Thank you for providing the opportunity to present our proposal for a Diabetic Foot Ulcer Offloading Clinic (DFUOC). This presentation will highlight the design of the proposed clinic including the “why, who, what, how, when, and how much” of protecting the diabetic foot.
In Canada, the prevalence of diabetes mellitus is increasing currently about 6% per year with a predicted 2.8 million people diagnosed by 2012 according to the National Diabetes Surveillance System (NDSS , 2009). A report from the Canadian Diabetes Association, An Economic Tsunami: The Cost of Diabetes in Canada ( 2009) suggests that there will be 3.7 million people in Canada with diabetes by 2020 or 9.9% of the population compared to 4.2 % of the population in 2000. 10 – 15 % of people with diabetes will develop DFU (Ministry of Health and Long Term Care - MoHLTC, 2005) – potentially 280,000 - 420,000 people with ulcers 14-20% of people with DFU will have a major lower extremity amputation (LEA) (Orstead et al., 2006) In fact, a DFU is the precursor of 85% of all LEA (Orstead et al., 2006) The costs related to a LEA for treatment in the first year is approximately $36,666.00 (Goeree et al., 2009) and DFU’s cost the Canadian health care system more than 150 million dollars annually (Canadian Association of Wound Care - CAWC, 2011). The CDA suggests that the total cost of diabetes will increase by 180% between 2000 and 2020.
To address the needs of the patient who has a (DFU), the cause of the wound must be determined. The CAWC (2006) suggests that “Pressure is a factor in 90% of diabetic plantar ulcers, and the pressure must be modified or removed”. The best practice guidelines (BPG) for the treatment of DFU state that the pressure must be removed from the ulcer to allow for healing to occur (Orstead et al., 2006 and RNAO, 2005). The available evidence to support offloading to allow for wound healing is strong (Bus et al., 2008, Cavanaugh et al., 2011, Orsted et al., 2006, Wu et al., 2008).
Some of the research regarding offloading includes: Cavanaugh and Bus (2010) found that when used appropriately, offloading does reduce the length of time to heal DFU. In a Cochrane Review, Spencer (2008) found evidence for offloading DFU to promote healing but cautioned that the quality of the studies is not optimal and more research is required. Bus et al. (2008) found evidence for non-removable offloading devices to heal DFU in their systematic review. However, they also recommend more research is required.
Despite evidence supporting offloading, Wu et al. (2008) found among 895 centres in the US that treated DFU: (read slide) This is interesting as the treatments with better evidence are used less than the treatments with poor evidence for offloading.
Wu et al. (2008) were not the only ones to show that EBP is not always “practiced” as Cavanaugh and Bus’ (2011, p. 253S) research agrees. Our team at CODG has conducted a small pilot needs survey with a group of practicing wound care professionals. Preliminary findings show: (click)
71.4% of the respondents (click) (7 of 14 to date) are implementing some type of offloading technique. (Click) 50% of the same respondents indicate that the treatment is not working due to the lack of appropriate or timely offloading. The respondents also indicate that “quicker triage” is required and “having onsite expertise available” would improve treatment outcomes. (click) The offloading is not provided soon enough or in the appropriate manner. Again, of note: the survey was sent to professionals who are currently providing treatment for patients with DFU.
It is important to understand the significance of pressure with respect to people with diabetic feet. There are three factors that alter the impact of pressure on the diabetic foot. (click) Diabetes will cause a loss of protective sensation (LOPS). The person will continue to walk or stand on the feet even if there is something that should normally cause pain. (click) Diabetes also affects the motor nerves which result in foot deformities such as claw toes. The metatarsal areas of the feet become areas of high pressure. (click) (click) Autonomic neuropathy can lead to a series of events that result in a Charcot Foot where the bones of the foot and ankle are affected leading to a destruction of the boney structure and possible severe deformity of the foot. Ultimately the person with diabetes can have a foot with physical deformities which cause excess pressure and no ability to sense destructive forces.
The CAWC (2006) uses the mnemonic “VIP” to help remember the three factors that can be influenced to affect healing of the plantar DFU. As a significant factor in the promotion of healing DFU, redistribution of pressure is the basis for the working hypothesis and the focus of the treatment protocol for the DFUOC.
To address the issue of pressure for people with DFU, the DFUOC is proposed. The basis of this proposal is: If a formal DFUOC is established for delivery of pressure reduction treatments to neuropathic DFU, and if there are clear and consistent referral protocols, then there will be a reduction in ulcer healing time and a reduction in LEA.
