Turning Evidence Into Practice: A Guide To Treating Chronic Wounds In The Diabetic Foot
In reading many of the recent articles in podiatry publications, we will need to expand our vocabularies to include various new phrases. These phrases will include pay for performance, evidence-based medicine or evidence based treatment plans, and evidence-based treatment guidelines. Electronic medical records (EMR) and electronic health records (EHR) will be linked to evidence-based guidelines at the point of care. These changes are also reverberating within the primary care settings and in other selected specialties.
What can this mean for any practitioner let alone the solo practitioner who may not have the financial and/or infrastructure resources that large multispecialty clinics often do?
Practitioners will need to answer other questions as well. Why should they implement an EMR/EHR? How does the podiatrist translate evidence that may or may not yet exist for therapies and procedures one performs in practice? What are the financial and human resource impacts to his or her practice? Should the practitioner initiate EMR/EHR in his or her practice now or wait for governmental agencies to provide their “free computer software”?
One of the first areas that CMS and some insurance plans have targeted for these quality improvement projects is in the arena of diabetes management and wound care as it relates to people with diabetes. Podiatry Today has recently published articles regarding these issues (see “Pay For Performance: How Will It Impact Diabetic Foot Care?,” page 20, June issue) and the American Podiatric Medical Association (APMA) has recently provided the membership information on the quality measures that podiatrists most likely can report to the Center for Medicare and Medicaid Services (CMS).
Given these developments, I started thinking about how I could position my practice to be more proactive as a leader in the realm of treating lower extremity wounds in people with diabetes. I started by gathering guidelines and protocols that have been published in the treatment of diabetic foot ulcers, including guidelines from the American College of Foot and Ankle Surgeons (ACFAS) and the International Diabetes Federation (IDF).
Understanding The Impact Of Diabetes And Lower Extremity Complications
We have all seen the facts and figures surrounding diabetes and the lower extremity complications associated with the disease. Of the estimated 22 million Americans with diabetes, 15 to 20 percent will develop a foot ulcer during their lifetime. Foot complications have become one of the leading causes of hospitalization for patients with diabetes and the patients hospitalized with a diabetic foot ulcer (DFU) can expect a 59 percent longer length of stay than hospitalized diabetic patients without a foot ulcer.1,2
Despite all the efforts to prevent amputation in the last 10 years, the incidence of lower extremity amputation in people with diabetes continues to rise. Fourteen to 20 percent of patients with a DFU will require a lower extremity amputation (LEA). What concerns me the most is the fact that once a person has one amputation, he or she will require another amputation within three to five years, Often, a higher level of amputation will be required. Revision to a higher level occurs 15 percent of the time. In these cases, researchers have noted operative mortality at 7 percent. Indeed, 50 percent of patients with diabetes who undergo a second amputation at a high level are likely to become bedridden or die in two years.3-5
Given the fact there is only a 50 percent chance that people with diabetes who undergo a second amputation will be alive in three years, preventing amputations is more imperative than ever. The direct costs for an ulcer and amputation by level are as follows:4
Foot ulcer $16,580
Transmetatarsal amputation $25,241
Transtibial amputation $31,436
Transfemoral amputation $32,214
These numbers do not take into account the cost of disability to the families whose loved one had to undergo the emotionally and financially devastating procedure of amputation.
Have We Become Complacent With Chronic Wounds?
There is an increasingly urgent need for highly efficacious, cost-effective treatments for diabetic foot ulcers given the diabetes epidemic that is occurring in the United States.
Lawrence Harkless, DPM, one of podiatry’s pioneers in the diabetic foot arena, has noted that an ulceration usually precedes an amputation in patients with diabetes. What available modalities do we have at our disposal to treat the ulcer before the patient requires an amputation?
When we perform surgery, we expect our incisions to heal in two to three weeks and we would normally remove sutures at this time. Then why do we commonly accept a wound, albeit one not caused by our hands, which has not healed in this almost standard timeframe? What treatments can we use when we see a wound that has not healed or made sufficient progress in two months?
Chronic wounds involve hyperactive tissues that do not heal due to a perpetual inflammatory process. In these situations, pro-inflammatory cytokines, proteases and cellular adhesion molecules overwhelm the wound bed.
