marks and helps prevent calluses.16
Both GlucoRx Allpresan diabetic foam creams can be used on the entire foot, from heel to toe,
including between the toes and around wound edges.12,14,16 Only a small amount is required, about
the size of a hazelnut or walnut depending on the size of the area to be treated. The foam cream is
easy to rub in and can be applied quickly without leaving behind a greasy film. Footwear can be put
on immediately after use.14,16
Mechanism of action
GlucoRx Allpresan diabetic foam creams contains a unique complex of moisturising agents:
pentavitin®, panthenol and urea.14,16 When the foam is applied, it forms a two-dimensional protective
mesh on the skin, so the skin is able to breathe and is protected from external influences.14,16
GlucoRx Allpresan diabetic foam cream boosts the skin’s barrier function, thus protecting against skin
infections and ulceration.12–15
• Pentavitin® is a moisturiser which contains naturally occurring carbohydrates, similar to those
found in the stratum corneum of skin.17 Pentavitin® binds strongly to the skin and cannot be
washed off easily, so moisture remains in the skin, protecting against dehydration.16,17 Pentavitin®
is removed by natural skin shedding. It has a highly effective moisture-regulating capability, with
long-lasting moisture-binding and moisture retention17
• Panthenol acts as a moisturiser, improving stratum corneum hydration, reducing transepidermal
water loss and maintaining skin softness and elasticity. Promotion of regeneration of the skin
barrier, which is necessary for wound healing, has been observed with panthenol18
• Urea is a keratin softener and hydrating agent used in the treatment of dry, scaling conditions.19
Urea is also used as a proteolytic agent for wound debridement.32 The hydrating properties of
urea, used in concentrations up to 10%, offer clinical benefits to people with dry skin.32 It increases
the moisture content of the keratinous layer of the skin, making the skin softer and more supple, as
well as relieving itchiness.16 Trans-epidermal water loss, used to assess skin hydration, is reduced
by urea used on both dry and healthy skin32
Medical device
GlucoRx Allpresan diabetic foam creams are class IIa medical devices.20 A medical device is used for
the prevention, treatment or alleviation of disease and does not achieve its main action by
pharmacological activity, but may be assisted in its function by such means.21 Clinical data for a
medical device means the safety and/or performance generated from the use of the device.21 Clinical
data are sourced from clinical investigation of the actual medical device or a similar, equivalent
medical device or published/unpublished reports on other clinical experience of either the device in
question or a similar device for which equivalence can be demonstrated.21 There are a number of
clinical trials which support the use of GlucoRx Allpresan diabetic foam cream.11,13,22
Clinical evidence
Study by Baker et al
A pilot study carried out in the UK examined the effects of GlucoRx Allpresan-3 foam cream,
containing 10% urea, in 26 patients with diabetes with dry skin on both feet and neuropathy. Three
clinical parameters were measured at baseline and endpoint: (1) skin dryness, (2) skin flexibility and
(3) callus formation, as well as patient satisfaction.
9
The clinical parameters were assessed on a five-point scale, where 1 = normal, supple plantar skin
without dryness or callus and 5 = extremely dry, very inflexible plantar skin with thick callus. All
participants were asked to apply GlucoRx Allpresan-3 to the allocated test foot, and their regular
moisturising cream to the contra-lateral non-test foot. Each moisturiser (test and control) was to be
applied to its assigned foot, over the whole surface, but not between the toes, twice daily for 2 weeks.
