Piloting an automated clinical trial eligibility surveillance and provider alert system based on artificial intelligence and standard data models.

BACKGROUND: To advance new therapies into clinical care, clinical trials must recruit enough participants. Yet, many trials fail to do so, leading to delays, early trial termination, and wasted resources. Under-enrolling trials make it impossible to draw conclusions about the efficacy of new therapies. An oft-cited reason for insufficient enrollment is lack of study team and provider awareness about patient eligibility. Automating clinical trial eligibility surveillance and study team and provider notification could offer a solution. METHODS: To address this need for an automated solution, we conducted an observational pilot study of our TAES (TriAl Eligibility Surveillance) system. We tested the hypothesis that an automated system based on natural language processing and machine learning algorithms could detect patients eligible for specific clinical trials by linking the information extracted from trial descriptions to the corresponding clinical information in the electronic health record (EHR). To evaluate the TAES information extraction and matching prototype (i.e., TAES prototype), we selected five open cardiovascular and cancer trials at the Medical University of South Carolina and created a new reference standard of 21,974 clinical text notes from a random selection of 400 patients (including at least 100 enrolled in the selected trials), with a small subset of 20 notes annotated in detail. We also developed a simple web interface for a new database that stores all trial eligibility criteria, corresponding clinical information, and trial-patient match characteristics using the Observational Medical Outcomes Partnership (OMOP) common data model. Finally, we investigated options for integrating an automated clinical trial eligibility system into the EHR and for notifying health care providers promptly of potential patient eligibility without interrupting their clinical workflow. RESULTS: Although the rapidly implemented TAES prototype achieved only moderate accuracy (recall up to 0.778; precision up to 1.000), it enabled us to assess options for integrating an automated system successfully into the clinical workflow at a healthcare system. CONCLUSIONS: Once optimized, the TAES system could exponentially enhance identification of patients potentially eligible for clinical trials, while simultaneously decreasing the burden on research teams of manual EHR review. Through timely notifications, it could also raise physician awareness of patient eligibility for clinical trials.

Efficacy of a Self-managed Cooling Intervention for Pain and Physical Activity in Individuals With Recently Healed Chronic Venous Leg and Diabetic Foot Ulcers: A Randomized Controlled Trial.

PURPOSE: This aim of this study was to evaluate the clinical efficacy of a self-managed cooling intervention in individuals with recently healed venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs) on pain reduction and physical activity improvement. DESIGN: A 6-month longitudinal randomized controlled trial. SUBJECTS AND SETTING: The sample comprised 140 individuals with previously healed VLU and DFU who received care in 3 outpatient wound centers in the Southeastern region of the United States. Participants were randomized to the MUSTCOOL or a placebo cooling patch intervention. METHODS: The cooling and placebo interventions comprised cooling or cotton-filled patch application to recently healed skin for 30 minutes, 3 times weekly plus standard of care including compression and leg elevation (participants with VLU) or therapeutic footwear and hygiene (participants with DFU) over a 6-month period. Pain severity and intensity were measured with the Brief Pain Inventory and physical activity with the International Physical Activity Questionnaire, which assessed metabolic equivalent of tasks (METs) in minutes per week. Minutes in walking time per week were assessed with an accelerometer. Data were descriptively analyzed for difference changes in scores from baseline to 6 months post-intervention. RESULTS: Data were analyzed for 81 participants randomized to cooling and placebo groups (VLUs, n = 26/29) and DFU (n = 12/16). Slight reductions in VLU pain severity (-0.5, -0.2) and interference (-0.4, -0.5) and minimal reductions in DFU pain severity (0, -0.1) and interference (0.4/0.1) were achieved. However, pain scores were low to moderate at baseline (mean 4, 0-10 with 10 worst pain possible) in both groups. For physical activity, the MET values showed low physical activity in both groups at baseline with slight improvements noted in VLU cooling and placebo groups (73/799) and DFU (1921/225), respectively. Walking time for the VLU groups improved by 1420/2523 minutes; the DFU groups improved 135/157 minutes, respectively. Findings for outcomes were not statistically significant within or between groups. CONCLUSIONS: Application of the cooling pack compared to placebo was minimally efficacious in reducing posthealing pain and improving function in this posthealed ulcer population. However for pain, scores were initially low; thus outcomes on pain, while lower, were marginal. TRIAL REGISTRATION: The study was prospectively registered with ClinicalTrials.gov on December 10, 2015 (Identifier: NCT02626156), https://clinicaltrials.gov/ct2/show/NCT02626156 .

