The Frustrating 15: What’s Missing?

  Caroline Fifes’s commentary on the state of healing of venous leg ulcers over the years evoked several questions. She described the “frustrating 15%,” describing the relatively small change in healing rates of this population of patients through the years. This begs the question, how can this be? Our diagnostic skills regarding recognition of atypical ulcers that masquerade as venous ulcers have improved and we have many more advanced and “active” topical approaches in our treatment armamentarium. As Caroline more than adequately noted, wound care professionals know and understand the necessity of adequate compression and many sophisticated options for providing that compression are available.

  What is missing in the care of that frustrating population (the 15%) of refractory ulcers? Although the following ideas might not change outcome statistics, at least five factors must be understood in order to impact refractory ulcerations:
    1. Patient participation
    2. Recognition of the impact of bacteria
    3. Recognition of atypical ulcers
    4. Use of advanced treatments
    5. Defining closure versus healing.Patient Participation

  Chronic venous insufficiency (CVI) is a significant health problem in the US, accounting for 70% to 80% of the approximate 2.5 million people affected with lower extremity ulcers^1,2 The impact on patients and their families, as well as on the healthcare system, are enormous — 5% of patients lose their jobs and 4.6 million US work days are missed each year as a result of venous disease.³

  Patients unable to miss work must choose between a healed wound or keeping their job. Sometimes they are labeled “non-compliant” or “non-adherent” to treatment plans. Perhaps there are times when the plans need changing. This author is not advocating giving in to all patients who do not want to wear a wrap because their designer shoes won’t fit. A better phrase might be “occupationally non-compliant” — patients for whom adhering to treatment plans could result in the loss of the job that puts the food on their table and provides health insurance to reimburse care. To keep patients working, clinicians need to direct patients to compression wraps that accommodate shoes or to alter shoe wear to accommodate the wraps. It is crucial to work with patients to find solutions for these logistical problems. Most heavy boots (eg, construction boots) will still fit with certain two- and three-layer wraps. Narrow dress shoes often won’t fit so a post-op type of shoe may need to be provided. Teaching the patient or a family member to use a reusable wrap is an option, but one that may sacrifice the level of compression achieved. A patient may need to be fitted for successive pairs of compression garments, presenting a potential new set of problems regarding affordability and availability of sequentially smaller hose to promote the continued reduction in edema.

  Weekly patient appointments, generally the norm for changing wraps, also can pose work problems. Caregivers may be required to contact employers to explain the importance of clinic visits. Caregivers also can accommodate the patient by providing early or late appointments.

  There always will be patients unable or unwilling to comprehend the need for compression and the role that they play in their own healing — patients who continue to smoke, patients with diabetes who will not work toward blood glucose control, and patients who remove their wraps “just because.” However, these patients are the exception rather than the rule.

The Impact of Bacteria

  Managing bacterial burden in venous ulceration can be challenging. Venous ulcers characteristically present with high exudate, inflammation, and pain. Clinicians may interpret these signs and symptoms as indications for culture and subsequent medical management, or conversely, dismiss them as unavoidably related to the presence of an ulcer and not requiring treatment. Recognizing the presence of true clinical infection in these patients may be difficult. Serena et al⁴ analyzed the data from a large multicenter clinical trial to determine the accuracy of clinical examination in diagnosing infection in venous leg ulcers. As part of the protocol, quantitative biopsies were performed as part of the screening process. Of 614 screening biopsies, 122 were found to have a colony count ≥106, indicating the presence of infection. Of the 352 patients eventually enrolled in the trial, 26% were found to have infected ulcers despite a lack of clinical symptoms.

  Gardner et al⁵ evaluated different types of wounds and found little correlation between wound bed infection and classic signs of infection. The signs that had positive predictive value were delayed wound healing over time, friability and discoloration of granulation tissue, pocketing at the base of the wound, foul odor, wound breakdown, and increased pain (see figure 1). These studies suggest that there is no substitute for a thorough clinical evaluation, consideration of the wound age at the time of presentation, and close observation of wound progress.

  A current trend is to use topical antimicrobials to reduce bioburden and then switch to some other topical management that does not injure healthy cells or encourage resistance. However, some patients require continued use of a topical antimicrobial agent, occasional oral antibiotics, and in a very rare case, long-term oral antibiotics until they are healed. The importance of clinical judgment cannot be over-emphasized when describing potential issues that may be occurring even with the wraps.