Using the existing resources of staff, funding and physical locations, the program proposes to expand the current patient care to include diabetic offloading using the BPG of the RNAO and CAWC. The CO’s are experienced in the treatment of patients using externally applied devices to support, align, correct and protect body parts. Our specialty is to modify force to minimize injury or deforming forces to the patient. The RTO’s are experienced in the fabrication of all offloading orthoses to the specific criteria as set out by the CO. All manufacturing occurs in the head office in Mississauga to provide our staff with total quality control. The basis of treatment for patients is the implementation of sound orthotic principles to protect the neuropathic foot. BPG by the RNAO and CAWC provide evidence for treatment algorithms. CODG currently has accessible private clinics in Mississauga, Guelph, Hamilton, Oshawa and one inside of The Credit Valley Hospital in Mississauga. Our CO’s are available for house calls to hospitals and nursing homes. Procedures and protocols are well established after 15 years of practice. As a company with recognized health care professionals and an established record, we are authorizers for funding with the MoHLTC Assistive Devices Program (ADP), DVA, NIHB, ODSP and other funding agencies. The services provided are prescribed by a physician and the patient and/or appropriate funding agency will pay for the treatment. There is no cost to the institution. The clinic model is designed to be a stand alone clinic, however we have the ability to integrate the system into existing multi-disciplinary wound clinics or travel to new locations.
The DFUOC is designed to treat people who have plantar DFU. The treatment protocol includes a thorough assessment including a past medical history, physical examination and gait analysis (if possible). Once the assessment is complete, a treatment plan is designed and if the patient chooses to proceed, the plan is implemented. Follow-up and re-assessment is essential to success. Each patient is educated with respect to findings of the assessment and the implications. The treatment plan is explained and discussed. Reasoning for the treatment choice is addressed and supported. All questions are answered. F/U appointments are scheduled based on the needs of the patient; usually at 2 week increments until healing occurs.
Each patient is assessed and a treatment plan is designed based on the individual needs. Some of the interventions include orthopaedic shoes, FO, cast boots, RCW, CROW and TCC. As each patient is an individual, the treatment plan and interventions are as well.
Wound offloading – redistribution of plantar pressure based on the evidence to support the concept of improved healing with the removal of pressure. Patient Education – Using the Health Belief Model (HBM) (Hodges and Videto, 2011) as a basis, providing education as a strategy to the patient to address the beliefs regarding the complications of diabetes will encourage the patient to be more engaged and adherent to the treatment plan. According to the HBM, constant education and reminders regarding potential outcomes of a DFU including infection, amputation and death affect the perception of susceptibility and severity creates a sense of fear or a perceived threat. With further education and guidance, the benefits to treatment are reinforced. The patient will then be able to more effectively evaluate the situation and respond accordingly. The ultimate goal is to engage the patient as a team member to improve adherence to the treatment plan thus improving outcomes.
Length of time to heal (weeks), healing rates (10% healing every two weeks), amputation (absolute #) and death rates data of the clinic participants will be collected and used for outcome measures to compare to existing statistics. QoL measures will be obtained at initial clinic intake and upon discharge.
Ongoing data collection at the institution level can be compared between clinic participants and non-clinic participants to determine efficacy of clinic treatment with respect to the effect on LOS and amputation and death rates. The reduction in hospitalizations, wound care, amputations and other medical complications will reduce the cost of treatment of people with DFU.
To summarize, CODG will provide (click) evidence based care with (click) experienced practitioners based in a (click) established practice, addressing a (click) growing need. Using (click) existing funding CODG will provide complete offloading for the patients of your community at no cost to the institution ( insert appropriate agency name here ). Reducing time to heal, reducing amputations will reduce hospitalizations, length of stay in hospital and deaths while improving quality of life for patients.
Reducing time to heal, reducing amputations, and the corresponding reduction in hospitalizations, length of stay in hospital and deaths will result in (click) cost savings to your institution.
85% of alllower extremityamputationsare preceded bya diabetic footulcer (DFU) (Orstead et al., 2006) http://www.customorthotic.ca
“Pressure is a factor in 90% of diabetic plantar ulcers, and the pressure must be modified or removed” (CAWC, 2006) http://www.customorthotic.ca
