Background: This study reevaluates the previously reported subjective benefits of surgical nerve decompression in diabetes with an easily observable, fully objective outcome measure to eliminate the placebo effect and observer bias.
Methods: A retrospective review was conducted of a series of 75 feet in 65 patients with diabetes and previous neuropathic ulcer who had surgical decompressions of the peroneal and posterior tibial nerve branches at anatomical fibro-osseous tunnels. After a minimum of 12 months of follow-up, the incidence of ipsilateral ulcer was assessed.
Results: Postoperatively, four ulcer recurrences and four new-site ulcers developed in 187 patient-years. Mean follow-up was 2.49 years (range, 1–13 years). The combined linear annual risk of ipsilateral recurrence and new ulcer is 4.28%, the lowest reported in the scientific literature.
Conclusions: Surgical decompression of lower-extremity nerves of high-risk feet at fibro-osseous anatomical tunnels was followed by a low annual incidence of ulcer recurrence. This objective outcome measure suggests benefits of nerve decompression in diabetic neuropathy, as have previous reports using pain and sensory change as subjective measures. Unrecognized nerve entrapment may frequently coexist with diabetic sensorimotor peripheral neuropathy in patients with diabetic foot ulcer. (J Am Podiatr Med Assoc 100(2): 111–115, 2010)
We sought to develop a consensus statement for the use of off-loading in the management of diabetic foot ulcers (DFUs).
A literature search of PubMed for evidence regarding off-loading of DFUs was initially conducted, followed by a meeting of authors on March 15, 2013, in Philadelphia, Pennsylvania, to draft consensus statements and recommendations using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach to assess quality of evidence and develop strength of recommendations for each consensus statement.
Evidence is clear that adequate off-loading increases the likelihood of DFU healing and that increased clinician use of effective off-loading is necessary. Recommendations are included to guide clinicians on the optimal use of off-loading based on an initial comprehensive patient/wound assessment and the necessity to improve patient adherence with off-loading devices.
The likelihood of DFU healing is increased with off-loading adherence, and, current evidence favors the use of nonremovable casts or fixed ankle walking braces as optimum off-loading modalities. There currently exists a gap between what the evidence supports regarding the efficacy of DFU off-loading and what is performed in clinical practice despite expert consensus on the standard of care.
Background: A comparison of the cost-effectiveness of becaplermin plus good wound care (BGWC) versus good wound care (GWC) alone in treating patients with diabetic foot ulcers (DFUs) may enable physicians and health-care decision makers in the United States to make better-informed choices about treating DFUs, which currently contribute to a substantial portion of the economic burden of diabetes.
Methods: Data from three phase III trials were used to predict expected 1-year costs and outcomes, including the average percentage reduction from baseline in wound surface area (WSA), the direct costs of DFU therapy, and the cost per cm2 of WSA reduction.
Results: At 20 weeks, the BGWC group had a statistically greater probability of complete wound closure than the GWC group (50% versus 35%; P = .015). Based on reported WSA reduction rates, DFUs in the BGWC group were predicted to close by 100% at 27 weeks, and those in the GWC group were predicted to close by 88% at 52 weeks. The GWC group had higher total estimated 1-year direct cost of DFU care ($6,809 versus $4,414) and higher cost per cm2 of wound closure ($3,501 versus $2,006).
Conclusions: Becaplermin plus good wound care demonstrated economic dominance compared with GWC by providing better clinical outcomes via faster reduction in WSA and higher rates of closure at a lower direct cost.
Diabetic foot ulcer (DFU) is well managed by infection control, euglycemic state, and debridement of the ulcer followed by appropriate dressing and off-loading of the foot. Studies show that approximately 90% of DFUs that are properly off-loaded heal in nearly 6 weeks. Platelet-rich plasma (PRP) serves as a growth factor agonist and has mitogenic and chemotactic properties that help in DFU healing. We sought to evaluate the efficacy of local application of PRP with respect to healing rate and ulcer area reduction in treating DFUs.
Sixty noninfected patients with DFUs (plantar surface area, ≤20 cm2; Meggitt-Wagner grades 1 and 2) were randomized to receive normal saline dressing (control group [CG]) or PRP dressing (study group [SG]) along with total-contact casting for 6 weeks or until complete ulcer healing, whichever was earlier. Healing rate and change in ulcer area were evaluated weekly.
Mean ± SD ulcer area at baseline was 4.96 ± 2.89 cm2 (CG) and 5.22 ± 3.82 cm2 (SG) (P = .77), decreasing to 1.15 ± 1.35 cm2 (CG) and 0.96 ± 1.53 cm2 (SG) (P = .432) at 6 weeks. Mean ± SD percentage reduction in healing area at 6 weeks was 81.72% ± 17.2% (CG) and 85.98% ± 13.42% (SG) (P = .29). Mean ± SD healing rate at 6 weeks was 0.64 ± 0.36 cm2 (CG) and 0.71 ± 0.46 cm2 (SG) (P = .734).
The PRP dressing is no more efficacious than normal saline dressing in the management of DFU in conjunction with total-contact casting.
