An extensive literature investigation was performed and several meetings and discussions were held with both key opinion leaders as well as with nurses at health clinics in Sweden, the UK, Germany and Denmark providing foot care for diabetic patients.
What became clear during this Phase 1 study was that the problem is even larger and more acute to deal with than we first estimated. This has strengthen us in our believe that the unmet need to reduce both Diabetic Foot Ulcers (DFU) and the very severe follow-on complications with amputations, requires a strong effort from stakeholders both on a national level as well as on a European level, with a very big opportunity worldwide, as the Diabetes is ever increasing into epidemic proportions.
In 2011 the UN held a High-Level Summit on Non-Communicable Diseases (NCDs), a major milestone in the history of global health and development. At this meeting world leaders made an unprecedented commitment to accelerate global progress on diabetes and NCDs.
As a consequence from this meeting, IDF developed a Roadmap Programme, including Guidelines for National Guidelines for Diabetes and monitoring of Diabetes related complications. In these Guidelines it clearly states that diabetes patients shall have a right to receive regularly monitoring of Diabetic NeuroPathy (DNP) as can be seen from the following excerpts from the Guideline for National Diabetes Programmes:
“8. Clinical monitoring for the early detection of diabetes complications
All people with diabetes should be monitored regularly to assess the status of their metabolic control, the possible need for treatment changes, and to detect the onset of complications at an early stage where interventions can then slow or prevent their progression. Physical and laboratory assessments should be regular and should include:
- measurement of glycated haemoglobin ( HbA1c)
- assessment of lipids
- measurement of blood pressure
- measurement of kidney function (ideally by albuminuria)
- retinal examination through dilated pupils
- foot examination (including testing sensation perception with a10g monofilament)
- weight assessment.”
http://www.idf.org/webdata/Guide-to-NDP_web.pdf(opens in new window)The conclusion we make is that for 6 of the above mentioned 7 required assessments procedures are already in place to detect the onset of complications at an early stage where interventions can then slow or prevent their progression, except for the sensation perceptions.
However, it has also absolutely been clear that Monofilament does not fulfil this requirement. Hence, Vibrosense Dynamics have an absolute unique opportunity to play a major role with high impact both for the Healthcare systems in Europe, as well as on the worldwide scene.
In a systematic review of over 30 scientific articles, involving over 8000 patients (Feng et al, 2009), indicated a very large variations in specificity, sensitivity and predictive value from as low as 36% up to 100% for monofilament. Other methods (tuning fork, and biothesiometer) shows similar ranges. This means that many patients are missed or are wrongly diagnosed with DNP.
When patients are diagnosed with DNP they should be referred to a foot clinic for specially shoe fitting (practice varies between EU countries). However, with low specificity, sensitivity and/or predictability, many patients are therefore sent first of all too late and for the wrong reasons, and patients who should be sent are missed. Hence, we want to reduce the level of False Positive and False Negative, and provide more accurate and early diagnosis of DNP to aid more intensive diabetes management of the right patients.
