Chronic Wounds

Chronic cutaneous ulcers (CCUs) are wounds that fail to heal in a timely fashion and include diabetic foot ulcers (DFU), pressure ulcers (PU), and venous leg ulcers (VLU). CCUs affect over 6 million Americans annually, cost well over $25 billion in direct treatment costs (with newer estimates suggesting even higher costs) and have greater mortality than many cancers (Table 1).1,2 Patients with CCUs are complicated medically, suffering from many comorbidities.1 CCUs are painful, malodorous, leak fluid, and decrease mobility, and cause anger, resentment, fear, social isolation, and depression. Medical education pertaining to CCUs is limited, and a defined wound care specialty does not exist. Additionally, the federal research budget fails to match the public health-care cost of the disease, and the US Food and Drug Administration (FDA) has approved few drugs to treat CCUs. CCUs are prevalent, lethal, and costly; however, public awareness, research funding, stimulus for innovation, and patient and physician education is lacking.TABLE 1: “Chronic Wound Prevalence, Severity and Cost”CHRONIC WOUND PREVALENCE, SEVERITY, AND COST Diabetic Foot Ulcers The annual US incidence of DFUs is 1.5 million.1 One in 4 patients with diabetes mellitus develop a DFU, and of the one-third that heal with standard of care, two-thirds will recur.1,3 As a result, nearly 1 of 6 patients with DFUs require an amputation.1 Patients with neuropathic DFUs have a higher 5-year mortality risk (45%–55%) than patients with Hodgkin disease (18%), breast cancer (18%), and prostate cancer (8%).2 Patients with DFUs do not simply have more advanced disease than patients without DFUs. Although ischemic cardiopathy is the most common cause of death,4 data suggest that DFUs increase the risk for lower extremity amputation and death, independent of diabetes control, peripheral arterial disease, and heart disease.5 Furthermore, treatment of DFUs require an additional direct $13 billion annually.3 Pressure Ulcers More than 2.5 million PUs are treated in US acute care facilities annually,1 with nearly 1 in 4 critical care patients developing PUs.1 Due to the proximity of PUs to boney prominences, osteomyelitis is a frequent complication. Osteomyelitis can lead to septicemia, which is associated with 55% mortality.2 Having a PU increases mortality by 7.23% and hospital-acquired PUs cause 60,000 deaths annually, mostly due to infection.1 Among those dying from PUs, 40% were associated with septicemia.6 PUs cause an additional average cost per hospital stay of $43,180.1 Each PU costs $70,000 to treat, leading to a cost of $11 billion annually.1 Venous Leg Ulcers VLUs affect 2.2 million Americans.1 Less than two-thirds of VLUs heal by 24 weeks, and many recur.1,3 VLUs can be complicated by cellulitis, lymphangitis, osteomyelitis, and malignant change. Treating VLUs costs $14.9 billion each year, primarily due to hospitalizations and physician office visits among privately insured patients. Home health care and prescription drugs represent an additional significant portion of these costs among Medicare patients.3 EDUCATION GAPS Provider Education Although CCUs are prevalent, lethal, and costly, significant gaps in wound care education exist. In Canada, 80% of physicians rate their ability to recognize and manage a wound infection and the need for debridement as poor to fair; 70% desire to improve their wound care knowledge.7 US medical students receive on average less than 5 hours of formal wound care training.1 Moreover, in a survey of US medical schools, only 7 schools provide a formal wound healing elective.8 To reduce this gap, more medical schools should provide wound healing electives to allow medical students to graduate with wound healing knowledge. This exposure may compel students to pursue a career in wound healing. However, post-graduate training is also limited, as should students desire advanced training, only 1 clinical fellowship in wound healing exists and is not Accreditation Council for Graduate Medical Education approved. Formal Accreditation Council for Graduate Medical Education -approved wound healing fellowships need to evolve to facilitate, physician training in therapies to treat the complex array of CCUs. More talented physicians entering the wound healing force in conjunction with skilled wound care nurses and physician assistants may hasten the field's advancement and improve patient care. Physicians may be discouraged from entering the wound healing force due to suboptimal reimbursement, creating barriers to the provision of excellent wound care. However, this may change as reimbursement policies convert from volume and procedure-focused criteria to outcome-based criteria. These new reimbursement criteria may also facilitate increased development of multidisciplinary wound healing centers (MWHC), comprised of skilled wound care nurses, internists, surgeons, podiatrists, hyperbaric specialists, dermatologists, and others to treat patients’ wounds along with their contributing comorbidities. MWHC