Background: People with diabetic foot ulcers report poor quality of life. However, prospective studies that chart quality of life from the onset of diabetic foot ulcers are lacking. We describe change in quality of life in a cohort of people with diabetes and their first foot ulcer during 18 months and its association with adverse outcomes.
Methods: In this prospective cohort study of adults with their first diabetic foot ulcer, the main outcome was change in Medical Outcomes Study 36-Item Short Form Health Survey scores between baseline and 18-month follow-up. We recorded baseline demographics, diabetes characteristics, depression, and diabetic foot outcomes and mortality at 18 months.
Results: In 253 people with diabetes and their first ulcer, there were 40 deaths (15.8%), 36 amputations (15.5%), 99 recurrences (43.2%), and 52 nonhealing ulcers (21.9%). The 36-Item Short Form Health Survey response rate of survivors at 18 months was 78% (n = 157). There was a 5- to 6-point deterioration in mental component summary scores in people who did not heal (adjusted mean difference, −6.54; 95% confidence interval, −12.64 to −0.44) or had recurrent ulcers (adjusted mean difference, −5.30; 95% confidence interval, −9.87 to −0.73) and a nonsignificant reduction in those amputated (adjusted mean difference, −5.00; 95% confidence interval, −11.15 to 1.14).
Conclusions: Quality of life deteriorates in people with diabetes whose first foot ulcer recurs or does not heal within 18 months. (J Am Podiatr Med Assoc 99(5): 406–414, 2009)
The clinical diagnosis of osteomyelitis is difficult because of neuropathy, vascular disease, and immunodeficiency; also, with no established consensus on the diagnosis of foot osteomyelitis, the reported efficacy of magnetic resonance imaging (MRI) in detecting osteomyelitis and distinguishing it from reactive bone marrow edema is unclear. Herein, we describe a retrospective study on the efficacy of MRI for decision-making accuracy in diagnosing osteomyelitis in diabetic foot ulcers.
Twelve diabetic patients with infected foot ulcers underwent preoperative MRI between January 1, 2008, and December 31, 2011. The findings were compared with the histopathologic features of 67 parts of 45 resected bones, the cut ends of which were also histopathologically evaluated.
Osteomyelitis was disclosed by MRI and histopathologically confirmed in 30 parts. In contrast, bone marrow edema diagnosed by MRI in 29 parts was confirmed in 23; the other six parts displayed osteomyelitis. Among 17 resected bones, 13 cut ends displayed bone marrow edema and four were normal. All of the wounds healed uneventfully.
In the diagnosis of diabetic foot ulcers, osteomyelitis is often reliably distinguished from reactive bone marrow edema, except in special cases.
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)
The increasing resistance of bacteria to antibiotics and the frequency of comorbid conditions of patients make the treatment of diabetic foot infections problematic. In this context, photodynamic therapy could be a useful tool to treat infected wounds. The aim of this study was to evaluate the effect of repeated applications of a phthalocyanine derivative (RLP068) on the bacterial load and on the healing process.
The present analysis was performed on patients with clinically infected ulcers who had been treated with RLP068. A sample for microbiological culture was collected at the first visit before and immediately after the application of RLP068 on the ulcer surface, and the area was illuminated for 8 minutes with a red light. The whole procedure was repeated three times per week at two centers (Florence and Arezzo, Italy) (sample A), and two times per week at the third center (Stuttgart, Germany) (sample B) for 2 weeks.
Sample A and sample B were composed of 55 and nine patients, respectively. In sample A, bacterial load decreased significantly after a single treatment, and the benefit persisted for 2 weeks. Similar effects of the first treatment were observed in sample B. In both samples, the ulcer area showed a significant reduction during follow-up, even in patients with ulcers infected with gram-negative germs or with exposed bone.
RLP068 seems to be a promising topical wound management procedure for the treatment of infected diabetic foot ulcers.
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)
Offloading devices for diabetic foot ulcers (DFU) generally restrict exercise. In addition to traditional health benefits, exercise could benefit DFU by increasing blood flow and acting as thermotherapy. This study functionally evaluated a cycling cleat designed for forefoot DFU.
Fifteen individuals at risk of developing a DFU used a recumbent stationary bicycle to complete one 5-minute cycling bout with the DFU cleat on their study foot and one 5-minute bout without it. Foot stress was evaluated by plantar pressure insoles during cycling. Laser Doppler perfusion monitored blood flow to the hallux. Infrared photographs measured foot temperature before and after each cycling bout.
The specialized cleat significantly reduced forefoot plantar pressure (9.9 kPa versus 62.6 kPa, P < .05) and pressure time integral (15.4 versus 76.4 kPa*sec, P < .05). Irrespective of footwear condition, perfusion to the hallux increased (3.97 ± 1.2 versus 6.9 ± 1.4 tissue perfusion units, P < .05) after exercise. Infrared images revealed no changes in foot temperature.
The specialized cleat allowed participants to exercise with minimal forefoot stress. The observed increase in perfusion suggests that healing might improve if patients with active DFU were to use the cleat. Potential thermotherapy for DFU was not supported by this study. Evaluation of the device among individuals with active DFU is now warranted.