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Foot Foam Cream Clinical Update -‐ Diabetic Foot Management Background Every three minutes someone in the UK learns that they have diabetes1. The number of people diagnosed with diabetes in the UK has increased to more than 3.2 million2, and estimates suggest a further 850,000 people in the UK have diabetes but are either unaware, or have no confirmed diagnosis3. 80% suffer with some form of diabetic skin problem as a consequence of high blood sugar levels and the skin problems are most visible on the legs and feet. Typical symptoms include extreme dryness, calluses, pressure ulcers & cracks. Dry & cracked skin is more vulnerable to foot fungus and bacteria and the tiniest wound is a real risk for infection. Intensive daily care to the feet must therefore include an appropriate skin care regime to replenish the skin’s moisture and fat content, as well as create a protective layer against the outside environment4. Any area that is not protected on the feet, including between the toes, poses a real risk of infection as bacteria can enter through the skin more easily.4 As creams can cause accumulation of moisture and maceration, the advice given to diabetics is not to use them between the toes, as this additional moisture will make the skin even more susceptible to bacterial growth and increase the risk of infection11. This is where Allpresan® Diabetic Foam Creams differ. What is Allpresan® Diabetic Foot Foam Cream? Allpresan® INTENSIVE 10% urea (35ml & 125ml) is a preventive treatment for very dry to cracked skin at risk of infection & ulceration in patients with diabetes mellitus. It is recommended for use on the whole foot, including between the toes and around wound edges.5 Allpresan® BASIC 5% Urea (35ml & 125ml) is a preventive treatment for dry, sensitive and parchment-‐like foot skin in patients with diabetes mellitus. It is recommended for use on the whole foot, including between the toes and around wound edges.5 How does Allpresan® Diabetic work & why is it different? “More than just a moisturiser” Allpresan® Foam Creams are clinically formulated to treat and prevent dry skin on diabetic feet, reduce cracks and the build up of hard skin & calluses, counteract pressure marks and protect against infection and ulceration. Patented Technology This is achieved because of the Allpresan® patented actively breathable formula and the unique moisturising complex of Urea, Pentavitin® and Panthenol. 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, such as bacteria. Moisturising Complex Urea is a scientifically recognised moisturiser and makes the skin supple while strengthening its protective barrier. Urea softens and makes the skin smooth, stabilises the barrier function, improves the regenerative ability of the epidermal barrier, relieves itching, increases skin exfoliation and prevents thickening of the skin6,16 Pentavitin® is a highly-‐potent moisturiser and acts as a “moisture magnet” attracting water into the skin and protects against water loss. Panthenol is a moisturiser that promotes the regeneration of the skin barrier. 8,9 This complex means that Allpresan® diabetic foam creams are particularly effective moisturisers, providing optimum hydration to the skin.9 The water content of the foam cream evaporates more quickly from the skin surface than that of conventional creams and the product converts faster into a lipophilic form, resulting in a higher concentration of the effective substances (i.e. Urea, Pentavitin, Panthenol) and better absorption through the skin13. Even after 30 minutes when the water content of the foam cream is lost to a great extent by evaporation, individual foam bubbles can be seen under the microscope. This implies no occluding layer is formed and trans epidermal water exchange between epidermis and the external environment is maintained.13 How does Allpresan® protect against infection & ulceration? The horny layer of the skin protects against the entry of damaging substances, as for example, fungal pathogens and/or bacteria. If the fat and moisture content of the horny layer decreases, as in the case of dry skin, the horny layer loses its protective function. That is why it is so important to take care that the skin barrier stays intact especially on the feet of diabetics. An intact skin with an intact horny layer protects against infections and ulceration. If there is dry skin, cracks or fissures between the toes, which are not being treated, the risk of infection is a real danger.15,16. As Allpresan® can be used between the toes, it is unique in protecting against the real risk of infection in this area. Clinical Proof The moisture levels were seen to increase by over 50% in just 7 days & continued to increase over 28 days11, increasing patients willingness to continue with the treatment and increasing compliance. 