Condition: Chronic Wounds

Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population

     This study has been completed.      Summary: The purpose of this study was to evaluate the effectiveness and efficiency of two models of service delivery: traditional single service delivery model (home visiting) in comparison to nurse-led community clinics. The management of chronic wounds in the community is a pressing issue for home care authorities. The care of leg ulcers represents a considerable expense to the healthcare system and statistics show that the care of venous leg ulcers alone consumes 1% of the national healthcare budgets of the UK and France. A month long prevalence study in the Ottawa Carleton region (population of 750,000) revealed that 126 Community Care Access Centre Clients (CCAC-the regional healthcare authority) received more than 1500 nursing home visits. During the course of a year this represents more than $600,000 in home nursing visits for this condition in just one Ontario region. While there is evidence that supports effective wound management, this is not necessarily what patients receive. Individuals referred to home care for leg ulcer management were randomized to nurse home visits (usual care) or nurse-run community clinics (intervention). The primary outcome measure was the proportion of limbs healed by 3 months. Secondary outcome measures were the time to complete healing, ulcer size, ulcer recurrence, function, pain, quality of life, and client and provider satisfaction. Some of the research questions were, ‘what are the health outcomes (healing, function, pain, and quality of life) for two models of care (nurse-run neighborhood clinics vs. home care) for the population with leg ulcers?’ and ‘what are the barriers and supports to implementing neighborhood leg ulcer clinics?’ Research from other countries suggest that reorganization of services including nurse-run clinic care closest to home, evidence-based protocols, and enhanced linkages with secondary and tertiary services may result in improvements in healing rates and reductions in expenditures. These international studies provide hope in that the reorganization of care within the Canadian context; healthcare providers can deliver community services for improved outcomes.      Location: Victorian Order of Nurses, Ottawa-Carleton, Ottawa, Ontario, Canada      Sponsor(s): Queen’s University; The Ottawa Hospital; University of Ottawa      Principle investigator: Margaret B. Harrison, RN, PhD, Ottawa, Ontario, Canada      ClinicalTrials.gov identifier: NCT00656383

UT-15C SR in the Treatment of Critical Limb Ischemia

     This study is currently recruiting participants.      Summary: This study will evaluate UT-15C sustained release tablets in subjects experiencing ischemic lower limb rest pain related to advanced peripheral arterial disease. Rest pain is one of the primary management issues of severe arterial occlusive disease and may lead to amputation when the pain becomes intolerable and unresponsive to narcotic analgesia. Rest pain also impacts the quality of sleep and mobility with frequent interruptions in sleep and decreased mobility. Treprostinil sodium (Remodulin®) has been observed in several small open-label studies and has proved to be a safe and a highly effective agent for ischemic rest pain when given by subcutaneous or intravenous delivery. These forms of administration have patient convenience limitations, including the need for an infusion device and associated pain at the site of infusion with subcutaneous delivery. UT-15C may allow patients suffering from chronic critical limb ischemia (CLI) to benefit from the simplicity of an oral dosage form. The study will take place over the course of 8 weeks and is a two center, open-label study, specifically assessing the tolerability, safety, and efficacy of oral UT-15C sustained release tablets in subjects with CLI and ischemic lower limb rest pain, with or without an ischemic wound present. Conventional therapy should be continued without changes over the course of the study for all subjects. In Group 1, the first 10 subjects to enroll in the study will be assigned to receive an initial dose of 1mg. The dose will be titrated upward every 7 days depending on tolerability to a maximum dose of 4mg/day. The last 10 subjects to enroll in the study in Group 2 will be assigned to receive an initial dose of 1mg. The dose will be titrated upward every 7 days depending on tolerability to a maximum dose of 8mg/day. The age range for eligible participants is 45–85 years of age and both men and women can participate.      Location: Southern Arizona Vascular Institute, Tucson, Arizona; Southern Illinois University, Carbondale, Illinois      Sponsor(s): Southern Arizona Vascular Institute; Southern Illinois University      Principle investigator: Colleen Johnson, MD, Southern Illinois University; Scott S. Berman, MD, Southern Arizona Vascular Institute      ClinicalTrials.gov identifier: NCT00445159

Study to Evaluate the Safety and Performance of the Xpert™ Stent in Treating Below-the-Knee Lesions in Patients Undergoing Percutaneous Intervention for Chronic Critical Limb Ischemia (XCELL)

     This study is currently recruiting participants.      Summary: The purpose of this study is to evaluate the safety and performance of the Xpert™ self-expanding stent in infrapopliteal lesions as part of an overall treatment strategy in patients undergoing percutaneous intervention for the treatment of documented chronic critical limb ischemia (CLI). Peripheral arterial disease (PAD) of the lower extremities affects roughly 25 million Americans annually. The diabetic population is particularly prone to the most severe critical problems associated with PAD and the amputation rate amongst such patients is elevated five-fold. It has been shown that patients who undergo amputation for PAD/CLI have a much higher mortality rate in the months that follow. Despite medical advances in the fields of pharmacology and wound care, the vast majority of patients who present with CLI will ultimately require amputation in the absence of improved blood flow. Recently, much attention has been directed towards less invasive endovascular solutions for treating patients with CLI. This study will evaluate approximately 140 subjects with Rutherford Class IV-VI PAD in a multi-center study in order to accurately estimate limb salvage rates for this treatment. Participant age range is 18 to 89 years of age for participants and both men and women can participate.      Location: VIVA Physicians, Inc., San Jose, California      Sponsor(s): VIVA Physicians, Inc.; Prairie Education and Research Cooperative      Principle investigator: James D. Joye, DO, VIVA Physicians, Inc.      ClinicalTrials.gov identifier: NCT00515346 The information contained in this update was summarized from www.clinicaltrials.gov. Copyright © US National Library of Medicine.