LivRelief varicose veins cream in the treatment of chronic venous insufficiency of the lower limbs: A 6-week single arm pilot study.

BACKGROUND: Chronic Venous Disease is characterized by morphological abnormalities of the venous system. Affected limbs are classified in increasing clinical severity with the Clinical Etiological Anatomical and Pathological system from C0 to C6. Limbs assessed at C3 through C6 meet the criteria of Chronic Venous Insufficiency. Chronic Venous Insufficiency of the Lower Limbs is a very common pathology affecting approximately ~40% of the world's population. This study observes the use of the LivRelief Varicose Vein Cream, a Natural Health Product that is licensed for sale by Health Canada, for use in the treatment of varicose veins. METHODS: An open label, single arm interventional, pilot study was conducted to determine the feasibility of recruitment and data collection in this population. To accomplish this, the cream was provided to all enrolled subjects. Subsequently, objective and subjective measures were performed at baseline and after 6 weeks of at-home use. Recruitment and data collection targets of at least 70% were established and the data collected at both timepoints were compared and analyzed using a paired t-test. Results were also reported as proportions where appropriate. RESULTS: A total of 32 subjects were enrolled. The pre-defined feasibility objectives for recruitment and data collection were met with the enrolment of 97% of all screened patients and the collection of 94% of all scheduled data. The most significant therapeutic improvement was seen in the results of the Venous Clinical Severity Score where 66% of the treated legs experienced a decrease in severity after 6 weeks of treatment. P values were <0.0001 and 0.0003 for the left and right leg, respectively. CONCLUSION: It is feasible to recruit and collect data with the chosen outcome assessments within this population. Preliminary results suggest that the product could improve some of the clinical symptoms associated with the presence varicose veins. These results warrant further exploration in a longer, randomized and placebo-controlled study. TRIAL REGISTRATION: Clinicaltrial.gov: NCT03653793.

Outcomes Following Advanced Wound Care for Diabetic Foot Ulcers: A Canadian Study.

OBJECTIVES: Data concerning outcomes of Canadian patients with diabetic foot ulcers (DFUs) are limited. The objectives of this study were to evaluate the healing rates and identify the predictors of poor outcomes following advanced wound care in patients presenting with DFUs. METHODS: We conducted retrospective cohort study of adult patients who had DFUs and were referred to a single Canadian advanced diabetic foot and wound care centre between January 1, 2010, and December 31, 2010. The primary outcome was the healing rate at 52 weeks. The generalized estimating equation model was used to identify potential risk factors associated with delayed healing of DFUs. RESULTS: Of the 40 patients for whom there were complete follow ups, 35 (87.5%) had healing of all DFUs by 52 weeks. Predictors of poor healing were the presence of chronic ulcers, ulcer sizes >1 cm2, peripheral vascular disease and multiple ulcers at first presentation. Of the patients, 7.1% required amputation, and 8.9% of patients receiving our treatment died before 52 weeks. At 52 weeks of follow up, 16 of 17 recurrent ulcers and 68 of 108 pre-existing ulcers had healed. Compared to the unadjusted healing rate of preexisting ulcers (63.0%), the unadjusted healing rate of recurrent ulcers (94.1%) was significantly higher (p=0.01). CONCLUSIONS: Our findings demonstrate that patients with DFUs in Canada who receive early and continued care from specialized, outpatient, advanced wound care centres experience significantly improved rates of healing of recurrent DFUs compared to pre-existing DFUs.

Once-daily administration of budesonide Turbuhaler was as effective as twice-daily treatment in patients with mild to moderate persistent asthma.

In a double-blind, randomized, placebo-controlled trial, 288 patients with mild to moderate persistent asthma currently on inhaled glucocorticosteroids (GCSs) were treated with budesonide Turbuhaler, 200 microg once every night (q.n.), 100 microg twice-daily (b.i.d.), or placebo b.i.d. After 12 weeks, morning peak expiratory flow (PEF) increased in both groups treated with budesonide but decreased in placebo-treated patients. Symptom scores and bronchodilator use were significantly reduced in both groups receiving active treatment (p = 0.023-0.0001) compared with patients treated with placebo. There was no significant difference in outcome measurements between the two budesonide regimens. Thus, patients with mild to moderate persistent asthma receiving b.i.d. treatment with inhaled GCSs can usually be switched to budesonide Turbuhaler, 200 microg, q.n. without loss of asthma control.