The control moisturisers were aqueous cream, E45 cream, Diprobase and Unguentum Merck.11
For both skin dryness and skin flexibility, GlucoRx Allpresan 3 was shown to be significantly more
effective than the control moisturisers by the end of the 2-week study period (p=0.0001 for both
parameters, Table 1). For callus formation, there was a small reduction seen with GlucoRx Allpresan-
3 compared with the control moisturisers, although it was not statistically significant.11
Table 1: Mean scores for each of the clinical parameters tested11
GlucoRx Allpresan-3 Control moisturiser
Baseline Week 2 Score
difference Baseline Week 2 Score
difference
Skin dryness 3.81 1.73 2.08 3.77 3.46 0.31
Skin flexibility 3.42 2.19 1.23 3.42 3.35 0.07
Callus
formation 2.88 3.23 –0.35 3.04 3.12 –0.08
GlucoRx Allpresan-3 does not contain the moisturising complex of urea, pentavitin® and panthenol but
it was still considered superior to the control moisturisers in terms of application, absorption,
rehydration and overall effectiveness by the majority of patients. More than 83% of participants rated
GlucoRx Allpresan-3 ‘high’ for ease of application, absorption, post-application skin feel, improved
skin hydration and overall satisfaction. Most (96%) participants preferred and wished to continue
using GlucoRx Allpresan-3 over their control moisturiser.11
Study by Wigger-Alberti et al
The skin-moisturising properties and potential application in the interdigital spaces of three foam
creams was tested in 60 patients with type 1 or type 2 diabetes. Patients applied one of three foam
creams twice a day for 29 days to their feet, including the interdigital area: GlucoRx Allpresan diabetic
Intensive (n=20), GlucoRx Allpresan diabetic Intensive Care with microsilver (n=20) and GlucoRx
Allpresan diabetic Intensive Care with polyhexanide (n=20).13
Patients
Two-thirds (66.7%) of patients enrolled were female, and the overall mean age was 58.8 years.13
Assessments
Interdigital swabs were taken and skin humidity was assessed by corneometry on day 1. Swabs were
taken from the interdigital spaces between toes 1 and 2 and between toes 3 and 4. Clinical and
subjective assessments and measurements of skin humidity were conducted on days 8, 15 and 29,
and interdigital swabs taken on day 29.13
Dermatological assessments were skin redness, dryness, desquamation, cracking, oedema, papules,
blisters, oozing skin areas, and skin erosions. Subjective assessments were made on a 4-point scale
ranging from ‘not perceived’ to ‘very strongly perceived’ for itching, stinging, burning sensation,
dryness and tightness.13
Results Bacterial counts
Application of the foam cream between the interdigital spaces did not increase gram-positive bacteria.
The bacterial colonisation had an absolute log10 value of 4.6 before treatment with GlucoRx Allpresan
diabetic Intensive and 4.8 after 29 days. Results for all three groups are shown in figure 1. The
colonisation of the interdigital spaces with gram-negative bacteria was nearly zero both before the
start of the application (day 1) and after completion of the study (day 29).13
10
Figure 1: Mean colonisation of the interdigital spaces with gram-positive bacteria before (day 1) and
after 4 weeks of application (day 29)13
Adapted from Wigger-Alberti W et al. Cosmet Med 2015;1(15):30–35.
Corneometry
Corneometry measurements indicated an increase in skin moisture after 8 days in relation to day 1,
which was maintained to day 29 (Table 2 and Figure 2).13
Table 2: Mean corneometry measurements13
GlucoRx Allpresan
diabetic Intensive
GlucoRx Allpresan diabetic
Intensive Care with
microsilver
GlucoRx Allpresan diabetic
Intensive Care with
polyhexanide
Day 1 23.0 a.u. 20.9 a.u. 24.0 a.u.
Day 8 34.7 a.u. 35.7 a.u. 33.2 a.u.
Day 15 35.9 a.u. 38.3 a.u. 37.4 a.u.
Day 29 37.4 a.u. 36.6 a.u. 38.5 a.u.
11
Figure 2: Development of moisture content in the stratum corneum in relation to the application of
different foam creams13
Adapted from Wigger-Alberti W et al. Cosmet Med 2015;1(15):30–35.
Dermatological assessments
Corresponding to the increase of skin hydration, the skin dryness was markedly reduced during the
4week treatment period (Figure 3). Skin redness, desquamation, oedema and cracking were very mild
from the start of the application. No papules, blisters or skin erosions were present in any patient
during the study.13
Figure 3: Course of the parameter ‘dryness’ evaluated by a dermatologist in relation to the use of
different foam creams over a study period of 4 weeks13
Adapted from Wigger-Alberti W et al. Cosmet Med 2015;1(15):30–35.