Identification of Atypical Ulcers

  Everyone has evaluated patients whose lower extremity ulcer “was just there one day” or developed when they “hit their leg,” or “scratched their leg in the night.” Often, legs presenting this way have evidence of varicose veins, hemosiderin staining, and edema. Such ulcers that are “dressed up” like a venous ulcer; indeed, the ulcer may be in part related to venous disease. In his many lectures on atypical ulcers, Dr. Robert Kirsner teaches, If it is in an atypical location, with an atypical appearance, an atypical history, and it doesn’t respond in reasonable time to standard treatments, biopsy. A vasculitis and a vasculopathy patient are shown in Figures 2 and 3, respectively. Figure 2 shows a leg with brawny edema, hemosiderin staining, and an ulcer located on the medial aspect of the patient’s ankle. A few additional suspicious ulcers were located on the dorsum of her foot. The ulcer shown in Figure 3, with purpura evident is clearly not typical but not all atypical ulcers are so easy to spot. Clinicians must be vigilant for vasculitis, pyoderma, and cancer, among other conditions. Doing a biopsy is easy, relatively painless, net a wealth of information, and save a great deal of time spent treating an ulcer topically that may need medical or surgical management.

  Note: the clinician must be aware of the presence of co-existing ischemic disease and arteriovascular status.

Use of Advanced Treatments

  As a clinician in a center and hospital with a great deal of managed care where advanced and active products are readily available and early use of these modalities is encouraged, this author is often more limited as to the number of visits than the type of products to use. The clinic initiates use of products such as Oxidized Regenerated Cellulose (ORC)/collagen, ORC collagen with silver, extracellular wound matrix, topical Platelet Derived Growth Factor (PDGF), bilayered living cell therapy, and negative pressure wound therapy (and combinations of these) much earlier than other facilities.

  Can product use be justified? When consideration is given to the long duration of many wounds at the time of presentation and that many patients are compromised by diabetes, scleroderma, radiation, and steroid use, among other factors. aggressive care can be cost effective care.

Closure versus Healing

  Most patients eventually heal. Based on outcome data, the author’s clinic has an 85% healing rate at 12 weeks. At 24 weeks, that number jumps to 93%. However, this database documents wounds that are “resolved.” It is important to differentiate between ulcers that have closed versus healed. In most cases, achieving venous ulcers closure is not nearly has challenging as maintaining durable healing. Keeping patients with venous ulcers healed used to present a dilemma. Maintenance strategies include compression stockings, compression pumps (occasionally), and educating patients on the need for life-long management of their edema but these efforts may be insufficient. A huge step forward for our clinic was the arrival of a vascular surgeon with whom we can partner to help many of our patients achieve long-term healing through venous interventions. These procedures not only aid in healing, but also more importantly may prevent recurrence. All eligible patients have a vascular consult for potential intervention with modalities such as endovenous laser ablation of incompetent perforators or ultrasound-guided sclerotherapy. After years of “revolving door” venous ulcer treatment, the availability of these interventions has made it possible not only to heal patients, but also to keep them healed, hopefully for life.

Conclusion

  Is it possible to get rid of the “frustrating 15%”? Not all venous patients may heal because not all circumstances are within our control. However, the job of the wound care practitioner is to identify those factors that can be controlled.

References

1. Doughty DB, Holbrook R. Lower-extremity ulcers of vascular etiology. In: Bryant RA, Nix DP (eds). Acute and Chronic Wounds: Current Management Concepts, 3rd edition. St. Louis, Mo: Mosby Elsevier;2007.

2. Myers BA. Venous insufficiency ulcers. In: Myers BA (ed). Wound Management Principles and Practice. Upper Saddle River, NJ: Pearson Education Inc;2004.

3. Kalra M, Gloviczki P. Surgical treatment of venous ulcers: role of subfascial endoscopic perforator vein ligation. In: Steed, DL (ed) Surg Clin N Am, 83 (2003)671–705. WB Saunders Company.

4. Serena T, Robson MC, Cooper DM, Ingatius J. Lack of reliability of clinical/visual assessment of chronic wound infection: the incidence of biopsy-proven infection in venous leg ulcers. WOUNDS. 2006;18(7):197–202.

5. Gardner SE, Frantz, RA, Doebbeling BN. The validity of the clinical signs and symptoms used to identify localized chronic wound infection. Wound Repair Regen. 2001; 9(3): 178–186.