PREVENTDFU
Device for prophylaxis and treatment of diabetic foot ulcers for hospital and home use
| Coordinatore | OTIVIO AS
Organization address
address: GAUSTADALLEEN 21 contact info |
| Nazionalità Coordinatore | Norway [NO] |
| Totale costo | 1˙245˙221 € |
| EC contributo | 957˙783 € |
| Programma | FP7-SME
Specific Programme "Capacities": Research for the benefit of SMEs |
| Code Call | FP7-SME-2011 |
| Funding Scheme | BSG-SME |
| Anno di inizio | 2011 |
| Periodo (anno-mese-giorno) | 2011-12-01 - 2013-11-30 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
OTIVIO AS
Organization address
address: GAUSTADALLEEN 21 contact info |
NO (OSLO) | coordinator | 610˙596.85 |
| 2 |
ESPECIALIDADES MEDICO ORTOPEDICAS S.L. - EMO
Organization address
address: CALLE PEDRO ESTEBAN PERNET 21 contact info |
ES (VALENCIA) | participant | 186˙069.35 |
| 3 |
SOLANN AB
Organization address
address: UDDNASVAGEN 23 contact info |
SE (JARFALLA) | participant | 100˙881.00 |
| 4 |
EMS PHYSIO LTD
Organization address
address: DOWNSVIEW ROAD contact info |
UK (WANTAGE) | participant | 25˙642.19 |
| 5 |
NHS LANARKSHIRE
Organization address
address: FALLSIDE ROAD KIRKLANDS contact info |
UK (BOTHWELL) | participant | 16˙044.00 |
| 6 |
Nor-Tek Teknologisenter AS
Organization address
address: GAUSTADALLEEN 21 contact info |
NO (OSLO) | participant | 8˙137.61 |
| 7 |
INSTITUTO DE BIOMECANICA DE VALENCIA
Organization address
address: UNIVERSIDAD POLITECNICA DE VALENCIA EDIFICIO 9C CAMINO DE VERA S/N contact info |
ES (VALENCIA) | participant | 5˙564.00 |
| 8 |
AKERSHUS UNIVERSITETSSYKEHUS HF
Organization address
address: SYKEHUSVEIEN 25 contact info |
NO (LORENSKOG) | participant | 4˙848.00 |
| 9 |
CAMBRIDGE DESIGN PARTNERSHIP LLP
Organization address
address: CHURCH ROAD THE LONG BARN contact info |
UK (TOFT) | participant | 0.00 |
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Obiettivo del progetto (Objective)
'In PreventDFU, we propose to develop an advanced prototype for prophylaxis and treatment of diabetic foot ulcers (DFUs). This condition contributes to morbidity and loss of Quality of Life (QoL) of Diabetes Mellitus sufferers, most especially the elderly. We propose to develop a unit prototype, based on our proprietary pulsating negative pressure technology that can be used at home or nursing homes, for treatment of DFUs, and their prevention.
Over 55Mn Europeans between 20 and 79 years of age are currently suffering from diabetes; 55% above 60 years old. The incidence of diabetes is expected to grow as the population ages. Diabetes sufferers have a 12 to 25% lifetime risk of developing a DFU. Over 8Mn Europeans coudl be suffering from DFU in their lifetime. A morbid display of DFU is the lower limb amputation; 85% of the amputations in diabetes sufferers are reported after unsuccessful DFU treatment this means between 290,000 and 450,000 amputations per year, an annual cost in the order of €2 – 2.5Bn.
We believe that introducing PreventDFU technology for home and nursing home use for the primary purpose of DFU prophylaxis during sleeping hours and for the secondary purpose of assistive therapy of mild DFUs may reduce DFU incidence in the elderly and prevent a significant number of DFU-related toe, foot and leg amputations. If Prevent DFU technology can only help 5% of the DFU sufferers, this would mean substantial QoL improvement for over 400,000 Europeans and over 2 Mn sufferers worldwide, substantially reduce associated healthcare costs and give a considerable boost to the European Medical Device Manufacturing, Nursing and Assisted Living sectors. PreventDFU technology could benefit elderly pressure ulcer (PU) suffers by providing timely prophylaxis by increasing the blood flow in the legs; it has been reported that 95% of all pressure ulcers occur in the lower part of the body while 70% of those occur in persons over 65 years of age.'
Descrizione progetto (Article)
The EU-funded 'Device for prophylaxis and treatment of diabetic foot ulcers for hospital and home use' (https://sites.google.com/site/preventdfu/home (PREVENTDFU)) project is undergoing research to remedy this situation. A prophylactic device prototype called FlowOxTM will be developed to prevent or treat DFUs for use in homes or nursing homes. This device will modify existing pulsating negative pressure technology and use it to increase blood flow and prevent wound formation or stimulate healing at the ulcer site.
Scientists also worked on determining the optimal means of restoring blood flow in the lower extremities or limbs of diabetic patients using pulsating negative pressure. For this purpose, the prospective patient cohort will include diabetic or non-diabetic patients with peripheral arterial occlusive disease along with healthy subjects. Requisite ethical approvals for the study were obtained successfully and pilot experiments have already started. Study outcomes will help determine optimal treatment protocols and negative pressure settings.
PREVENTDFU scientists completed a comprehensive literature review encompassing the medical and biomechanical aspects of the device. Also, user trials were conducted to gain their perspective on DFU treatment requirements and issues with orthoses, externally applied devices used to modify the structural characteristics of the neuromuscular and skeletal system.
Based on those for ankle foot, design specifications were incorporated into the principal design and a preliminary risk analysis carried out. This resulted in the manufacture and testing of wearable leg-and-foot chamber prototypes to further optimise design. In parallel, work is ongoing to develop and optimise the other device components such as the control system, pump, valves, user interface, power supply, pressure sensor, data logging system and housing.
Ultimately, the FlowOxTM device will improve the quality of life of diabetic patients by reducing their risk for DFU-related toe, foot and leg amputations. This would also result in substantial health care savings and boost the European medical device manufacturing, nursing and assisted living sectors.