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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 Allpresan diabetic foam creams in the UK.
Further information is available from the Neubourg pharma Medical Information Department.
Tel: 01483 238209.
Email: [email protected]
Job number: ALL-022(2) Date of preparation: August 2015
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Contents
Summary ................................................................................................................... 3
Background .............................................................................................................. 6
Dry skin .................................................................................................................. 6
Foot ulcers ............................................................................................................. 6
Guidance ................................................................................................................... 6
NICE Guidance ...................................................................................................... 6
SIGN Guidance ...................................................................................................... 7
Unmet need ............................................................................................................... 7
Foam creams ............................................................................................................ 7
Application ............................................................................................................. 7
Patient acceptance and ease of use ...................................................................... 7
Dispensing ............................................................................................................. 8
Place in therapy ........................................................................................................ 8
Allpresan ................................................................................................................... 8
Indication ................................................................................................................ 8
Mechanism of action .............................................................................................. 8
Medical device ....................................................................................................... 9
Clinical evidence ...................................................................................................... 9
Study by Baker et al ............................................................................................... 9
Study by Wigger-Alberti et al ................................................................................ 10
Study by Proksch ................................................................................................. 14
Budget impact ........................................................................................................ 15
Appendix 1: Prescribing Information ................................................................... 16
References .............................................................................................................. 18
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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 a prevalence of 6.0% in adults.3,4 In 2013 there were almost 2.9 million people in the UK diagnosed with diabetes5
Up to 80% of people with diabetes suffer from dry skin, which is more vulnerable to breakdown2,6
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 100 amputations a week among people with diabetes4
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 team7
Unmet need
Emollient creams should not be applied between the toes.8
Treating dry skin with foam creams help stabilise the epidermal barrier and improve symptoms9
Dry skin on a diabetic foot has traditionally been treated with an emollient10
Conventional creams should not be applied between the toes because this can cause the skin to become too moist and lead to an infection developing11
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 effect12
Foam creams
Allpresan diabetic foam creams can be spread evenly, including into the spaces between toes.13
The foam creams are convenient and easy for patients to use, especially those who may have mobility problems.9 The foam cream is readily absorbed, can be spread easily and is not sticky9
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 dispenser13
Place in therapy
Allpresan diabetic foam cream is the only clinically formulated foam cream to prevent dry cracked skin and calluses on diabetic feet.
Allpresan diabetic foam cream boosts the skin’s barrier function, thus protecting against skin infections and ulceration13–16
It is the only foam cream to be clinically and medically approved in the UK for use on the entire foot including between the toes15,17
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Allpresan diabetic foam cream is quick to apply, non-greasy and footwear can be put on immediately after application14
Indication
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 mellitus15
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 mellitus17
Mechanism of action
Allpresan diabetic foam creams contains a unique complex of moisturising agents: pentavitin®, panthenol and urea.15,17
Pentavitin® is a moisturiser which contains naturally-occurring carbohydrates. Pentavitin® binds strongly to the skin and has a highly-effective moisture-regulating capability18
Panthenol acts as a moisturiser, improving stratum corneum hydration, reducing transepidermal water loss and maintaining skin softness and elasticity19
Urea is a keratin softener and hydrating agent used in the treatment of dry, scaling conditions.20 Urea increases the moisture content of the keratinous layer of the skin, making the skin softer and more supple, as well as relieving itchiness17
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 influences15,17
Medical device
Allpresan diabetic foam creams are class IIa medical devices.21
A medical device is used for the prevention, treatment or alleviation of disease and its main action is not pharmacological22
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 device22
Clinical evidence
Baker et al examined the effects of Allpresan-3, containing 10% urea in 26 patients with diabetes and dry skin on both feet. 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 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 Allpresan-3 over their control moisturiser.12
Wigger-Alberti et al evaluated the effects of Allpresan diabetic foam cream intensive in patients with diabetes and dry/sensitive skin and compared with two other Allpresan foam creams.14
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
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
Over 95% perceived the risk of slipping to be moderate to negligible
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Proksch carried out a study in 20 patients with diabetes with Allpresan diabetic foam cream Intensive.23
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
Budget impact
The quantity of foam cream used in an application is less than half of that of a conventional cream.24
In a small study, healthy volunteers required only 0.11g of Allpresan foam cream to cover the same area covered by 0.24g of a conventional cream24
A similar effect to a conventional cream can therefore be obtained with a substantially smaller quantity of Allpresan foam cream24
Taking this into account, a 125mL pack of Allpresan diabetic foam cream, at a cost of £5.50, should last as long as a 250g pack of a conventional cream.