Insights On Vascular Testing And Appropriate Referrals
Obviously, we work up these patients by obtaining a thorough medical history and doing a physical examination that is directed by the medical history. The American Diabetes Association and the Peripheral Arterial Disease (PAD) Coalition have published consensus statements, based on the evidence available in the current literature, which support the measurement of ankle-brachial indexes (ABI) and toe pressures for people with nonhealing wounds, especially people with diabetes, in order to assess for PAD.
One should also pursue noninvasive vascular testing for these patients. One may use a Doppler unit as long as the Doppler is bi-directional with a printout to record waveforms. This is acceptable under most insurance plan coverage policies. Physicians can also utilize the new systems available for obtaining pulse volume recordings (PVR). I use the Smart Dop 45 (Koven), which has a computer software model that I can link to my EHR (Medinotes).
If the results indicate there is vascular disease, I will refer the patient to a vascular surgeon or interventionalist colleague for further vascular assessment and possible endovascular intervention (such as the SilverHawk procedure by FoxHollow). Currently, there is four years’ worth of clinical documentation on the SilverHawk procedure.6
While this type of intervention may not ensure the affected blood vessel will remain open for the life of the patient, it may facilitate patency of the vessel long enough to heal the wound and salvage the limb. This procedure does not necessarily burn any bridges.
Should another SilverHawk procedure or an open bypass type procedure be required in the future, the surgeon can still accomplish the subsequent procedure.
What About Skin Substitutes?
Once the patient has restored blood flow in this area, I can proceed with further assessment for any infections (using appropriate oral antibiotics if necessary) and perform bone and soft tissue debridement as needed.
If no bone resection is necessary and one can move on to promoting wound healing, I consider the use of skin substitutes and there are many choices in this arena. However, only two products have the highest level of evidence via pivotal clinical trial data. Apligraf (Organogenesis) is a living human-derived, bilayered cell delivery system of keratinocytes and fibroblasts. These cells deliver the growth factors, allow the patient’s own cells to promote wound healing and allow the wound to emerge from the chronic inflammatory process it has been “stuck in.”
Apligraf is the only FDA-approved product for use with both venous and diabetic ulcers. There is Level 1 evidence to support efficacy in these instances. Apligraf provides both keratinocytes and fibroblasts as a bilayered cell delivery system. It provides the full range of growth factors and cytokines that the chronic wound may require in order to heal.
While Dermagraft (Advanced BioHealing) also has research behind it, the modality only recently came back on the market. Dermagraft provides fibroblasts alone, which may not be capable of producing all the cytokines and growth factors that our bodies are capable of producing. It is approved for diabetic foot ulcers only.
This is similar to Regranex in that this is a gel containing only one growth factor, platelet derived growth factor (PDGF) beta. It does have Level 1 evidence as randomized clinical trials also had to be performed prior to approval by the FDA for diabetic foot ulcers.
As for the other “tissue substitutes,” Oasis (Healthpoint), Integra (Integra Life Sciences) and Graft Jacket (Wright Medical) are all nonliving acellular wound products and are most often classified as wound coverings. When I see the word acellular, I start to wonder what these products provide other than a covering that can prevent the wound from becoming colonized or infected. However, these products cannot deliver the growth factors and cells that are either missing or lacking activity in a patient with diabetes or with edema due to venous reflux/congestion.
In regard to Orcel (Ortec International), a living bilayered cellular matrix, while it has an indication for donor site wounds in burn patients, the modality does not have FDA indications for diabetic or venous stasis ulcers.
Based on this information and my goal of putting into practice evidence-based medical decision making and treatment protocols, Apligraf is the clear cut answer to my question of how to close the nonhealing wound in the shortest amount of time.
Does The Evidence Support Other Commonly Used Wound Care Modalities?
Offloading is also an important factor. Again, the evidence suggests that either total contact casting or the instant total contact cast, as described by Armstrong and Lavery, is my answer for patients who want to ambulate to some degree.7 Otherwise, the use of a wheelchair and complete non-weightbearing is an option but one that is often not the best for most of my patients who continue to lead active lives.
I have not discussed dressings for the wound. There is no significant evidence available from manufacturers or in the literature on wound dressings and their efficacy. Moist wound healing, as researchers showed during the Regranex (Johnson and Johnson) clinical trials, provides the optimum environment for wound healing.
Platelet concentrates have been a hot topic again in the wound healing arena. As of this date, concentrates are not FDA approved for wound healing indications. There is at least one ongoing clinical trial looking into this technology. In the past, there was not enough evidence that platelet concentrates improved wound healing. Accordingly, the technology is not covered as it is currently seen as experimental by most insurance plans.
