People at risk for diabetic foot ulcer (DFU) often misunderstand why foot ulcers develop and what self-care strategies may help prevent them. The etiology of DFU is complex and difficult to communicate to patients, which may hinder effective self-care. Thus, we propose a simplified model of DFU etiology and prevention to aid communication with patients. The Fragile Feet & Trivial Trauma model focuses on two broad sets of risk factors: predisposing and precipitating. Predisposing risk factors (eg, neuropathy, angiopathy, and foot deformity) are usually lifelong and result in “fragile feet.” Precipitating risk factors are usually different forms of everyday trauma (eg, mechanical, thermal, and chemical) and can be summarized as “trivial trauma.” We suggest that the clinician consider discussing this model with their patient in three steps: 1) explain how a patient’s specific predisposing risk factors result in fragile feet for the rest of life, 2) explain how specific risk factors in a patient’s environment can be the trivial trauma that triggers development of a DFU, and 3) discuss and agree on with the patient measures to reduce the fragility of the feet (eg, vascular surgery) and prevent trivial trauma (eg, wear therapeutic footwear). By this, the model supports the communication of two essential messages: that patients may have a lifelong risk of ulceration but that there are health-care interventions and self-care practices that can reduce these risks. The Fragile Feet & Trivial Trauma model is a promising tool for aiding communication of foot ulcer etiology to patients. Future studies should investigate whether using the model results in improved patient understanding and self-care and, in turn, contributes to lower ulceration rates.
A prospective study was performed to examine the performance of bone scintigraphy in the earliest stage of soft-tissue foot ulceration with potential risk for progression to osteomyelitis. Twenty-three podiatry clinic patients with new or recurrent foot ulcers but negative plain film radiographs of the foot underwent 24 (one patient was studied twice) multiphase bone scans (flow, blood pool, and 3- and 24-hour delayed images) that were visually scored for severity of increased uptake on a scale of 0 to 3+, with 0 indicating normal and 3+ indicating severe. Twenty-one scans (88%) showed abnormal uptake on at least one phase, with 17 (71%) having increased bone uptake on late images. Ulcer healing without complications occurred in 20 cases (83%), whereas 4 cases had adverse outcomes, 3 requiring surgical resection for failure to heal and 1 having radiographic progression to frank osteomyelitis. All three patients whose bone scans showed severe abnormal uptake had an adverse clinical outcome. (J Am Podiatr Med Assoc 93(2): 91-96, 2003)
Background: We sought to examine the economic value of specialized lower-extremity medical care by podiatric physicians in the treatment of diabetic foot ulcers by evaluating cost outcomes for patients with diabetic foot ulcer who did and did not receive care from a podiatric physician in the year before the onset of a foot ulcer.
Methods: We analyzed the economic value among commercially insured patients and Medicare-eligible patients with employer-sponsored supplemental medical benefits using the MarketScan Databases. The analysis consisted of two parts. In part I, we examined cost or savings per patient associated with care by podiatric physicians using propensity score matching and regression techniques; in part II, we extrapolated cost or savings to populations.
Results: Matched and regression-adjusted results indicated that patients who visited a podiatric physician had $13,474 lower costs in commercial plans and $3,624 lower costs in Medicare plans during 2-year follow-up (P < .01 for both). A positive net present value of increasing the share of patients at risk for diabetic foot ulcer by 1% was found, with a range of $1.2 to $17.7 million for employer-sponsored plans and $1.0 to $12.7 million for Medicare plans.
Conclusions: These findings suggest that podiatric medical care can reduce the disease and economic burdens of diabetes. (J Am Podiatr Med Assoc 101(2): 93–115, 2011)
Introduction: A study of 72 subjects conducted in the European Union and Australia assessed the safety and efficacy of Apligraf (Organogenesis, Inc, Canton, Massachusetts), a bilayered cell therapy composed of living keratinocytes and living fibroblasts in the treatment of non-infected, diabetic foot ulcers (DFU). The design and patient population of this study were similar to a 208-subject United States study (Veves et al., 2001), which led to FDA approval of Apligraf for the treatment of DFU. EU patient outcomes were compared and contrasted to established US-based patient outcome parameters.
Methods: Subjects with a non-infected neuropathic diabetic foot ulcer present for at least two weeks were enrolled in these prospective, multicenter, randomized, controlled, open-label studies that compared Apligraf used in conjunction with standard therapy (sharp debridement, standard wound care, and off-loading) against standard therapy alone.