2021 Guideline for Management of Patients With Lower-Extremity Wounds Due to Diabetes Mellitus and/or Neuropathic Disease: An Executive Summary.

This article provides an executive summary of the Wound, Ostomy, and Continence Nurses Society's (WOCN) "2021 Guideline for Management of Patients With Lower-Extremity wounds Due to Diabetes Mellitus and/or Neuropathic Disease." This executive summary presents an overview of the systematic process used to update and develop the guideline and recommendations from the guideline for screening and diagnosis, assessment, and management and education of patients with lower-extremity wounds due to diabetes mellitus and/or neuropathic disease. In addition, the executive summary provides suggestions for implementing recommendations from the guideline. The guideline is a resource for WOC nurse specialists and other nurses and health care professionals who work with adults who have/or are at risk for lower-extremity wounds due to diabetes mellitus/neuropathic disease. The complete guideline includes the evidence and references supporting the recommendations, and it is available in print and electronically from the Wound, Ostomy, and Continence Nurses Society, 1120 Rt 73, Suite 200, Mount Laurel, New Jersey, 08054; Web site: www.wocn.org.

An observational study protocol to explore loneliness and systemic inflammation in an older adult population with chronic venous leg ulcers.

BACKGROUND: Chronic venous leg ulcers (CVLUs) are the most common type of lower extremity wound. Even when treated with evidenced-based care, 30-50% of CVLUs fail to heal. A specific gap exists about the association between psychosocial stressors, particularly loneliness, and biomarkers of inflammation and immunity. Loneliness is highly prevalent in persons with CVLUs, has damaging effects on health, and contributes to the development of multiple chronic conditions, promotes aberrant inflammation, and diminishes healing. However, the confluence of loneliness, inflammation and the wound healing trajectory has not been elucidated; specifically whether loneliness substantially mediates systemic inflammation and alters healing over time. This study seeks to address whether there is a specific biomarker profile associated with loneliness, CVLUs, and wound healing that is different from non-lonely persons with CVLUs. METHODS: An observational prospective study will identify, characterize and explore associations among psychosocial stressors, symptoms and biomarkers between 2 CVLU groups, with loneliness+ (n = 28) and without loneliness- (n = 28) during 4 weeks of wound treatment, measured at 3 time points. We will examine psychosocial stressors and symptoms using psychometrically-sound measures include PROMIS® and other questionnaires for loneliness, social isolation, depression, anxiety, stigma, sleep, fatigue, pain, quality of life, cognition, and function. Demographics data including health history, sex, age, wound type and size, wound age, and treatment will be recorded from the electronic health record. We will characterize a biomarker panel of inflammatory genes including chemotaxic and growth factors, vascular damage, and immune regulators that express in response to loneliness to loneliness and CVLUs using well-established RNA sequence and PCR methods for whole blood samples. In an exploratory aim we will explore whether age and sex/psychological stressors and symptoms indicate potential moderation/mediation of the effect of loneliness on the biomarker profile over the study period. DISCUSSION: This study will provide insight into the influence of psychosocial stressors, symptoms, and biological mechanisms on wound healing, towards advancing a future healing prediction model and interventions to address these stressors and symptoms experienced by persons with CVLUs.

Cooling Intervention (MUSTCOOL) for Prevention of Lower Extremity Ulcer Recurrence: A Randomized Controlled Trial.