have been shown to enhance outcomes in CCU patients, such as amputation-free survival in chronic critical limb ischemia patients.9 Patient Education Patients with CCUs also need wound care education. Only 27% of patients with VLUs know leg compression is the standard of care, which may contribute to the high (20%–90%) nonadherence rate to compression therapy.10 Knowledgeable physicians, nurse practitioners, and allied health personnel must educate CCU patients of the importance of the treatment modalities to improve adherence and outcomes. Furthermore, if the public was widely aware, for instance, of the skin changes associated with venous disease, patients would be prompted to ask their physicians whether to initiate wearing compression stockings to prevent initial ulceration, much like the public is aware of recommended annual mammograms for breast cancer screening. A “Chronic Wound Awareness Month” would help bring the disease into public conversation and promote CCU education. We hope to see more extensive patient education provided by a variety of competent health-care professionals collaborating in MWHCs. These improvements combined with a society widely aware of CCUs may lead to decreased incidence in CCUs, improved treatment outcomes, and lessened severity of disease. WOUND RESEARCH FUNDING DISPARITIES Funding for wound research is disproportionately low. In 2012, $30 million from the National Institutes of Health went to cutaneous wound healing research. Chronic wounds received 0.1% of the overall federal budget of $41 billion, though conservative estimates have CCUs costing $25 billion, or 0.9% of the National Health Expenditure. Conversely, Lyme disease, a less common and 10 times less economically burdensome disease than CCUs, received the same proportional amount of funding as CCUs.3 Though research funding for underlying disease processes such as diabetes mellitus, may indirectly affect DFUs, with the existing research funding, CCUs independently are a severe and growing public health issue. Additional research funding proportionate to the health-care burden of CCUs is warranted. Since the time to see the effect of increased research is long, establishing national wound healing treatment registries would provide expedited therapy effectiveness data, which clinicians could utilize real time. CHRONIC WOUND DRUG DEVELOPMENT AND THE FOOD AND DRUG ADMINISTRATION The FDA CCU drug approval process creates unnecessary hurdles. Only 1 drug and 2 class III devices have been FDA approved for healing CCUs, and since 1997, there have been no new FDA approvals targeting CCUs.2 The FDA's 2006 “Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds—Developing Products for Treatment” largely regulates clinical trial design including acceptable primary efficacy end points. The primary end point accepted by the FDA is complete wound closure whereas surrogate end points are not accepted.2 Conversely, the FDA's 2007 “Guidance for Industry Clinical Trial End points for the Approval of Cancer Drugs and Biologics” accepts 3 efficacy end points: overall survival, tumor assessments, and symptom assessment; the 5 “tumor assessments” are surrogate end points, which even qualify for FDA accelerated approval.2 Thus, trials investigating cancer therapeutics can seek FDA approval based on various outcomes, whereas CCU therapies are limited to complete epithelialization, even though CCUs have associated mortality comparable to many cancers. A cancer drug can gain FDA approval for decrease in tumor size, but CCU-targeted therapy cannot obtain FDA approval for wound size reduction. At least 4 clinical trials of various growth factors demonstrated a statistically significant decrease in ulcer area, but were not approved.2 Randomized trials evaluating the clinical benefit of surrogate or intermediate end points for wound healing are lacking, though it is known that wound reduction is prognostic for complete healing.2 The FDA drug approval process presents a general challenge for all medical fields; however, the FDA should modify its position on CCU drug approval end points as was done for cancer therapies, due to CCU prevalence, severity, and health-care cost. CONCLUSIONS It is critical to improve both health-care provider and patient wound care education. The funding for and development of novel, evidence-based therapies must be a priority, with an expedited approval process and clinically relevant end points developed. With the support of a variety of health-care professionals both in and outside of the wound care field, as well as governmental agencies, medical academic institutions and the general public, we can promote an appropriate awareness and knowledge of chronic wounds and their associated complications to improve patient outcomes. We can improve the quality and quantity of life of millions of patients by increasing physicians’ competency and collaboration in managing CCUs with the currently available therapies and by novel, innovative treatments.

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