Evidence Based Diabetic Ulcer Care• Uncomplicated plantar ulcers can be healed in 6-8 weeks with pressure offloading – Cavanaugh and Bus (2010)• There is evidence that offloading with a Total Contact Cast (TCC) is effective at healing ulcers – Spencer (2008)• There is evidence that non-removable offloading treatments help healing – Bus et al. (2008) http://www.customorthotic.ca
Evidence Based Diabetic Ulcer Care895 centres - 1.7% used the gold standard TCC - 15.2% used a removable cast walker (RCW) - 2.6% used other modalities (therapeutic shoes) - 41.2% used shoe modifications - 12.3% restricted weight bearing (Wu et al., 2008) http://www.customorthotic.ca
Evidence BasedDiabetic Ulcer Care “there is a gap between evidence-based guidelines and current practice…” (Cavanaugh and Bus, 2011, p.253S) http://www.customorthotic.ca
Evidence Based Diabetic Ulcer CareInformal needs survey – 71.4% are using offloading – 50% state that the treatment is effective “I think it is effective when used properly” Survey respondent http://www.customorthotic.ca
Pressure• Sensory Neuropathy loss of sensation• Motor neuropathy deformity• Autonomic neuropathy deformity http://www.customorthotic.ca
Three Factors for Best PracticeTreatment of Diabetic Foot Ulcers • Vascular • Infection • Pressure http://www.customorthotic.ca
Improving outcomes for People with Diabetic Foot Ulcers• Formal DFU offloading clinic• Clear and consistent referral pathway• Reduction of pressure to diabetic feet• Reduction in ulcer healing times• Reduction in lower extremity amputations• Reduction in cost of DFU http://www.customorthotic.ca
Inputs• Staff – 5 Certified Orthotists (C.O.c) – 2 Registered Technicians (R.T.O.c) – 2 Administration• Best Practice Guidelines: RNAO, CAWC• Clinics – 5 private in GTA – 1 in Hospital• Funding – ADP, DVA, NIHB, ODSP, SI, TPI http://www.customorthotic.ca
Outcomes• Reduction in ulcer healing time• Reduction in amputations• Improved quality of life for patient http://www.customorthotic.ca
Impact• Reduction in hospitalizations and length of stay• Reduction in cost of wound care• Reduction in amputations• Reduction in deaths http://www.customorthotic.ca
Diabetic Foot Ulcer Offloading Clinic• Evidence based care• Experienced practitioners• Established practice• “Economic Tsunami”• Existing funding http://www.customorthotic.ca
Diabetic Foot Ulcer Offloading Clinic• Reduction in ulcer healing time• Reduction in amputations• Reduction in deathsResults in: Cost savings to hospitals http://www.customorthotic.ca
Diabetic Foot Ulcer Offloading ClinicAnd: Improved Quality of Life for our Patients http://www.customorthotic.ca
ReferencesBus, S.A., Valk, G.D., van Deursen, R.W., Armstrong, D.G., Caravaggi, C., Hlavecek, P., Bakker, K., Cavanaugh, P., R. (2008). The effectiveness of footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in diabetes: A systematic review. Diabetes Metabolism Research and Reviews. Vol. 24(Suppl 1):S162-S180.Canadian Association of Wound Care Website (n.d.). Statistics: Diabetic Foot Ulcers. Retrieved from: http://cawc.net/index.php/public/facts-stats-and- tools/statistics/ Accessed May 25, 2011.Canadian Diabetes Association (2009). An economic tsunami, the cost of diabetes in Canada. Toronto, Canada.Cavanaugh, P.R., Bus, S.A. (2011). Offloading the diabetic foot for ulcer prevention and healing. Plastic and Reconstructive Surgery. January Supplement. Volume 127, Number 1S.Goeree, R., Lim, M.E., Hopkins, R., Blackhouse, G., Tarride, J., Xie, F., O’Reilly, D. (2009). Prevalence, Total and Excess Costs of Diabetes and Related Complication in Ontario, Canada. Canadian Journal of Diabetes. 33(1):33-45.Hodges, B.C., Videto, D.M. (2011). Assessment and Planning in Health Programs (2nd ed.). Sudbury, MA: Jones and Bartlett Learning, LLC.Ministry of Health and Long Term Care (2005). Hyperbaric Oxygen Therapy for Non-Healing Ulcers in Diabetes Mellitus. Hyperbaric Oxygen Therapy - Ontario Health Technology Assessment Series 2005; Vol. 5, No. 11. Retrieved from: http://www.health.gov.on.ca/english/providers/program/mas/tech/reviews/pdf/rev_hypox_081105.pdf.National Diabetes Surveillance System (NDSS): Diabetes in Canada 2009. (2009). Report from the national diabetes surveillance system: Diabetes in Canada, 2009 No. HP32-2/1-2009) http://www.phac-aspc.gc.ca/publicat/2009/ndssdic-snsddac-09/2-2-eng.php. Her Majesty the Queen in Right of Canada.Orsted, H.L., Searles, G., Trowell H., Shapera, L., Miller, P., Rahman, J. (2006). Best Practice Recommendations for the Prevention, Diagnosis and Treatment of Diabetic Foot Ulcers: Update 2006. Wound Care Canada. Vol. 4, No. 1. 57-71.Pope, M. Medical Doctor, Vascular Surgeon. The Credit Valley Hospital. Mississauga, Ontario.Registered Nurses’ Association of Ontario (RNAO) (2005). Assessment and Management of Foot Ulcers for People with Diabetes. Toronto, Canada: Registered Nurses’ Association of Ontario.Spencer, S. (2008). Pressure relieving interventions for preventing and treating diabetic foot ulcers (Review). The Cochrane Library. Issue 3.Witkowski, K. Registered Nurse. Skin and Wound Specialist. Trillium Health Centre. Mississauga, Ontario.Wu, S.C., Jensen, J.L., Weber, A.K., Robinson, D. E., Armstrong, D.G. (2008). Use of Pressure offloading devices in diabetic foot ulcers; Do we practice what we preach? Diabetes Care Volume 31, Number 11.
The Wound Care Team needs our Certified Orthotists.Patients need access to care.Linda Laakso B.Sc.C.O(c)Custom Orthotic Design Group Ltd.This is part of a presentation originally completed by the author as a project for RS709 McMaster U.http://www.customorthotic.ca