12
Subjective assessments
The subjective assessments found that:13
• Itching was reduced by around one point, so that ≥90% of all patients reported no itched after 2
weeks of treatment
• Stinging and burning sensation was negligibly weak in all treatment groups
• Skin condition that was assessed as dry at the beginning of the study period got continuously
better during the study (Figure 4)
• A marked improvement in tightness was seen by day 8 and remained at this improved level during
the rest of the study
Figure 4: Subjectively-assessed skin dryness in relation to the use of different foam creams over 4
weeks13
Adapted from Wigger-Alberti W et al. Cosmet Med 2015;1(15):30–35.
The analysis of the subjective questionnaire found that after application of the foam creams:13
• Over 80% of patients described the improvement of their skin condition as good or very good
• Over 80% assessed the tolerability of the product used as very good
• 95% of those using GlucoRx Allpresan diabetic Intensive and 90% of the users of the other two
groups perceived the application to be very good or good
• 80% of the users described absorption of the foam cream in comparison with other creams and
lotions as very good or good
• Over 95% of users perceived the risk of slipping as moderate to negligible
• 75% to 90% of users declared they could put their socks on after the application of the foam cream
quickly or very quickly
• 80% of users preferred the foam cream over other creams and lotions
• More than 85% of users reported that the option of a foam cream increased their willingness to
conduct daily foot care
• All participants would recommend the foam cream they used to other diabetic patients
13
Safety
No adverse effects of the foam creams occurred during the study.13
Summary
All three foot foam cream formulations used over the foot and between the toes showed a
moisturising effect while no increase of bacterial colonisation was observed. These effects can be
attributed to the particular texture of the foam cream used and not to the inclusion of the antibacterial
components microsilver or polyhexanide. Both dermatological and subjective assessments showed
an improvement in symptoms over the 4-week treatment period, with many symptoms improving after
1 week of use. All three products were well accepted by the patients, with 80% preferring a foam
cream to a conventional lotion or cream and ≥85% of them more willing to carry out daily foot care
with a foam cream. The majority of patients (>80%) assessed the improvement in their skin condition
as very good or good and ≥85% preferred how the foam cream was applied and absorbed to that of a
conventional lotion or cream. A reduced risk of slipping after application of the foam cream was
assessed.13
Study by Proksch
An efficacy test and application test was carried out on GlucoRx Allpresan diabetic foam cream
Intensive in 20 patients with diabetes. The foam cream was applied twice a day for 28 days to two
areas: inside of the forearm and the foot/ankle, with an untreated area on the inside of the forearm
acting as a control. The foam cream was found to significantly increase skin hydration on both test
areas in comparison with the control area (p<0.05). Skin hydration on the forearm following GlucoRx
Allpresan foam cream use increased by 32.2% after 14 days and by 38.7% after 28 days, and by
47.6% and 49.5% respectively on the foot/ankle. Skin smoothness on the forearm was also
significantly increased on the test areas in comparison with the control area (p<0.05): by 9.7% after
14 days and by 17.5% after 28 days. After both 14 and 28 days of treatment, a significant (p<0.05)
improvement in satisfaction with the skin condition and in experienced pruritus was seen with respect
to the evaluated treatment area.22
Study by Bristow
GlucoRx Allpresan diabetic foam cream INTENSIVE (10% urea) was found to be as effective as a
non-foaming 10% urea cream in patient and podiatrist evaluation study (n=20 patients with dry
feet/heels). GlucoRx Allpresan foam cream was applied to one foot (test foot) and a non-foaming 10%
urea cream was applied to the other foot (control foot), both applied twice daily for 14 days. At
baseline there was no significant difference in the clinically measured dry skin score between the test
and control foot overall.23
When the feet were assessed at day 14, there was a significant reduction in overall dryness scores for
both feet in all patients. Mean dryness scores in the test foot reduced from 5.90 at baseline to 2.00 at