There is evidence to support the use of negative pressure wound therapy (NPWT), which is indicated for deeper and larger wounds as well as to help control edema. It is not intended to take the wound from a large defect to complete epithelialization. I often use VAC therapy (KCI) for a few days to a few weeks to fill in areas of large defect.
Emphasizing The Value Of Electronic Health Records
In regard to the treatments I discussed above, they are documented within the EHR. Accordingly, I can query the database to look at the outcomes of my patients based on the treatment, diagnosis, rate of wound healing and time to healing. I also use my EHR to follow my patient once the wound is healed by using Practice Health Maintenance (PHM), a component of the EHR.
I also take digital photographs of all wounds I treat before and after debridement. I then use computer software (PictZar) to document the size (length, width, area and circumference of the wound) and depth of the wound. The software allows me to measure the necrotic and or fibrotic tissue present in the wound, and follow the progression of the wound. One may also use the software to show improvement over time in either graphical or table formats. This software also is linked to the EHR, which allows one to have a complete medical record in one place. Using this electronic method of measuring improves the accuracy of measurements as well.
Once the wound is healed, and if indicated, I may fabricate custom orthotics to offload bony prominences or dispense extra depth shoes and insoles. I may also do follow-up ABI and toe pressure measurements after the vascular intervention depending on my relationship with the interventionalist.
Physicians can accomplish this via the PHM module, in which one can set parameters to recall patients for follow-up examinations. I can also send reminders to patients about recovering the covers on their orthotics, replacing the insoles in their extra depth shoes or getting a new pair of shoes if indicated by excessive wear and tear the following year. I also use this module to track patients for their yearly comprehensive diabetic foot exams, again sending reminders to patients who have not had a yearly foot exam. The PHM module also facilitates discussions about smoking cessation, weight loss measures and exercise activities, all preventive care issues.
This is what I call proactive medical decision making. I may be able to use the data on healing rates to negotiate with insurance plans in the future as well as to show quality care based on the information contained in the EHR. I can also point to patient surveys we send out to patients on the care they have received.
Prior to implementing this process, I found that I was only documenting the discussion of smoking cessation with my diabetic patients only 20 percent of the time. My history intake form contains questions on tobacco use but these questions somehow did not get translated into the dictated and/or written notes. However, with the EHR that is formatted to ask these questions that either my patient fills out or my assistant fills in, I now have documentation 100 percent of the time. The fact that I have counseled the patient on smoking cessation is clearly noted. This helps with the total care of a patient who has diabetes, whom I may be treating for a nonhealing wound.
My job as a clinician is to use the evidence presented at national meetings to improve the outcomes of my patients. This may mean using a combination of modalities for the right patient at the right time. I also may be positioned to take advantage of the programs that CMS or private insurance plans may be implementing in the near future regarding an alternative method of reimbursement or supplemental reimbursement for providing what is now perceived as quality of care.
Podiatric physicians can apply this type of process to other patients as well. I am using the heel pain protocol introduced by the American College of Foot and Ankle Orthopedics and Medicine (ACFAOM) with the patient recall portion of my EHR and its health maintenance section to track the outcomes of the treatment plans I initiate for my patients. The system also enables me to follow an evidence-based approach to care with these patients.
1. Centers for Disease Control and Prevention. National Diabetes Fact Sheet, 2005.
2. American Diabetes Association. Diabetes Statistics, www.diabetes.org.
3. Reiber GE, Boyko EJ, Smith DG. Lower extremity foot ulcers and amputations in diabetes. In: Diabetes in America, 2nd edition. Harris MI, ed., U.S. Government Printing Office, Washington, DC, 1995.
4. Centers for Disease Control and Prevention. The public health burden of diabetes mellitus in the United States. In Diabetes Surveillance, 1997. Atlanta, GA, U.S. Department of Health and Human Services, Public Health Service, 1997
5. Jiwa F. Diabetes in the 1990s—an overview. Stat Bull Metrop Insur Co 78(1):2–8, 1997.
6. Plaque excision in the peripheral vasculature. Supplement to Endovascular Today. 2004;1-11.
7. Armstrong DG, Lavery LA, Wu S, Boulton AJM. Evaluation of removable and irremovable cast walkers in the healing of diabetic foot wounds. Diabetes Care 28:551-554, 2005.