11 Corneometry Measurements [a.u] Absolute values: Day 1 (23.0), Day 7 (34.7), Day 28 (37.4) Moisture continues to increase for up to 8 hours Comparison of the moisture values with and without application in the morning of foam cream containing 10% urea on 33 patients with insulin-‐dependent diabetes and early-‐stage diabetic foot syndrome over 8 hours.12 Significant increase in skin moisture after just 4 hours. Moisture levels last up to 8 hours after only one application compared to untreated skin. The skin stays moist and protected from the damage, which could lead to possible infection compared to untreated skin. 12 W. Wigger-‐Alberti -‐ Summary of Absolute Values and Change from Baseline Gram Positive Bacterial Counts [Log10] The use of Allpresan® does not lead to an increased microbial growth in the interdigital spaces10. No clinically significant increase in bacterial counts were seen over the period11. Allpresan® Diabetic Foot Cream can be used between the toes, unlike creams10 Patient Assessment Results -‐ W. Wigger-‐Alberti, M.D Single-‐centre, randomised, double-‐blind trial compared to baseline (n=20) Patients were asked to rate the questions in Graph 1. Results show overall patient assessment as a percentage of results recorded (very good or good) compared to baseline. Graph 1 Patient Assessment Results -‐ W. Wigger-‐Alberti, M.D Single-‐centre, randomised, double-‐blind trial compared to baseline (n=20) Patients were asked to rate the questions highlighted in Graph 2. Results show overall patient assessment as a percentage of results recorded (very good or good) compared to baseline Overall, Allpresan® foam creams are preferred by 80% of patients over conventional creams and ointments. 90% agreed it would increase their willingness to use daily and 100% would recommend using Allpresan® to other diabetics11 Graph 2
90% of patients rated the improvement in their skin condition as very good or good. Ø Allpresan® foam creams spread very effectively and evenly compared to conventional creams, and do not occlude the skin or leave any residue, ensuring full even skin coverage and making them ideal for use between the toes. Conventional creams are not recommended to be used between the toes as they are not evenly spread and cream residues can build up so that the skin becomes too moist underneath which can lead to bacterial infections.11,13 Ø Allpresan® foam creams absorb rapidly and completely without leaving behind an unpleasant greasy film and the two-‐dimensional mesh allows the skin to breathe. Tights and socks, even compression stockings, can be worn instantly. The daily routine is not restricted.
Ø Allpresan® foam creams have a 10-‐fold increase in volume and last up to twice as long as conventional creams and ointments, which in turn create much lower daily treatment costs
. 11,13
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How to use Allpresan® Foam Creams (35ml & 125ml) Apply an amount about the size of a hazelnut or walnut to the affected areas of the feet in the morning and evening, including between the toes and around wound edges. Shake well before each use, and hold the container upright when applying. Allpresan® Intensive and Basic foam creams are recommended to be used as shown below. References. 1. This figure was worked out using the diagnosed figure from the 2009 Quality and outcomes framework with figures from the 2010 Quality and outcomes framework: Quality and Outcomes Framework (QOF) 2009. Accessed September 2014 2. New figures, QOF Diabetes Prevalence 2013 (February 2014)-‐ http://www.diabetes.org.uk/About_us/News/Number-‐of-‐people-‐diagnosed-‐with-‐diabetes-‐reaches-‐32-‐million/. Accessed 8 Sept 2014 3. http://bit.ly/prevalence2010. State of the Nation 2012. Accessed Sept 8 2014. 4. Dr Rainer Thiede, Dr Martin Lederle, Prof Rolf Daniels: Skin Care and Diabetes, Diabetes and the Skin 2011 2nd edition:35-‐39 5. Clinical Evaluation Report December 2010 (5,6 & 9) 6. Dr.Eleanor Fohles, Viersen – Dermotopics 11 (2011) 62-‐64 Foam Creams 7. Young M, Townson M, Hicks G (2014). A photographic scale to aid appropriate foot skin care for people with diabetes. The Diabetic Foot Journal 17: 70–3 8. Pentavitin Data Sheet 9. Clinical Evaluation December 2010 (5,6 & 9) 10. Skin care in between is recommended. Der Fuss 7/8 2000 11. Clinical Investigation Report,2011 Wigger-‐Alberti (2010) 12. Dr. Reimar Rudolph , Norden 13. Skin and Foot – Medical Skin Care of Patients with Diabetic Foot Syndrome. Thieme Praxis Report 2013;5(11) 14. Prof. Dr Med. H Tronnier, Prof. Dr. Ulrike Heinrich – Definition of the Quantity applied of both products – Unpublished study 2009 15. Podologie Nr.1 March 2005 16. Prof. Erhardt Proksch, University Skin Clinic, Kiel – Urea not a harmful substance, Der Fuss, 02/2004 14-‐16 ALL-‐1001 Neubourg Pharma (UK) Ltd info@neubourgpharma.com www.allpresan.uk.com