day 14 (p<0.000). In the control foot mean dryness scores reduced from 5.90 at baseline to 2.10 at
day 14 (p<0.000). Efficacy of the test product was rated by clinicians as good (35%) to excellent
(45%) and tolerability as good (15%) to excellent (85%) in all participants.23
Patient evaluations showed overall a high level of satisfaction with the product, showing overall
agreement with the benefits of the test product. Participating podiatrists felt that a foam cream
promoted less wastage. They also felt that owing to the texture and application of the foam, GlucoRx
Allpresan foam cream could make an excellent post-operative application to be kept in the surgery for
patients following podiatry treatment, as it is clean and quick to apply and didn’t need to be worked in
as much as creams, saving practitioners time at the end of a consultation.23
Budget impact
Foot problems in people with diabetes have a significant financial impact on the NHS through primary
care, community care, outpatient costs, increased bed occupancy and prolonged stays in hospital. It
is estimated that around £650 million (or £1 in every £150 that the NHS spends) is spent on foot
ulcers or amputations each year.5
People using GlucoRx Allpresan diabetic foam cream INTENSIVE (10% urea) required only 0.11g of
product to cover the same area covered by 0.24g of a non-foaming 10% urea emulsion.24
14
Less than half the amount of GlucoRx Allpresan diabetic foam cream INTENSIVE is needed per
application compared with a non-foaming 10% urea emulsion.16,24
In another study in 20 subjects, on average, 35mL of GlucoRx Allpresan diabetic foam cream
INTENSIVE was required for two weeks’ worth of treatment.23
GlucoRx Allpresan diabetic foam cream is the only urea-containing preparation specifically indicated
for use in people with diabetes.33
Table 3: Basic NHS list price33,34
Product Indication Pack size
GlucoRx Allpresan diabetic
foam cream BASIC
Dry, sensitive foot skin in diabetic
patients
125mL: £5.50
300mL: £9.75
GlucoRx Allpresan diabetic
foam cream INTENSIVE
Very dry to chapped foot skin in
diabetic patients
125mL: £5.50
300mL: £9.75
15
Appendix 1: Prescribing Information
GlucoRx Allpresan® diabetic Foam Cream
BASIC
Intended purpose
GlucoRx Allpresan® diabetic Foam Cream BASIC is a
medical device for the specific treatment of dry and
sensitive foot skin in patients with diabetes mellitus.
Its special properties also make it suitable for the
treatment of wound edges. GlucoRx Allpresan®
diabetic Foam Cream BASIC boosts the skin’s barrier
function, thus protecting against skin infections and
ulcerations.
Properties
The specially designed active formula forms a
breathable, two-dimensional protective coating. It
strengthens the barrier function, protects against
external impacts, and reduces mechanical stresses
such as friction without impairing natural skin
function. The skin is optimally supplied with
moisture, and Pentavitin® also guards against
moisture loss. Reduces roughness, counteracts
pressure marks and smooths the skin.
Use
Mornings and evenings, apply an amount about the
size of a hazelnut or walnut to the affected areas of
the feet. Also beneficial for use between the toes.
GlucoRx Allpresan® diabetic Foam Cream offers
excellent convenience in use, since it is very easy to
rub in. It can be applied very quickly without leaving
behind an unpleasant greasy film. There is reduced
risk of slipping, and you can put on your stockings –
even compression stockings – immediately after use.
Shake well before each use, and hold the container
upright when applying (please ensure the can is in the
upright position and do not tilt during use!)
Never apply to the eye region or mucus
membranes, or in open wounds. Do not use
GlucoRx Allpresan® diabetic Foam Cream BASIC
once the expiration date has passed. For external
use only.
Side effects
The use of GlucoRx Allpresan® diabetic may
cause temporary skin irritation (e.g. burning, itching,
reddening), especially if the foam cream containing
urea is applied to very irritated areas of skin.
Contraindications
Do not use if there is known sensitivity to
any of the ingredients. Do not use on infants or
children under the age of 5 years. Interactions
Urea can increase the release of other active
ingredients from other external-use products, and
promote their penetration into the skin. Please ask
your doctor or pharmacist if you are using other
external-use products.
