A prospective, double-blind, randomized, controlled clinical trial comparing standard wound care with adjunctive hyperbaric oxygen therapy (HBOT) to standard wound care only for the treatment of chronic, non-healing ulcers of the lower limb in patients with diabetes mellitus: a study protocol

<p>Abstract</p> <p>Background</p> <p>It has been suggested that the use of adjunctive hyperbaric oxygen therapy improves the healing of diabetic foot ulcers, and decreases the risk of lower extremity amputations. A limited number of studies have used a double blind approach to evaluate the efficacy of hyperbaric oxygen therapy in the treatment of diabetic ulcers. The primary aim of this study is to assess the efficacy of hyperbaric oxygen therapy plus standard wound care compared with standard wound care alone in preventing the need for major amputation in patients with diabetes mellitus and chronic ulcers of the lower limb.</p> <p>Methods/Design</p> <p>One hundred and eighteen (59 patients per arm) patients with non-healing diabetic ulcers of the lower limb, referred to the Judy Dan Research and Treatment Centre are being recruited if they are at least 18 years of age, have either Type 1 or 2 diabetes with a Wagner grading of foot lesions 2, 3 or 4 on lower limb not healing for at least 4 weeks. Patients receive hyperbaric oxygen therapy every day for 6 weeks during the treatment phase and are provided ongoing wound care and weekly assessments. Patients are required to return to the study centre every week for an additional 6 weeks of follow-up for wound evaluation and management. The primary outcome is freedom from having, or meeting the criteria for, a major amputation (below knee amputation, or metatarsal level) up to 12 weeks after randomization. The decision to amputate is made by a vascular surgeon. Other outcomes include wound healing, effectiveness, safety, healthcare resource utilization, quality of life, and cost-effectiveness. The study will run for a total of about 3 years.</p> <p>Discussion</p> <p>The results of this study will provide detailed information on the efficacy of hyperbaric oxygen therapy for the treatment of non-healing ulcers of the lower limb. This will be the first double-blind randomized controlled trial for this health technology which evaluates the efficacy of hyperbaric oxygen therapy in prevention of amputations in diabetic patients.</p> <p>Trial registration</p> <p>ClinicalTrials.gov Identifier: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00621608">NCT00621608</a></p

Crossover of Work–Life Balance Perceptions: Does Authentic Leadership Matter?

This research contributes to an improved understanding of authentic leadership at the work–life interface. We build on conservation of resources theory to develop a leader–follower crossover model of the impact of authentic leadership on followers’ job satisfaction through leaders’ and followers’ work–life balance. The model integrates authentic leadership and crossover literatures to suggest that followers perceive authentic leaders to better balance their professional and private lives, which in turn enables followers to achieve a positive work–life balance, and ultimately makes them more satisfied in their jobs. Data from working adults collected in a correlational field study (N = 121) and an experimental study (N = 154) generally supported indirect effects linking authentic leadership to job satisfaction through work–life balance perceptions. However, both studies highlighted the relevance of followers’ own work–life balance as a mediator more so than the sequence of leaders’ and followers’ work–life balance. We discuss theoretical implications of these findings from a conservation of resources perspective, and emphasize how authentic leadership represents an organizational resource at the work–life interface. We also suggest practical implications of developing authentic leadership in organizations to promote employees’ well-being as well as avenues for future research