PURPOSE: The purpose of this study was to test our MUSTCOOL cooling patch intervention on the incidence of venous leg (VLU) and diabetic foot ulcer (DFU) recurrence over a previously healed wound. DESIGN: A 6-month randomized controlled trial. SUBJECTS AND SETTING: The target population was individuals with previously healed ulcers receiving care in outpatient wound centers in the Southeastern region of the United States. The sample comprised 140 individuals with recently healed ulcers; their average age was 62.4 years (SD = 12 years); 86 (61.4%) were male; and 47 (33.6%) were Black or African American. METHODS: Participants were randomized to the MUSTCOOL or placebo patch. Both groups received instructions to apply the patch 3 times per week, and engage in standard of care including compression and leg elevation (VLU) or therapeutic footwear and hygiene (DFU). Demographic data were collected at baseline, and incidence measures taken at 1, 3, and 6 months. We also studied whether new ulcers developed on the adjacent leg or foot. Data were reported in frequencies/percentages. RESULTS: One hundred seventeen participants (84%) were analyzed who completed 6 months of study participation. Thirteen percent (9/69) and 17% (12/69) developed a recurrent or new VLU, respectively; 29% (14/48) and 13% (6/48) developed a recurrent or new DFU, respectively. One person in the DFU group developed both a recurrent and new ulcer. For 9 recurrent VLUs, 6 (66.7%) recurred in the MUSTCOOL group and 3 (33.3%) receiving the placebo. Of the 15 recurrent DFUs (includes individual who developed both a recurrent and new ulcer), 10 (66.7%) recurred in the MUSTCOOL group and 5 (33.3%) receiving the placebo. CONCLUSIONS: While the incidence of ulcer recurrent was slightly higher in the MUSTCOOL group, this finding was not considered clinically relevant. Overall ulcer recurrence during the 6-month study period was lower than reports in the literature, the time frame in which recurrence rates are highest. TRIAL REGISTRATION: The study was prospectively registered with ClinicalTrials.gov on December 10, 2015 (Identifier: NCT02626156)-https://clinicaltrials.gov/ct2/show/NCT02626156.

Prevention of Failure to Rescue in Obstetric Patients: A Realist Review.

BACKGROUND: At least 40% of maternal deaths are attributable to failure to rescue (FTR) events. Nurses are positioned to prevent FTR events, but there is minimal understanding of systems-level factors affecting obstetric nurses when patients require rescue. AIMS: To identify the nurse-specific contexts, mechanisms, and outcomes underlying obstetric FTR and the interventions designed to prevent these events. METHODS: A realist review was conducted to meet the aims. This review included literature from 1999 to 2020 to understand the systems-level factors affecting obstetric nurses during FTR events using a human factors framework designed by the Systems Engineering Initiative for Patient Safety. RESULTS: Existing interventions addressed the prevention of maternal death through education of clinicians, improved protocols for care and maternal transfer, and an emphasis on communication and teamwork. LINKING EVIDENCE TO ACTION: Few researchers addressed task overload or connected employee and organizational outcomes with patient outcomes, and the physical environment was minimally considered. Future research is needed to understand how systems-level factors affect nurses during FTR events.

FOOTFIT Physical Activity mHealth Intervention for Minimally Ambulatory Individuals With Venous Leg Ulcers: A Randomized Controlled Trial.

PURPOSE: The purpose of this study was to investigate the use of an mHealth application (app), self-management physical activity intervention FOOTFIT with an added patient-provider connectivity feature (FOOTFIT+), that was designed to strengthen the lower extremities of minimally ambulatory individuals with venous leg ulcers (VLUs). DESIGN: Randomized controlled trial. SUBJECTS AND SETTING: Twenty-four adults 18 years and older with VLUs being treated in 2 wound clinics in the Southeastern United States participated in this study. METHODS: Preliminary estimates and 95% confidence intervals for the medians of short-term functional impacts on foot function, strength, ankle range of motion, walking capacity, depression, and physical functioning were obtained pre- and postassessment after the 6-week intervention trial. RESULTS: There were negligible changes in either group for foot function. It is noted that both groups experienced substantial foot and ankle impairment at baseline. The greatest improvement in range of motion was noted in the FOOTFIT group for dorsiflexion of the right ankle (4.6 ± 5.22 lb/in over baseline) whereas strength decreased in both ankles for dorsiflexion and plantar flexion in the FOOTFIT+ group. No improvements were noted in walking distance or physical health for FOOTFIT (slight decrease -2.9 ± 5.6) and FOOTFIT+ (slight increase 3.0 ± 6.6) during the 6-week study period. CONCLUSIONS: In a minimally ambulatory population with VLUs, our mHealth FOOTFIT intervention composed of progressive exercise "boosts" demonstrated minimal short-term effects. We recommend engagement with the app for a longer period to determine longer-term outcomes of lower extremity function.

2019 Guideline for Management of Wounds in Patients With Lower-Extremity Venous Disease (LEVD): An Executive Summary.

This article provides an executive summary of the 2019 Guideline for Management of Wounds in Patients with Lower-Extremity Venous Disease (LEVD) published by the Wound, Ostomy and Continence Nurses Society (WOCN). The executive summary presents an overview of the systematic process used to update and develop the guideline. It also lists the specific recommendations from the guideline for assessment, prevention, and management of LEVD and venous leg ulcers (VLUs). In addition, the guideline includes a new section regarding implementation of clinical practice guidelines. The LEVD guideline is a resource for WOC nurse specialists and other nurses, physicians, therapists, and health care professionals who work with adults who have or who are at risk for VLU.

