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Setting the Standard of Care: An Opportunity to Impact Millions of Lives

March 28, 2017 by Arti Masturzo, MD, Executive Vice President of Clinical Innovation

I recently shared a story about a memorable patient with a complicated Wagner III Diabetic Foot Ulcer (DFU), and why I find the DFU to be my most problematic yet rewarding wound problem to treat. Today, I want to talk about how we, as a medical community, can standardize our approach to these patients.
 
There are approximately 29 million diabetic patients in the United States (U.S.), and 25 percent of those are predicted to develop a lower extremity ulcer during their lifetime. It is disappointing that despite all the advances we have made in technologies to treat DFUs, the medical community still struggles to meaningfully impact amputation or mortality rates in this patient population. Since the incidence of diabetes is expected to grow at two percent annually over the next decade, it is imperative that we make a concerted effort to educate ourselves on, and use, the most effective treatment modalities.
 
Early on in my medical training, I was taught that good medicine does not always have to be complicated or expensive.  One example is the use of the rigid total contact cast (TCC) to offload the DFU. Unfortunately, lack of reimbursement, active infection, fall risk, training, time, and noncompliance are just a few reasons why we often provide excellent wound care with the exception of the most critical thing: effective offloading.
 
Consider some compelling facts:
  • DFU healing is unlikely in the absence of adequate offloading despite management of vascular disease, infection, wound bed preparation, and moist topical management.
  • Current peer reviewed evidence demonstrates healing rates of 80-90% within six weeks when TCC is utilized to offload the DFU.
  • The success of healing with TCC is reduced in practice to 25%.
 
One of the first patients treated in our wound center was a Type 2 diabetic patient in his 60s who had a non-healing Wagner II ulcer for almost two years. He was meticulous about his medical care and surprisingly had no complications from the ulcer during that time. One of our panel physicians, a vascular surgeon, had been treating him in his office with various topical dressings with no success and referred him to the wound center for care. Having never applied a TCC, he requested that we see the patient together.

 
Week-1-200x44.png    
   
Week-1-(2).jpg The patient had a fifth metatarsal plantar foot ulcer with callus and a clean but stalled wound base.  After confirming adequate circulation, we excisionally debrided the ulcer including surrounding callus. We ordered blood work and imaging to assess his diabetes, nutrition status, and to rule out osteomyelitis. A total contact cast was applied and the patient was seen two days later to reapply the TCC and review labs.
     
     
     
Week-3-200x44.png    
The cast was changed weekly thereafter and by week three the ulcer had fully epithelialized using a simple combination of TCC and debridement. We reapplied the cast while awaiting custom molded orthotics to prevent recidivism since newly healed tissue is so fragile. Upon discharge from the Wound Care Center, the care team transitioned the patient to a community podiatrist for ongoing preventive care. After that, our vascular surgeon not only became a champion for TCC offloading, he also became the biggest advocate for our Center!      Week-3-fully epithelialized

 

The evidence for offloading the DFU with casting methods is well-accepted by the wound care community, yet external factors have reduced use by clinicians to only 25 percent of DFUs. If utilization of TCC to offload the ambulatory DFU patient is scientifically validated, should it not be considered first line therapy?
 
By raising awareness of the morbidity and mortality associated with DFUs, the wound care community has an opportunity to impact millions of lives, but before we can do that, we must first standardize our practice based on the best available evidence. It is going to fall on us as wound clinicians to set the standard for offloading in our wound care centers. I do not consider offloading the DFU with TCC an advanced modality; I would contend it is the standard of care and therefore first line therapy to be used early in treatment plan.
 

Cumulative probability of healing: Wagner Grade I and II with casting Healogics conducted a retrospective observational analysis to test whether there is an association between the application of a total contact cast and healing among Wagner Grade I and II DFUs in Healogics Wound Care Centers. The results indicate that among these ulcers there appears to be a directional association such that wounds that are casted are more likely to heal and those that are casted earlier have a reduction in the days to heal.

 
Sources
  • Shah (2012) ‘Clinical and Economic Benefits of Healing Diabetic Foot Ulcers with a Rigid Total Contact Cast’ Wounds Vol. 24 Issue 6 pg. 152–159 Link: http://www.woundsresearch.com/article/clinical-and-economic-benefits-healing-diabetic-foot-ulcers-rigid-total-contact-cast
  • Fife (2010) ‘Why is it so hard to do the right thing in wound care?’ Wound Repair and Regeneration Vol 18 Issue 2 pg. 154–158 Link: http://onlinelibrary.wiley.com/doi/10.1111/j.1524-475X.2010.00571.x/abstract
  • June 2014 American Diabetes Association Fact Sheet. 2013 US Census Bureau. 2013 United Health Group. L.E.K. Consulting 2014 Market Analysis “Market Sizing and Assessment of Outsourced Outpatient Wound Care”
  • Sen, Chandan K., Gayle M. Gordillo, Sashwati Roy, Robert Kirsner, and Lynn Lambert. "Human Skin      Wounds: A Major and Snowballing Threat to Public Health and the Economy." Wound Repair Regen.  17, no. 6 (2009): 763-71.