Results: The design, conduct, and patient populations of the EU and US studies were comparable. Pooling of data was able to be performed because of the similarity and consistency of the two studies. Efficacy and safety results remained consistent across studies independent of mean ulcer duration that was significantly longer in the EU study (21 months, compared to 10 months in the US). Reported adverse events through 12 weeks were comparable across treatment groups in the two studies. Multiple efficacy measures consistently demonstrated superiority of Apligraf treatment over control treated groups in both studies. Combining the data from both studies, 55.2% (80/145) of Apligraf subjects had complete would closure by 12 weeks, compared to 34.3% (46/134) of Control subjects (P = 0.0005; Fisher3s exact test), and Apligraf subjects had a significantly shorter time to complete wound closure (P = 0.0004; log-rank test).
Conclusions: Both the EU and US studies exhibited superior efficacy and comparable safety for subjects treated with Apligraf compared to control treated subjects. The similar outcomes of the two studies provide robust, consistent evidence of the benefit of Apligraf in treating geographically disparate DFU patient populations.
A universally accepted histopathologic classification of diabetic foot osteomyelitis does not currently exist. We sought to evaluate the histopathologic characteristics of bone infection found in the feet of diabetic patients and to analyze the clinical variables related to each type of bone infection.
We conducted an observational prospective study of 165 diabetic patients with foot ulcers who underwent surgery for bone infection. Samples for microbiological and histopathologic analyses were collected in the operating room under sterile conditions.
We found four histopathologic types of osteomyelitis: acute osteomyelitis (n = 46; 27.9%), chronic osteomyelitis (n = 73; 44.2%), chronic acute osteomyelitis (n = 14; 8.5%), and fibrosis (n =32; 19.4%). The mean ± SD time between the initial detection of ulcer and surgery was 15.4 ± 23 weeks for acute osteomyelitis, 28.6 ± 22.4 weeks for chronic osteomyelitis, 35 ± 31.3 weeks for chronic acute osteomyelitis, and 27.5 ± 27.3 weeks for the fibrosis stage (analysis of variance: P = .03). Bacteria were isolated and identified in 40 of 46 patients (87.0%) with acute osteomyelitis, 61 of 73 (83.5%) with chronic osteomyelitis, 11 of 14 (78.6%) with chronic acute osteomyelitis, and 25 of 32 (78.1%) with fibrosis.
Histopathologic categorization of bone infections in the feet of diabetic patients should include four groups: acute, chronic, chronic acute, and fibrosis. We suggest that new studies should identify cases of fibrosis to allow comparison with the present results. (J Am Podiatr Med Assoc 103(1): 24–31, 2013)
Ablative fractional laser is suggested to promote wound healing in diabetic and venous leg ulcers. In this article, we report the treatment outcome of a recalcitrant foot ulceration related to lower leg arteriopathy. A 43-year-old man with typical digital substraction angiographic findings of arteriopathy was admitted to our department after 30 sessions of hyperbaric oxygen therapy. There was heterotopic tissue within the ulcer consistent with osseous metaplasia and mature bone tissue. This tissue was removed with full-field erbium:yttrium-aluminum-garnet laser, and the remaining parts received fractional erbium:yttrium-aluminum-garnet laser for the induction of wound healing. A decrease in ulcer dimensions was achieved by the second month of laser interventions without recurrence in the first-year control.
We assessed the efficacy of customized foot orthotic therapy by comparing reulceration rates, minor amputation rates, and work and daily living activities before and after therapy. Peak plantar pressures and peak plantar impulses were compared with the patients not wearing and wearing their prescribed footwear.
One hundred seventeen patients with diabetes were prescribed therapeutic insoles and footwear based on the results of a detailed biomechanical study and were followed for 2 years. All of the patients had a history of foot ulcers, but none had undergone previous orthotic therapy.
Before treatment, the reulceration rate was 79% and the amputation rate was 54%. Two years after the start of orthotic therapy, the reulceration rate was 15% and the amputation rate was 6%. Orthotic therapy reduced peak plantar pressures in patients with reulcerations and in those without (P < .05), although a significant decrease in peak plantar impulses was achieved only in patients not experiencing reulceration. Sick leave was reduced from 100% to 26%.
Personalized orthotic therapy targeted at reducing plantar pressures by off-loading protects high-risk patients against reulceration. Treatment reduced the reulceration rate and peak plantar pressures, leading to patients’ return to work or other activities. (J Am Podiatr Med Assoc 103(4): 281-290, 2013)
Background: Diabetic foot ulcers (DFUs) are the main cause of hospitalizations and amputations in diabetic patients. Failure of standard foot care is the most important cause of impaired DFU healing. Dakin’s solution (DS) is a promising broad-spectrum bactericidal antiseptic for management of DFUs. Studies investigating the efficacy of using DS on the healing process of DFUs are scarce. Accordingly, this is the first evidence-based, randomized, controlled trial conducted to evaluate the effect of using diluted DS compared with the standard care in the management of infected DFUs.
