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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.