Palliative care aspects of wound healing in complex patients: a case report.

DECLARATION OF INTEREST: The authors have no conflicts of interest to declare.

Evidence supporting wound care end points relevant to clinical practice and patients' lives. Part 2. Literature survey.

Patients with wounds bear significant clinical, personal, and economic burdens yet complete wound healing is the only United States Food and Drug Administration (FDA) recognized primary clinical trial end point. The overall goal of this project is to work with FDA to expand the list of acceptable primary end points, recognizing that new and innovative treatments, devices, and drugs may not have complete healing as the focus. Part 1 of the project surveyed 628 wound care experts who identified and content-validated 15 end points most relevant to clinical practice and benefitting patients' lives as primary outcomes in clinical trials. Part 2 is focused on critical appraisal of the evidence in the wound care literature supporting FDA criteria to qualify these 15 end points as primary end points in clinical trials. Further research involved systematic review of the literature regarding the most promising end points. Forty volunteer, interdisciplinary, wound healing experts in fields related to the end points compiled evidence from systematic MEDLINE searches and society databases supporting the FDA criteria of reliability, clinical construct validity, capacity to detect concurrent or longitudinal change, and responder analysis. The search revealed 485 references involving over 462,000 subjects supporting FDA-required parameters for all 15 end points More than 50 references supported FDA-required parameters qualifying the following outcomes for use in clinical trials supporting interventions for FDA clearance: Pain reduction, Physical function and ambulation, Infection reduction, Time to heal, and Percent wound area reduction in 4-8 weeks. Among these, only Time to heal is currently recognized by the FDA as a primary wound outcome in clinical trials. These results suggest that wound science is already serving patients and professionals by improving these content-validated outcomes that merit regulatory consideration.

Updating on understanding and managing chronic wound.

The art of healing wounds is quite complex. It requires the patient's local condition in conjunction with their systemic condition to provide the most ideal wound environment. As wound care is expanding with advances in technology, we are facing a variety of different wound care products based on an assortment of bioengineered skin substances, growth factors, oxygen therapies, low frequency ultrasound and even low energy light. While these emerging evidence-based treatments prove to be promising in improving clinical outcomes and quality of life, it challenges providers to provide cost-effective treatment plans. The goal of this paper is to introduce a discussion regarding practical clinical application of various forms of advanced wound technologies in order to optimize the art of wound healing.

Annual Foot Exams are Associated with Reduced Incident Amputation among Older Veterans with Diabetes.

We conducted a secondary data analysis to evaluate the association between annual foot exams and incident lower extremity amputations (LEA) among older veterans with diabetes during FY2007-FY2014. Older Veterans with at least one primary care provider visit each year (N = 664,162) and at least one foot exam each year (N = 72,892) and the overlap were identified from the 5 years prior to the study period of interest (FY2002-FY2006 (N = 71,122)). After excluding incident LEA related to cancer and trauma, 71,018 veterans (mean age +/- SD, % male) were included in the final cohort, which was followed from FY2007-FY2014 to evaluate the influence of subsequent annual foot exams and incident LEA. Consistent annual foot exams were protective for incident LEA in older veterans with diabetes, adjusted OR was 0.85 (97% CI: 0.74-0.96). Results indicate that adherence to annual foot exam guidelines can reduce incident LEA in older veterans with diabetes.

Using a Post Fall Assessment Simulation to Examine Nurse Thought Processes.

The prevalence of injurious falls is high in the Veterans Health Administration (VHA) and a major patient safety issue. The VHA is embracing technology such as simulation to improve patient care. Little is known regarding nurse thought processes while undergoing a post fall assessment simulation in the VHA. This article examines the benefit of using an evidence-based post fall simulation to improve nurse assessment skills while providing opportunity for practice without harm to patients.

Long-term metformin treatment and risk of peripheral neuropathy in older Veterans.

