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Diabetic Foot Ulcer
Diabetic foot ulcers are the most common foot injuries leading to lower extremity amputation. Family physicians have a pivotal role in the prevention or early diagnosis of diabetic foot complications.
The Inter-rater Reliability of the Clinical Signs and Symptoms Checklist in Diabetic Foot Ulcers
The Clinical Signs and Symptoms Checklist is a tool designed to measure 12 clinical signs and symptoms of localized chronic wound infection. Since its initial development, this Checklist has been revised to include sanguineous drainage. To examine the inter-rater reliability of the revised Clinical Signs and Symptoms Checklist in diabetic foot ulcers, an observational, cross-sectional study was conducted in conjunction with a larger study examining the validity of each sign and symptom for identifying infection in diabetic foot ulcers. Two independent nurse observers assessed 64 diabetic foot ulcers in 64 patients using the Checklist. The reliability of each item was calculated using percent agreement and the Kappa coefficient. Total percent agreement ranged from 76% to 100%, and Kappa statistics ranged from .34 to 1.00. Study findings confirm that the Clinical Signs and Symptoms Checklist is a reliable tool for identifying the clinical signs and symptoms of localized infection in diabetic foot ulcers. KEYWORDS: wound infection, foot ulcer, diabetic foot, clinical signs and symptoms
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Risk Factors Associated with Healing Chronic Diabetic Foot Ulcers: The Importance of Hyperglycemia
Diabetic foot ulcer management presents a significant challenge for wound care clinicians; numerous approaches to encourage healing in these difficult wounds have been explored. To determine risk factors related to diabetic foot ulcer time to healing and closure, a secondary analysis of data from a prospective randomized study involving 245 patients treated with a bioengineered human dermal substitute (n = 130) or control treatment (n = 115) was conducted. Analyzed variables included age, race, gender, ulcer duration, initial ulcer size, initial hemoglobin (HgbA1c), average HgbA1c, change in HgbA1c, diabetes type, average hours of weight-bearing, study ulcer infection, history of smoking or alcohol use, and laboratory values. Time to healing was significantly affected by initial ulcer size (risk ratio 0.75, confidence interval 0.59?0.96), gender (risk ratio 2.01, confidence interval 1.20?3.40), and wound infection during the study (risk ratio 2.9, confidence interval 1.45?4.22). Initial ulcer size (>2 cm2), male gender, and an episode of infection during the study were associated with an increased risk of nonclosure after 12 weeks of care (P <0.05). In patients whose HgbA1C increased during the study (n = 101), 20.7% of all wounds and 21% of dermal substitute-managed wounds (n = 105) healed; whereas, in patients whose HgbA1C levels remained stable or decreased, 26.3% of all wounds and 47% of dermal substitute-managed wounds healed (P <0.05). Female gender, small ulcer size, and the absence of infection were found to have a positive effect on healing all diabetic foot ulcers; improved glucose control had a significant effect on healing wounds managed with the dermal substitute only. This is the first diabetic foot ulcer study to find a relationship between hyperglycemia and wound healing. Further research into factors that improve healing of wounds, including diabetic foot ulcers, is warranted. KEYWORDS: diabetes mellitus, foot ulcers, healing, risk factors, hyperglycemia
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Ultrasound Therapy for Recalcitrant Diabetic Foot Ulcers: Results of A Randomized, Double-Blind, Controlled, Multicenter Study?Part 2
Part 2 - Discussion The ultrasound therapy described in this study employs a recently FDA-cleared device for the cleansing and debridement of wounds with an expanded indication (promotes healing). An attempt was made to design a trial that addressed many of the previous shortcomings of both ultrasound and diabetic foot ulcer studies. Conclusion Ultrasound therapy has...
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Validation of Wagner's Classification: A Literature Review
To ensure high quality care, practitioners should base their practice on sound clinical evidence. Relying on quantitative measurements when evaluating this evidence demands measurement accuracy, reliability, and validity. Current diabetic foot ulcer classification systems include: Meggitt's, Wagner's, Knighton's, Pecoraro's, University of Texas San Antonio Diabetic Wound Classification, and Size (Area and Depth), Sepsis, Arteriopathy, and Denervation. Of these, the Wagner's classification system is the most widely used to describe the natural history of the dysvascular foot, even though evidence of its validity and reliability are lacking. A review of clinimetric properties and existing validation literature of the other diabetic classification systems suggest that the University of Texas San Antonio Diabetic Wound Classification and S(AD) SAD have the potential to fill the current void, once additional studies have been conducted.