The Use of Technology to Support Precision Health in Nursing Science.

PURPOSE: This article outlines how current nursing research can utilize technology to advance symptom and self-management science for precision health and provides a roadmap for the development and use of technologies designed for this purpose. APPROACH: At the 2018 annual conference of the National Institute of Nursing Research (NINR) Research Centers, nursing and interdisciplinary scientists discussed the use of technology to support precision health in nursing research projects and programs of study. Key themes derived from the presentations and discussion were summarized to create a proposed roadmap for advancement of technologies to support health and well-being. CONCLUSIONS: Technology to support precision health must be centered on the user and designed to be desirable, feasible, and viable. The proposed roadmap is composed of five iterative steps for the development, testing, and implementation of technology-based/enhanced self-management interventions. These steps are (a) contextual inquiry, focused on the relationships among humans, and the tools and equipment used in day-to-day life; (b) value specification, translating end-user values into end-user requirements; (c) design, verifying that the technology/device can be created and developing the prototype(s); (d) operationalization, testing the intervention in a real-world setting; and (e) summative evaluation, collecting and analyzing viability metrics, including process data, to evaluate whether the technology and the intervention have the desired effect. CLINICAL RELEVANCE: Interventions using technology are increasingly popular in precision health. Use of a standard multistep process for the development and testing of technology is essential.

Nurses' perceptions of high-alert medication administration safety: A qualitative descriptive study.

AIMS: The aim of this study was to determine nurses' perceptions of supports and barriers to high-alert medication (HAM) administration safety. DESIGN: A qualitative descriptive design was used. METHODS: Eighteen acute care nurses were interviewed about HAM administration practices. Registered nurses (RNs) working with acutely ill adults in two hospitals participated in one-on-one interviews from July-September, 2017. Content analysis was conducted for data analysis. RESULTS: Three themes contributed to HAM administration safety: Organizational Culture of Safety, Collaboration, and RN Competence and Engagement. Error factors included distractions, workload and acuity. Work arounds bypassing bar code scanning and independent double check procedures were common. Findings highlighted the importance of intra- and interprofessional collaboration, nurse engagement and incorporating the patient in HAM safety. CONCLUSIONS: Current HAM safety strategies are not consistently used. An organizational culture that supports collaboration, education on safe HAM practices, pragmatic HAM policies and enhanced technology are recommended to prevent HAM errors. IMPACT: Hospitals incorporating these findings could reduce HAM errors. Research on nurse engagement, intra- and interprofessional collaboration and inclusion of patients in HAM safety strategies is needed.

An approach to revising mHealth interventions for children and families: A case example in sickle cell disease.

Frameworks for developing mHealth interventions that are informed by the end-user and improve accessibility are necessary to ensure interventions meet the needs of the intended population and advance the science of health behavior change. The approach described in this paper addresses a gap in the mHealth development literature by describing a step-by-step method for evaluating and revising the mHealth interventions for health behavior change in child-parent dyads. Furthermore, this approach introduces the Website Analysis and MeasureMent Inventory framework as an initial coding structure for analyzing qualitative data to gauge appeal and enhance engagement of intervention for end-users. This method uses specific considerations for child-parent dyads and details an example in the development and refinement of a mobile application for self-management in children with sickle cell disease. This approach is translatable to populations of children with other chronic conditions and to other health behaviors.

Precision health: Advancing symptom and self-management science.

BACKGROUND: Precision health considers individual lifestyle, genetics, behaviors, and environment context and facilitates interventions aimed at helping individuals achieve well-being and optimal health. PURPOSE: To present the Nursing Science Precision Health (NSPH) Model and describe the integration of precision health concepts within the domains of symptom and self-management science as reflected in the National Institute of Nursing Research P30 Centers of Excellence and P20 Exploratory Centers. METHODS: Center members developed the NSPH Model and the manuscript based on presentations and discussions at the annual NINR Center Directors Meeting and in follow-up telephone meetings. DISCUSSION: The NSPH Model comprises four precision components (measurement; characterization of phenotype including lifestyle and environment; characterization of genotype and other biomarkers; and intervention target discovery, design, and delivery) that are underpinned by an information and data science infrastructure. CONCLUSION: Nurse scientist leadership is necessary to realize the vision of precision health as reflected in the NSPH Model.