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Background
Diabetes mellitus is among the most common chronic conditions in the UK and its prevalence is increasing.3,5 In 2013, there were almost 2.9 million people in the UK diagnosed with diabetes; a 53% increase from 2006.5 The majority of people with diabetes have type 2 diabetes (90%).4
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.25 Treating dry skin is a key element of preventing skin breakdown and foot ulcers in people with diabetes.1,26
A healthy skin barrier is crucial to protect against mechanical, microbial and chemical damage.9 Up to 80% of people with diabetes suffer from dry skin.6,9 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.2,9,13 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
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.2,4,8 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.4 Ulceration and amputation reduce quality of life and are associated with increased mortality.27 Foot ulcers are painful and require considerable time spent on clinic visits, hospitalisation and wound dressing changes.27 Amputations can result in long-term changes to mobility, living conditions and relationships.27
People with diabetes are also susceptible to foot infections, mainly because of neuropathy, poor circulation and reduced neutrophil function.5,28 Once the skin is broken, the infection can spread rapidly to underlying tissues, causing extensive tissue destruction and direct threat to the affected limb.8,27,28 Infection is the main reason for major amputation in neuropathic feet and a frequent cause of amputation in ischaemic and neuro-ischaemic feet.27
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. At patient at low risk of developing a diabetic foot problems 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 important of foot care.5
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The Quality and Outcome Framework (England) contains the following indicator for diabetes:29
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.7 Those with active diabetic foot disease should be referred to a multidisciplinary diabetic foot service team.7
Unmet need
Dry skin on a diabetic foot makes it vulnerable to breakdown and ulcer formation; this can be complicated by infections.2,25 Microvascular disease can cause poor blood circulation to the skin and can slow down healing of broken skin.30
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.8,10,11 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.12
Effective skin care needs to supply moisture and lipids and restore the epidermal protective function.13 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.13 Allpresan diabetic foam creams are specifically formulated to treat dry and very dry diabetic skin and can be used to cover and protect the whole foot, including between the toes.13,15,17
Foam creams
Treating dry skin with Allpresan diabetic foam creams help stabilise the epidermal barrier and improve symptoms.9 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.13 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.13 Allpresan diabetic foam creams can be applied to and will protect the entire foot, including between the toes.14
Application
Allpresan diabetic foam creams are easy to apply and can be spread evenly, including into difficult-to-reach sites such as the spaces between toes.13 They are convenient and easy for patients to use, especially those who may have mobility problems.9 The foam cream is readily absorbed, can be spread easily and is not sticky or greasy.9,15,17
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
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Dispensing
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.13
Place in therapy
Allpresan diabetic foam cream is formulated to prevent dry cracked skin and calluses on diabetic feet. Allpresan diabetic foam creams are the only products to be clinically and medically approved in the UK for use on the entire diabetic foot including between the toes.15,17 Allpresan diabetic foam cream boosts the skin’s barrier function, thus protecting against skin infections and ulceration.13–16
Allpresan diabetic foam cream forms a breathable protective coating with a specific formula that strengthens and repairs the skin barrier.15,17 Allpresan diabetic foam cream is quick to apply, non-greasy and footwear can be put on immediately after application.14
Allpresan
Indication
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. Allpresan diabetic foam cream Basic reduces roughness, counteracts pressure marks and smoothes the skin.15
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. Allpresan diabetic foam cream Intensive counteracts pressure marks and helps prevent calluses.17
Both Allpresan diabetic foam creams can be used on the whole foot, including between the toes and around wound edges. 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.15,17
Mechanism of action
Allpresan diabetic foam creams contains a unique complex of moisturising agents: pentavitin®, panthenol and urea.15,17 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.15,17 Allpresan diabetic foam cream boosts the skin’s barrier function, thus protecting against skin infections and ulceration.13–16
Pentavitin® is a moisturiser which contains naturally occurring carbohydrates, similar to those found in the stratum corneum of skin.18 Pentavitin® binds strongly to the skin and cannot be washed off easily, so moisture remains in the skin, protecting against dehydration.17,18 Pentavitin® is removed by natural skin shedding. It has a highly effective moisture-regulating capability, with long-lasting moisture-binding and moisture retention18
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 panthenol19
Urea is a keratin softener and hydrating agent used in the treatment of dry, scaling conditions.20 Urea is also used as a proteolytic agent for wound debridement.31 The hydrating properties of urea, used in concentrations up to 10%, offer clinical benefits to people with dry skin.31 It increases the moisture content of the keratinous layer of the skin, making the skin softer and more supple, as well as relieving itchiness.17 Trans-epidermal water loss, used to assess skin hydration, is reduced by urea used on both dry and healthy skin31
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Medical device