Ingredients
Aqua, Butane, Urea, Decyl Oleate,
Octyldodecanol, Cetearyl Alcohol, Propane,
Stearic Acid, Propylene Glycol, Glycerin, Glyceryl
Stearate, Panthenol, Saccharide Isomerate
(Pentavitin®), Undecyl Alcohol, Allantoin,
Potassium Lauroyl Wheat Amino Acids, Palm
Glycerides, Capryloyl Glycine, Sodium Lauroyl
Sarcosinate, Sodium Citrate, Citric Acid. Pentavitin® made by Pentapharm Ltd.
Points to consider
Warning. Pressurised container: May burst if
heated. Keep away from heat, hot surfaces, sparks,
open flames and other ignition sources. No smoking.
Do not spray on an open flame or other ignition
source. 9 % by mass of the contents are flammable.
Do not pierce or burn, even after use. Protect from
sunlight. Do not expose to temperatures exceeding 50
°C/122 °F. Keep out of reach of children. Use only in
well-ventilated areas.
16
Intended purpose
GlucoRx Allpresan® diabetic Foam Cream INTENSIVE
is a medical device for the specific treatment of very
dry to chapped foot skin in patients with diabetes
mellitus. Its special properties also make it suitable for
the treatment of wound edges. GlucoRx Allpresan®
diabetic Foam Cream INTENSIVE promotes the
healing process and supports recovery of the
damaged skin barrier.
Properties
The specially designed active formula forms a
breathable, two-dimensional protective coating. It
strengthens the barrier function, protects against
external impacts, and reduces mechanical stresses
such as friction without impairing natural skin function.
The skin is optimally supplied with moisture, and
Pentavitin® also guards against moisture loss.
Relieves itching, counteracts pressure marks, and
also helps to prevent calluses.
Use
Mornings and evenings, apply an amount about the
size of a hazelnut or walnut to the affected areas of
the feet. Also beneficial for use between the toes.
GlucoRx Allpresan® diabetic Foam Cream offers
excellent convenience in use, since it is very easy to
rub in. It can be applied very quickly without leaving
behind an unpleasant greasy film. There is reduced
risk of slipping, and you can put on your stockings –
even compression stockings – immediately after
use. Shake well before each use, and hold the
container upright when applying (please ensure the
can is in the upright position and do not tilt during
use!)
Never apply to the eye region or mucus
membranes, or in open wounds. Do not use
GlucoRx Allpresan® diabetic Foam Cream
INTENSIVE once the expiration date has passed.
For external use only.
Side effects
The use of GlucoRx Allpresan® diabetic
may cause temporary skin irritation (e.g. burning,
itching, reddening), especially if the foam cream
containing urea is applied to very irritated areas
of skin. Contraindications
Do not use if there is known sensitivity to any
of the ingredients. Do not use on infants or children
under the age of 5 years. Interactions
Urea can increase the release of other active
ingredients from other external-use products, and
promote their penetration into the skin. Please ask
your doctor or pharmacist if you are using other
external-use products.
Ingredients
Aqua, Urea, Butane, Decyl Oleate,
Octyldodecanol,Cetearyl Alcohol, Propane,
Stearic Acid, Propylene Glycol, Glycerin,
Glyceryl Stearate, Panthenol, Saccharide Isomerate
(Pentavitin®), Undecyl Alcohol,
Allantoin, Potassium Lauroyl Wheat Amino Acids,
Palm Glycerides, Capryloyl Glycine, Sodium Lauroyl
Sarcosinate, Sodium Citrate, Citric Acid.
Pentavitin® made by Pentapharm Ltd.
Points to consider
Warning. Pressurised container: May burst if
heated. Keep away from heat, hot surfaces, sparks,
open flames and other ignition sources. No
smoking. Do not spray on an open flame or other
ignition source. 9 % by mass of the contents are
flammable. Do not pierce or burn, even after use.
Protect from sunlight. Do not expose to
temperatures exceeding 50 °C/122 °F. Keep out of
reach of children. Use only in well-ventilated areas.
GlucoRx Allpresan® diabetic Foam Cream
INTENSIVE
17
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