Onychomycosis: Diagnosis, Treatment, and Prevention.

Toenail disorders account for the majority of foot complaints for which adults seek medical care. Onychomycosis, a fungal nail infection, is the most prevalent. Dermatophytes are responsible for the majority of nail infections and cause varying degrees of nail deformities. While several treatment strategies are available, no one approach (topical, systemic, or mechanical) is highly curative. This article reviews causes, diagnosis, and treatment options for onychomycosis and provides patient education tips to prevent and limit the spread of the disease.

Nursing Theory, Terminology, and Big Data: Data-Driven Discovery of Novel Patterns in Archival Randomized Clinical Trial Data.

BACKGROUND: The growth and diversification of nursing theory, nursing terminology, and nursing data enable a convergence of theory- and data-driven discovery in the era of big data research. Existing datasets can be viewed through theoretical and terminology perspectives using visualization techniques in order to reveal new patterns and generate hypotheses. The Omaha System is a standardized terminology and metamodel that makes explicit the theoretical perspective of the nursing discipline and enables terminology-theory testing research. OBJECTIVE: The purpose of this paper is to illustrate the approach by exploring a large research dataset consisting of 95 variables (demographics, temperature measures, anthropometrics, and standardized instruments measuring quality of life and self-efficacy) from a theory-based perspective using the Omaha System. Aims were to (a) examine the Omaha System dataset to understand the sample at baseline relative to Omaha System problem terms and outcome measures, (b) examine relationships within the normalized Omaha System dataset at baseline in predicting adherence, and (c) examine relationships within the normalized Omaha System dataset at baseline in predicting incident venous ulcer. METHODS: Variables from a randomized clinical trial of a cryotherapy intervention for the prevention of venous ulcers were mapped onto Omaha System terms and measures to derive a theoretical framework for the terminology-theory testing study. The original dataset was recoded using the mapping to create an Omaha System dataset, which was then examined using visualization to generate hypotheses. The hypotheses were tested using standard inferential statistics. Logistic regression was used to predict adherence and incident venous ulcer. RESULTS: Findings revealed novel patterns in the psychosocial characteristics of the sample that were discovered to be drivers of both adherence (Mental health Behavior: OR = 1.28, 95% CI [1.02, 1.60]; AUC = .56) and incident venous ulcer (Mental health Behavior: OR = 0.65, 95% CI [0.45, 0.93]; Neuro-musculo-skeletal function Status: OR = 0.69, 95% CI [0.47, 1.00]; male: OR = 3.08, 95% CI [1.15, 8.24]; not married: OR = 2.70, 95% CI [1.00, 7.26]; AUC = .76). DISCUSSION: The Omaha System was employed as ontology, nursing theory, and terminology to bridge data and theory and may be considered a data-driven theorizing methodology. Novel findings suggest a relationship between psychosocial factors and incident venous ulcer outcomes. There is potential to employ this method in further research, which is needed to generate and test hypotheses from other datasets to extend scientific investigations from existing data.

Motivators and Barriers to Walking in Older Adults With Peripheral Artery Disease.

The purpose of the current review is to provide, within the context of social cognitive theory, a current description of behavioral, personal, and environmental factors that motivate or prevent an individual with peripheral artery disease (PAD) from participating in activity. A comprehensive review to explore motivators and barriers to walking in older adults with PAD was performed to help guide development of interventions to increase activity. Several databases were used for the literature review, with inclusion criteria being all study designs with samples of older adults with PAD. From the initial yield of 22 abstracts, and additional hand search, eight publications were used for this review. Social cognitive theory provided a context for understanding barriers and motivators to walking experienced by older adults with PAD. Nurses may contribute to walking self-efficacy with support and motivation. [Journal of Gerontological Nursing, 44(1), 43-50.].

Symptoms Associated With Chronic Venous Disease in Response to a Cooling Treatment Compared to Placebo: A Randomized Clinical Trial.

