Mortality Rates and Diabetic Foot Ulcers
Is it Time to Communicate Mortality Risk to Patients with Diabetic Foot Ulceration?
Five-year mortality rates after new-onset diabetic ulceration have been reported between 43% and 55% and up to 74% for patients with lower-extremity amputation. These rates are higher than those for several types of cancer including prostate, breast, colon, and Hodgkin’s disease. These alarmingly high 5-year mortality rates should be addressed more aggressively by patients and providers alike. Cardiovascular diseases represent the major causal factor, and early preventive interventions to improve life expectancy in this most vulnerable patient cohort are essential. New-onset diabetic foot ulcers should be considered a marker for significantly increased mortality and should be aggressively managed locally, systemically, and psychologically. (J Am Podiatr Med Assoc 98(6): 489–493, 2008)
Methicillin-Resistant Staphylococcus aureus Endocarditis from a Diabetic Foot Ulcer
Understanding and Mitigating the Risk
Diabetic foot infections are a common cause of morbidity and mortality in the United States, and successful treatment often requires an aggressive and prolonged approach. Recent work has elucidated the importance of appropriate therapy for a given severity of diabetic foot infection, and highlighted the ongoing risk such patients have for subsequent invasive life-threatening infection should diabetic foot ulcers fail to heal. The authors describe the case of a man with diabetes who had prolonged, delayed healing of a diabetic foot ulcer. The ulcer subsequently became infected by methicillin-resistant Staphylococcus aureus (MRSA). The infection was treated conservatively with oral therapy and minimal debridement. Several months later, he experienced MRSA bloodstream infection and complicating endocarditis. The case highlights the ongoing risk faced by patients when diabetic foot ulcers do not heal promptly, and emphasizes the need for aggressive therapy to promote rapid healing and eradication of MRSA.
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)
The Management of Diabetic Foot Ulcers Through Optimal Off-Loading
Building Consensus Guidelines and Practical Recommendations to Improve Outcomes
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: Diabetic foot ulcers (DFUs) are main cause of hospitalizations and amputations in diabetic patients. Failure of standard foot care is the most important cause of impaired DFUs healing. Dakin's solution (DS; sodium hypochlorite) is a promising broad spectrum bactericidal antiseptic for DFUs management. Studies investigating the efficacy of using DS solution on DFUs healing process are scarce. Accordingly, this is the first evidence based randomized control trial study conducted to evaluate the effect of using diluted DS compared with the standard care in the management of infected DFUs. Methods: Randomized control trial study was conducted to assess the efficacy of DS in the management of infected DFUs. Patients were randomly distributed to control group (DFUs irrigated with normal saline) and 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 (MIC), minimum bactericidal concentration (MBC), minimum biofilm inhibitory concentration (MBIC), minimum biofilm eradication concentration (MBEC) 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< 0.001) and decreased number of amputations and hospitalizations (p< 0.001). The endpoint of death from any cause (RR 0.13; p = 0.029) and the amputation rate (RR 0.27; p<0.001) were also significantly reduced. The effect on ulcer closure (OR 11.9; p<0.001) was significantly enhanced in comparison to the control group. Moreover, DS irrigation for inpatients, significantly decreased bacterial load (p< 0.001), The in-vitro analysis results of DS were: MIC (1.44%), MBC (2.88%), MBIC (1.08%) and MBEC (2.87%). Conclusions: Compared with standard care, diluted DS (0.1%) was more effective in the management of infected DFUs. DS (0.1%) irrigation with debridement followed by standard care is a promising method in the management of infected DFUs.
Studies have been conducted to evaluate the efficacy of dehydrated human amnion chorion membrane (dHACM) in treating recalcitrant diabetic foot ulcers. A literature search was performed to review the data collected from the use of dHACM allografts. Two products were explicitly named in these publications, EpiFix and AmnioBand Membrane. Relevant results included the healing rate, number of wounds healed, and number of grafts used. Data had supported the potential of lowering the overall cost to manage a wound despite a relatively higher cost per dressing. However, discrepancy was observed in the rate of healing between several of the studies. Nonetheless, dHACM had demonstrated improvement in healing of recalcitrant diabetic foot ulcers compared to standard of care alone. These results provide grounds for more inclusive research on dHACM in the future.
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 number of people with diabetes is expected to reach 592 million in the year 2035. Diabetic foot lesions are responsible for more hospitalizations than any other complication of diabetes. The aims of this study were to examine for the first time a new biocompatible and biodegradable tridimensional collagen-based matrix, GBT013, in humans for diabetic foot ulcer wound healing and to evaluate its ease of use to better define a protocol for a future clinical trial. Seven adult patients with a diabetic foot ulcer of grade 1A to 3D (University of Texas Diabetic Wound Classification) were treated using GBT013, a new collagen-based advance dressing and were monitored in two specialized foot care units for a maximum of 9 weeks. Five of seven wounds achieved complete healing in 4 to 7 weeks. Nonhealed ulcers showed a significant reduction of the wound surface (>44%). GBT013 was well tolerated and displayed positive wound healing outcomes as a new treatment strategy of chronic foot ulcers in diabetic patients.