Allpresan diabetic foam creams are class IIa medical devices.21 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.22 Clinical data for a medical device means the safety and/or performance generated from the use of the device.22 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.22 There are a number of clinical trials which support the use of Allpresan diabetic foam cream.12,14,23
Clinical evidence
Study by Baker et al
A pilot study carried out in the UK examined the effects of 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. 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 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.12
For both skin dryness and skin flexibility, 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 Allpresan-3 compared with the control moisturisers, although it was not statistically significant.12
Table 1: Mean scores for each of the clinical parameters tested12
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
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 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 Allpresan-3 over their control moisturiser.12
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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: Allpresan diabetic Intensive (n=20), Allpresan diabetic Intensive Care with microsilver (n=20) and Allpresan diabetic Intensive Care with polyhexanide (n=20).14
Patients
Two-thirds (66.7%) of patients enrolled were female, and the overall mean age was 58.8 years.14
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 29.14
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.14
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 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).14
Figure 1: Mean colonisation of the interdigital spaces with gram-positive bacteria before (day 1) and after 4 weeks of application (day 29)14
Adapted from Wigger-Alberti W et al. Cosmet Med 2015;1(15):30–35.
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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).14
Table 2: Mean corneometry measurements14
Allpresan diabetic Intensive
Allpresan diabetic Intensive Care with microsilver
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.
Figure 2: Development of moisture content in the stratum corneum in relation to the application of different foam creams14
Adapted from Wigger-Alberti W et al. Cosmet Med 2015;1(15):30–35.
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Dermatological assessments
Corresponding to the increase of skin hydration, the skin dryness was markedly reduced during the 4-week 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.14
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 weeks14
Adapted from Wigger-Alberti W et al. Cosmet Med 2015;1(15):30–35.
Subjective assessments
The subjective assessments found that:14
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
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Figure 4: Subjectively-assessed skin dryness in relation to the use of different foam creams over 4 weeks14
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:14
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 Allpresan diabetic Intensive and 90% of the users of the other two groups perceived the application to be very good or good
85% 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
85% to 90% 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
Safety
No adverse effects of the foam creams occurred during the study.14
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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.14
Study by Proksch
An efficacy test and application test was carried out on 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 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.23
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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
A 125mL pack of Allpresan diabetic foam cream should last as long as a 250g pack of a conventional cream because the quantity of foam cream used in an application is less than half of that of a conventional cream.24 In a small study, healthy volunteers required only 0.11g of Allpresan diabetic foam cream to cover the same area covered by 0.24g of a conventional cream.24 A similar effect to a conventional cream can therefore be obtained with a substantially smaller quantity of Allpresan diabetic foam cream.24
Allpresan diabetic foam cream is the only urea-containing preparation specifically indicated for use in people with diabetes.32
Table 3: Basic NHS cost for preparations containing urea32,33
Product Indication Pack size
Allpresan diabetic foam cream Basic
Dry, sensitive foot skin in diabetic patients
125mL: £5.50
Allpresan diabetic foam cream Intensive
Very dry to chapped foot skin in diabetic patients
125mL: £5.50
Balneum cream Dry skin conditions 50g pump: £2.85 500g pump: £9.97
ClearZal Hard Skin Remover
Treatment and removal of callused/keratosed skin on feet
100g: £4.30
Dermatonics Once Heel Balm (25%)
Rough, dry skin and anhydrosis on soles of feet and heels
75mL: £3.60 200mL: £8.50
Flexitol 10% Urea Cream Rough, dry and anhydrotic skin 150g: £5.00 500g: £11.77
Flexitol Heel Balm (25%) Dry, cracked skin and hyperkeratosis
on soles of feet and heel
40g: £2.75 75g: £3.80 200g: £9.40 500g: £14.75
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Appendix 1: Prescribing Information
Allpresan® diabetic Foam Cream BASIC
Intended purpose 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. 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. 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 Allpresan® diabetic Foam Cream BASIC once the expiration date has passed. For external use only.
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, Propy- lene 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, 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 the reach of children. Use only in well ventilated areas.
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Allpresan® diabetic Foam Cream INTENSIVE
Intended purpose 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. 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. 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 Allpresan® diabetic Foam Cream INTENSIVE once the expiration date has passed. For external use only.
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 the reach of children. Use only in well ventilated areas.
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References
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