PURPOSE: The purpose of this study was to examine the efficacy of a self-administered cooling treatment on clinically meaningful differences (CMDs) in symptom changes in patients with chronic venous disease. DESIGN: Blinded, prospective, randomized controlled trial. SUBJECTS AND SETTING: Two hundred seventy-six community-dwelling adults 21 years and older with skin changes and/or a healed venous leg ulcer (Clinical-Etiologic-Anatomic-Pathologic [CEAP] 4 and 5 classification) completed the 6-month active treatment period. METHODS: Participants were recruited from wound and medicine clinics and from the general population through referrals or advertisements. Participants were randomly allocated to a sham control cuff or interventional cooling cuff group. Demographic and symptom-specific data were collected at baseline and at months 1, 3, and 6 with the 11-item symptom Venous Insufficiency Epidemiological and Economic Study Quality of Life/Symptom (VEINES QOL/Sym) questionnaire subscale for heavy legs, aching legs, swelling, night cramps, heating or burning sensation, restless legs, throbbing, itching, tingling sensation (pins and needles), pain, and irritability. Participants in the intervention group received a cooling gel cuff and those in the control group received a cotton-filled cuff to be place around the most affected lower leg during leg elevation. Both groups received standard of care for their chronic venous disease with compression wraps and skin hygiene. Dosing consisted of daily 30-minute treatment for 1 month, twice weekly for 2 months, and then thrice weekly for 3 months. To analyze and compare data, a mixed percentage clinically meaningful percentage change was used to assess CMDs in symptoms between groups for treatment modality, sex, and age group. RESULTS: All symptoms showed improvement, with throbbing, aching, itching, and pain demonstrating the greatest CMD in response to the cooling treatment. For throbbing and aching, similar improvements were noted in response to cooling; 50% in the cooling group showed improvement, whereas 60% in both groups responded favorably to pain. More than 50% of females and males reported improvements in throbbing; both males and females reported 60% improvements in pain in response to cooling. In contrast, far fewer females reported worsening of aching in the treatment group as compared to male participants (8% vs 20%). Age differences were noted for throbbing in the younger group (<65 years of age); older individuals 65 years or older saw CMDs in aching in response to cooling. CONCLUSIONS: Of the 11 symptoms, aching, throbbing, itching, and pain had greater clinically meaningful improvements in response to a cooling cuff applied to lower leg skin affected by chronic venous disease. These CMDs inform evidence-based practice by enhancing clinician understanding of which symptoms, physical, physiological, and behavioral outcomes, respond to treatment change in a meaningful way for the patient.

Does cryotherapy improve skin circulation compared with compression and elevation in preventing venous leg ulcers?

This trial compared skin blood flow, temperature and incidence of venous leg ulcers in patients with chronic venous disease using compression wraps and elevation pillows. Patients with CEAP C4 skin damage and C5 history of ulcers were randomly assigned to a cryotherapy intervention (n = 138) or placebo cuff control (n = 138) applied to the lower legs over 9 months. The time the ulcers healed prior to enrollment in the study for the cryotherapy group ranged from 1 to 2218 days (n = 8, median = 32 days); for the control group, the range was 24 to 489 days (n = 6, median = 390 days). There were no statistically significant blood flow changes measured in perfusion units with a laser Doppler flowmetre within or between the groups; mean difference between the groups was 0·62, P = 0·619. No differences were noted in skin temperature measured with an infrared thermometer within and between the groups; mean difference between the groups was -0·17°C, P = 0·540. Cryotherapy did not improve skin blood flow or temperature and did not show efficacy in preventing ulcers. However, at least 30% of intervention and 50% of control participants were anticipated to develop an ulcer during the study; only ∼7% occurred. These findings suggest that strict adherence to standard of care decreases the incidence of leg ulcers and remains a best practice for leg ulcer prevention.

Impact of daily cooling treatment on skin inflammation in patients with chronic venous disease.

People with chronic venous disease are at high risk for developing venous leg ulcers. Inflammation is posited as a pathological factor for this chronic condition as evidenced by persistently elevated skin temperature. As part of a larger trial to test the effects of a cooling regimen on leg ulcer prevention, the objective of this preliminary study was to evaluate the first 30 days of intense daily cooling. Compared to a placebo control cuff, a gel cuff applied to the most severely affected lower leg skin for 30 min daily showed no statistically significant differences between temperatures taken in the home at baseline compared to those measured at the 1 month follow up visit. There were also no differences in temperatures noted between the two groups, although the temperatures in the treatment group were lower 30 min after treatment, an indication of adherence. There was no discernable decrease or increase in temperature at a given time point during the 30 day treatment period compared to the control group. It may be better to have patients monitor skin temperature on a daily basis and then apply the cuff as necessary, rather than requiring daily cooling based on baseline measurement. This "prn" approach may provide a sufficient cooling milieu to prevent escalation of inflammation and thwart ulcer occurrence or recurrence. Clinical trials registration #NCT01509599.