AIM: Our objective was to assess whether increased duration of metformin therapy is associated with incident peripheral neuropathy (PN) in older Veterans with diabetes. METHODS: Using national Veterans Affairs registry data from 2002 to 2015, we examined Veterans (50 + years) with diabetes. Long-term metformin therapy was defined as prescription ≥ 500 mg/day, filled for ≥ 6 consecutive months. Metformin therapy duration was examined both as continuous and categorical measures. Incident PN was defined by medical chart review. We estimated unadjusted and adjusted (variables selecteda priori)odds ratios (OR) and 95% confidence intervals (CI) using logistic regression. RESULTS: The study included n = 210,004 individuals (mean ± SD: age: 66.2 ± 8.4 yrs, 96% male) prescribed metformin for 47.0 ± 34.0 months. Nineteen percent developed PN during follow-up. After adjusting for age, body mass index, duration of time receiving health care within the VA, smoking status, alcohol abuse, and vitamin B12 testing and treatment, the number of months of metformin treatment was associated with elevated odds for incident PN (aOR (metformin treatment - continuous) = 1.009 (95% CI = 1.009, 1.010); aOR (metformin treatment - categorical (ref: 6-<18 months): 18-<44.1 months = 1.57 (1.51-1.63), 44.1-<61 months = 2.05 (1.97-2.14), 61 + months = 2.69 (2.58-2.79), all p-values < 0.0001). CONCLUSION: Our study suggests that Veterans treated for at least 18 months with metformin are approximately 2-3 times more likely to develop PN than those treated at least six, but<18 months. Future studies are needed to determine whether the association we found may be due to a decline in vitamin B12 status following metformin initiation.

A Retrospective Review of Adverse Events Related to Diabetic Foot Ulcers.

The risk of adverse events (AEs) such as infection and amputation related to diabetic foot ulcers (DFUs) has been studied, but less is known about rate of other AEs such as falls. As part of a quality improvement project, AEs in veterans with diabetes mellitus (DM) with and without a DFU were examined. Demographic data including ICD-9 codes, AEs, and comorbidities for all patients with a diagnosis of DM and/or DFU treated between 2009 and 2014 at the James A. Haley Veterans' Hospital, Tampa, FL, were reviewed retrospectively utilizing the Corporate Data Warehouse (CDW) database. Identifiable protected health information data using patient scrambled social security numbers were collected from the CDW to allow the longitudinal data to be linked at the unique patient level. Descriptive statistics (eg, mean, standard deviation) were determined for demographics, AE, and comorbidities. Adjusted models of AE association with DM and DFU were analyzed using regression modeling via a statistical analysis system. The models were adjusted for age, race, gender, marital status, and comorbidities. Data extracted included individuals diagnosed with diabetes with a DFU (n = 3238, average age 66.0 ± 10.6 years) and diabetes without DFU (n= 41 324, average age 64.4 ± 11.5 years). Participants were mostly Caucasian in both the DFU and non-DFU cohorts (2655 [82.0%] and 32 269 [78.1%], respectively) and male (3129 [96.6%] and 39 580 [95.8%], respectively). The most common comorbidities in this population were peripheral vascular disease (PVD, 39.5%) and peripheral neuropathy (PN, 23.2%). PVD was more common in veterans with (39.5%) than without a DFU (9.2%). Compared to individuals with DM, those with DM and DFU were significantly more likely to experience an infection (OR = 9.43; 95% CI 8.54-10.4), undergo an amputation (OR = 7.40; 95% CI 6.16-8.89), or experience a fracture (OR = 3.65; 95% CI 2.59-5.15) or fall (OR = 2.26; 95% CI 1.96-2.60) (P <.01 for all variables). Although the increased risk of infection and amputation among persons with DFUs has been documented, less is known about the rate of falls and fractures. The current findings will serve as baseline data for future implementation trials to reduce DFU-associated AEs, and clinicians may want to consider expanding DFU patient education efforts to include fall risk.

Treatment of a High-Risk Diabetic Patient with Peripheral Vascular Disease and Osteomyelitis.

We report a case of calcaneal osteomyelitis that was surgically resected from a patient with diabetes and peripheral vascular disease. A 91-year-old male with history of type 2 diabetes, peripheral vascular disease, balloon angioplasty, and recent (2 months ago) stent of the superficial femoral artery presented to the emergency department with a left heel wound infection probed to bone. The patient reported having been on intravenous Zosyn for several months via an outside infectious disease provider for clinical suspicion of osteomyelitis, but noted no improvement. This report includes information regarding the clinical examination and imaging findings, which were used to assess this high-risk patient. Our patient underwent a partial calcanectomy and completed a 6-week course of intravenous antibiotics. The purpose of this case report is to illustrate limb preservation in a high-risk patient with compromised vascular supply who underwent a partial calcanectomy for treatment of calcaneal osteomyelitis. The patient underwent surgical resection of the calcaneus without complications and healed unremarkably with the ability to ambulate while wearing an ankle foot orthosis with a custom shoe. This report was authorized for publication as an educational report to contribute to generalizable knowledge and does not include any patient health information.