Methods: A randomized controlled trial was conducted to assess the efficacy of DS in the management of infected DFUs. Patients were distributed randomly to the control group (DFUs irrigated with normal saline) or the intervention group (DFUs irrigated with 0.1% DS). Patients were followed for at least 24 weeks for healing, reinfection, or amputations. In vitro antimicrobial testing on DS was performed, including determination of its minimum inhibitory concentration, minimum bactericidal concentration, minimum biofilm inhibitory concentration, minimum biofilm eradication concentration, and suspension test.
Results: Replacing normal saline irrigation in DFU standard care with 0.1% DS followed by soaking the ulcer with commercial sodium hypochlorite (0.08%) after patient discharge significantly improved ulcer healing (P < .001) and decreased the number of amputations and hospitalizations (P < .001). The endpoint of death from any cause (risk ratio, 0.13; P = .029) and the amputation rate (risk ratio, 0.27; P < .001) were also significantly reduced. The effect on ulcer closure (OR, 11.9; P < .001) was significantly enhanced in comparison with the control group. Moreover, DS irrigation for inpatients significantly decreased bacterial load (P < .001). The highest values for the in-vitro analysis of DS were as follows: minimum inhibitory concentration (MIC), 1.44%; minimum bactericidal concentration (MBC), 1.44%; minimum biofilm inhibitory concentration (MBIC), 2.16%; and minimum biofilm eradication concentration (MBEC), 2.87%.
Conclusions: Compared with standard care, diluted DS (0.1%) was more effective in the management of infected DFUs. Dakin’s solution (0.1%) irrigation with debridement followed by standard care is a promising method in the management of infected DFUs.
Background: Diabetic foot ulceration is a severe complication of diabetes characterized by chronic inflammation and impaired wound healing. This study aimed to evaluate the effect of a medical device gel based on adelmidrol + trans-traumatic acid in the healing process of diabetic foot ulcers.
Methods: Thirty-seven diabetic patients with foot ulcers of mild/moderate grade were treated with the gel daily for 4 weeks on the affected area. The following parameters were evaluated at baseline and weekly: 1) wound area, measured by drawing a map of the ulcer and then calculated with photo editing software tools, and 2) clinical appearance of the ulcer, assessed by recording the presence/absence of dry/wet necrosis, infection, fibrin, neoepithelium, exudate, redness, and granulation tissue.
Results: Topical treatment led to progressive healing of diabetic foot ulcers with a significant reduction of the wound area and an improvement in the clinical appearance of the ulcers. No treatment-related adverse events were observed.
Conclusions: The results of this open-label study show the potential benefits of adelmidrol + trans-traumatic acid topical administration to promote reepithelialization of diabetic foot ulcers. Further studies are needed to confirm the observed results.
Diabetic Foot Ulcers Treated with Becaplermin and TheraGauze, a Moisture-Controlling Smart Dressing
A Randomized, Multicenter, Prospective Analysis
Background: It is hypothesized that moisture regulation specific to the area of contact results in local wound conditions more amenable to healing, which would result in faster and more frequent wound closure. TheraGauze is a new polymer-impregnated dressing designed to regulate moisture to a varying degree over the entire surface of a wound.
Methods: This prospective, randomized, multicenter study examined outcomes from treatment of diabetic foot ulcers with TheraGauze and TheraGauze in conjunction with becaplermin. We also compared these outcomes with historical data from the literature that used saline-moistened gauze and becaplermin.
Results: The rates of wound closure with TheraGauze and TheraGauze + becaplermin were 0.37 and 0.41 cm2/week, respectively (P = .34). The difference between these values was not statistically significant. We also observed high closure rates at 12 weeks (46.2% in both groups) and 20 weeks (61.5% with TheraGauze alone and 69.2% with TheraGauze + becaplermin). These data were also compared with historical data for closure rates (0.18 cm2/week) and percentage of wounds closed using saline-moistened gauze alone and becaplermin with saline-moistened gauze (0.24 cm2/week) from a variety of studies.
Conclusions: Wounds in which moisture content was regulated with TheraGauze showed more rapid change in wound area and a higher percentage of wounds achieving closure at 12 and 20 weeks regardless of whether becaplermin was used. (J Am Podiatr Med Assoc 100(3): 155–160, 2010)