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Ultrasound Therapy for Recalcitrant Diabetic Foot Ulcers: Results of A Randomized, Double-Blind, Controlled, Multicenter Study?Part 1
An estimated 15% of patients with diabetes will develop a foot ulcer sometime in their life, making them 30 to 40 times more likely to undergo amputation due to a non-healing foot ulcer than the non-diabetic population. To determine the safety and efficacy of a new, non-contact, kilohertz ultrasound therapy for the healing of recalcitrant diabetic foot ulcers ? as well as to evaluate the impact on total closure and quantitative bacterial cultures and the effect on healing of various levels of sharp/surgical debridement ? a randomized, double-blinded, sham-controlled, multicenter study was conducted in hospital-based and private wound care clinics. Patients (55 met criteria for efficacy analysis) received standard of care, which included products that provide a moist environment, offloading diabetic shoes and socks, debridement, wound evaluation, and measurement. The ?therapy? was either active 40 KHz ultrasound delivered by a saline mist or a ?sham device? which delivered a saline mist without the use of ultrasound. After 12 weeks of care, the proportion of wounds healed (defined as complete epithelialization without drainage) in the active ultrasound therapy device group was significantly higher than that in the sham control group (40.7% versus 14.3%, P = 0.0366, Fisher?s exact test). The ultrasound treatment was easy to use and no difference in the number and type of adverse events between the two treatment groups was noted. Of interest, wounds were debrided at baseline followed by a quantitative culture biopsy. The results of these cultures demonstrated a significant bioburden (>105) in the majority of cases, despite a lack of clinical signs of infection. Compared to control, this therapeutic modality was found to increase the healing rate of recalcitrant, diabetic foot ulcers. KEYWORDS: ultrasound, debridement, diabetic foot ulcer, randomized controlled trial, wound modalities Ostomy/Wound Management 2005;51(8):24?39
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A Prospective, Randomized, Controlled Trial of Autologous Platelet-Rich Plasma Gel for the Treatment of Diabetic Foot Ulcers
Nonhealing diabetic foot ulcers are a common cause of amputation. Emerging cellular therapies such as platelet-rich plasma gel provide ulcer management options to avoid loss of limb. The purpose of this prospective, randomized, controlled, blinded, multicenter clinical study was to evaluate the safety and efficacy of autologous platelet-rich plasma gel for the treatment of nonhealing diabetic foot ulcers. One hundred, twenty-nine (129) patients were screened; 72 completed a 7-day screening period and met the study inclusion criteria. Patients were randomized into two groups ? the standard care with platelet-rich plasma gel or control (saline gel) dressing group ? and evaluated biweekly for 12 weeks or until healing. Healing was confirmed 1 week following closure and monitored for another 11 weeks. An independent audit led to the exclusion of 32 patients from the final per-protocol analysis because of protocol violations and failure to complete treatment. In this group, 13 out of 19 (68.4%) of the platelet-rich plasma gel and nine out of 21 (42.9%) of the control wounds healed. After adjusting for wound size outliers (n = 5), significantly more platelet-rich plasma gel (13 out of 16, 81.3%) than control gel (eight out of 19, 42.1%) treated wounds healed (P = 0.036, Fisher?s exact test). Kaplan-Meier time-to-healing also was significantly different between groups (log-rank, P = 0.0177). No treatment-related serious adverse events were reported and bovine thrombin used in the preparation of PRP did not cause Factor V inhibition. When used with good standards of care, the majority of nonhealing diabetic foot ulcers treated with autologous platelet-rich plasma gel can be expected to heal.
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Searching for Evidence-Based Medicine in Wound Care: An Introduction
During the last 10 years, wound care knowledge and treatment options, as well as the amount of information in the literature pertaining to wound and patient treatment options, have expanded rapidly. As a result, clinicians need to be able to review the existing literature with knowledge of the steps involved in evidence-based medicine. By identifying search strategies to improve information retrieval, time can be saved, new knowledge can be obtained, and with an understanding of clinical experience and patient-centered concerns, the best evidence for decision making can be utilized. The information retrieved can be categorized according to the level of evidence and clinical practice guidelines (documents in which an expert panel has reviewed the evidence and interpreted it for patient care) can be measured by the Appraisal of Guidelines for Research and Evaluation (AGREE) Instrument. Learning how to find and interpret the literature not only enhances clinical decision making, but it also may inspire additional inquiries that will add to the existing evidence base.
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Pain in Diabetic Foot Ulcers
People with diabetes who have foot ulcers require adequate vasculature, infection control, and pressure offloading to heal. Pain is uncommon in diabetic foot disorders, but it may herald the onset of limb-threatening complications such as deep infection, Charcot change, or critical ischemia. Although neuropathy is most commonly painless, a minority of patients experience disturbing burning, stinging, stabbing, or shooting sensations. Using the "preparing the wound bed" model, the cause of pain in the person with diabetic foot problems can be diagnosed systematically and important therapeutic measures can be instituted in an attempt to prevent potential complications, including amputation.
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Diabetic Heel Ulcers: A Major Risk Factor for Lower Extremity Amputation
Of all the ulcers seen in patients with diabetes, heel ulcers are the most serious and often lead to below-the-knee amputation. Management of heel ulcers requires a thorough knowledge of the major risk factors for ulceration in the heel area and a standardized program of local ulcer care, metabolic control, early control of infection, and improvement of blood supply to the foot. The most common risk factors for ulceration in the heel region include immobility of the lower limbs, diabetic neuropathy, structural deformity, and peripheral arterial occlusive disease. Patient education regarding foot hygiene, skin care, and proper footwear is crucial to reducing the risk of an injury that can lead to heel ulceration. A careful foot examination that tests for neuropathy and arterial insufficiency can identify patients at risk for heel ulcers and appropriately classify patients with ulcers into different grades to design proper therapeutic plans for management. Team management programs that focus on education, prevention, regular foot examinations, aggressive intervention, and proper use of therapeutic measures can significantly reduce the risk of lower-extremity amputations from heel ulcers. Keywords: heel ulcers, diabetes, offloading pressure, lower extremity amputation
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Living with Diabetic Foot Ulcers: A Life of Fear, Restrictions, and Pain
Lower extremity ulcers are a common and challenging problem for people with diabetes and clinicians who provide their care. A qualitative study of seven patients with type 1 or type 2 diabetes who had leg and/or foot ulcers was conducted to enhance understanding of the patient's perspective of living with lower extremity ulcers and diabetes. Data were collected through in-depth interviews guided by the patients' descriptive priorities. Results indicated that patients experienced changes in their feet, pain and insomnia, fatigue and limited mobility, social isolation and loneliness, a restricted life, loss of control, and fear for the future. When treating a patient's leg or foot ulcer, clinicians need to consider patients' subjective feelings toward the various aspects of their life situations and the impact of their situation on their quality of life. Understanding the ramifications of lower extremity ulcers and diabetes on patients is important to the health professional's ability to provide support during the illness process.
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