Early endovenous ablation of superficial venous reflux resulted in faster healing of venous leg ulcers and more time free from ulcers than deferred endovenous ablation. (Funded by the National Institute for Health Research Health Technology Assessment Program; EVRA Current Controlled Trials number, ISRCTN02335796 .).
OBJECTIVETopical oxygen has been used for the treatment of chronic wounds for more than 50 years. Its effectiveness remains disputed due to the limited number of robust high-quality investigations. The aim of this study was to assess the efficacy of multimodality cyclical pressure Topical Wound Oxygen (TWO2) home care therapy in healing refractory diabetic foot ulcers (DFUs) that had failed to heal with standard of care (SOC) alone.
RESEARCH DESIGN AND METHODSPatients with diabetes and chronic DFUs were randomized (double-blind) to either active TWO2 therapy or sham control therapydboth in addition to optimal SOC. The primary outcome was the percentage of ulcers in each group achieving 100% healing at 12 weeks. A group sequential design was used for the study with three predetermined analyses and hard stopping rules once 73, 146, and ultimately 220 patients completed the 12-week treatment phase.
RESULTSAt the first analysis point, the active TWO2 arm was found to be superior to the sham arm, with a closure rate of 41.7% compared with 13.5%. This difference in outcome produced an odds ratio (OR) of 4.57 (97.8% CI 1.19, 17.57), P 5 0.010. After adjustment for University of Texas Classification (UTC) ulcer grade, the OR increased to 6.00 (97.8% CI 1.44, 24.93), P 5 0.004. Cox proportional hazards modeling, also after adjustment for UTC grade, demonstrated >4.5 times the likelihood to heal DFUs over 12 weeks compared with the sham arm with a hazard ratio of 4.66 (97.8% CI 1.36, 15.98), P 5 0.004. At 12 months postenrollment, 56% of active arm ulcers were closed compared with 27% of the sham arm ulcers (P 5 0.013).
CONCLUSIONSThis sham-controlled, double-blind randomized controlled trial demonstrates that, at both 12 weeks and 12 months, adjunctive cyclical pressurized TWO2 therapy was superior in healing chronic DFUs compared with optimal SOC alone.Clinical trial reg. no. NCT02326337, clinicaltrials .gov. This article contains Supplementary Data online at https://care.diabetesjournals.org/lookup/suppl/
The evolution of atherosclerosis can be studied before development of symptomafic plaque by evaluating morphologic changes of the intima-media (I-M) complex, seen on high-resolution ultrasonography of the arterial wall. These qualitative changes require l~xge alterations in vessel wall appearance to recognize progression of atherosclerosis. It has been suggested that measurement of the thickness of the I-M complex may be a quantitative and more sensitive method of assessing these early atherosclerotic changes. ~fethods: High-resolution ultrasonography has been used to measure the thickness of the I-M complex in 140 symptom-free subjects. Results: The mean thickness of the I-M complex of the common carotid arteries was linearly related to the age (r-0.77;p< 0.001), pack-years of smoking (r = 0.39;p < 0.05), the systolic blood pressure (r = 0.51, p < 0.01), and to the arterial ultrasound score (r = 0.85). The arterial ultrasound score has previously been shown to correlate with the presence of asymptomatic myocardial ischemia and with the development of cardiovascular symptoms. The mean thickness of the I-M complex in subjects without plaque (in the common carotid or common femoral artery bifurcations) was significantly thinner than in subjects with plaque (p < 0.001). Gmclusion: The thickness of the I-M complex of the common carotid arteries is a measure of the risk for the development of cardiovascular symptoms in symptom-free individuals.
This study was supported by a research grant from the Clarivein device manufacturer, Vascular Insights and an educational research grant from the Graham-Dixon Charitable Trust. Vascular Insights provided funding for Clarivein devices, patient follow-up and duplex ultrasonography. Case funding was not used in this study. All trial particulars (design, data collection, analysis, discussion and data access) were performed independently of the funding bodies and the trial's research sponsor was Imperial College London.
Background
Patients undergoing prolonged pelvic surgery may develop compartment syndrome of one or both lower limbs in the absence of direct trauma or pre‐existing vascular disease (well leg compartment syndrome). This condition may have devastating consequences for postoperative recovery, including loss of life or limb, and irreversible disability.
Methods
These guidelines represent the collaboration of a multidisciplinary group of colorectal, vascular and orthopaedic surgeons, acting on behalf of their specialty associations in the UK and Ireland. A systematic analysis of the available peer‐reviewed literature was undertaken to provide an evidence base from which these guidelines were developed.
Results
These guidelines encompass the risk factors (both patient‐ and procedure‐related), diagnosis and management of the condition. Key recommendations for the adoption of perioperative strategies to facilitate prevention and effective treatment of well leg compartment syndrome are presented.
Conclusion
All surgeons who carry out abdominopelvic surgical procedures should be aware of well leg compartment syndrome, and instigate policies within their own institution to reduce the risk of this potentially life‐changing complication.
Early results show that the mechanochemical ablation is less painful than the radiofrequency ablation procedure. Clinical and quality of life scores were similarly improved at one month. The long-term data including occlusion rates at six months and quality of life scores are being collected.
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