Infrared thermography and ulcer prevention in the high‐risk diabetic foot: data from a single‐blind multicentre controlled clinical trial

Objectives: Perfusion and blood oxygen levels are frequently insufficient in patients with hard-to-heal wounds due to poor circulation, vascular disruption and vasoconstriction, reducing the wound's capacity to heal. This study aimed to investigate the effect of topical oxygen on healing rates in patients with hard-to-heal diabetic foot ulcers (DFUs) (i.e., non-responsive over four weeks). Method: This multicentre, open-label, community-based randomised clinical trial compared standard care (SOC) with or without continuous topical oxygen therapy (TOT) for 12 weeks in patients with DFUs or minor amputation wounds. SOC included debridement, offloading with total contact casting (TCC) and appropriate moisture balance. Primary endpoints were the number of patients to achieve complete wound closure and percentage change in ulcer size. Secondary endpoints were pain levels and adverse events. Results: For the study, 145 patients were randomised with index ulcers graded Infectious Diseases Society of America (IDSA) 1 or 2, or Wagner 1 or 2. In the intention-to-treat analysis, 18/64 (28.1%) patients healed in the SOC group at 12 weeks compared with 36/81 (44.4%) in the SOC plus TOT group (p=0.044). There was a statistically significant reduction in wound area between the groups: SOC group mean reduction: 40% (standard deviation (SD) 72.1); SOC plus TOT group mean reduction: 70% (SD 45.5); per protocol p=0.005). There were no significant differences in changes to pain levels or adverse events. Conclusion: This study suggests that the addition of TOT to SOC facilitates wound closure in patients with hard-to-heal DFUs.

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Intravenous paracetamol versus ketorolac for pain attenuation in patients with renal colic; a randomized, single blind and controlled clinical trial

Journal of Renal Injury Prevention ◽

10.34172/jrip.2020.10 ◽

2020 ◽

Vol 9 (2) ◽

pp. e10-e10

Author(s):

Arash Ardestani Zadeh ◽

Davood Arab ◽

Mohammadreza Moonesan ◽

Majid Mirmohammadkhani ◽

Pouya Morid

Keyword(s):

Clinical Trial ◽

Adverse Effects ◽

Renal Colic ◽

Vital Signs ◽

Analgesic Efficacy ◽

Controlled Clinical Trial ◽

Randomized Controlled ◽

Intravenous Paracetamol ◽

Significant Difference ◽

Single Blind

Introduction: Pain control is an essential care for patients with renal colic in emergency wards. Objectives: This study aimed to compare the analgesic efficacy of intravenous (IV) paracetamol (PC) versus ketorolac (KET) for patients with renal colic. Patients and Methods: In a randomized controlled clinical trial, 110 patients with renal colic referred to the emergency department of Kosar hospital, Semnan between October 2015 and June 2016 were selected. Eighty-eight patients were divided into two groups (44 patients in each group) of PC (1 g/IV) and KET (30 mg/IV). One patient in each group was excluded during the study. Vital signs and pain severity (measured by visual analogue scale [VAS]) of all patients were recorded at admission time 0, 20, 40 and 60 minutes after treatment. Then, the results were compared in two groups. Results: The results showed that at the time of 0, 20, 40 and 60 minutes after the administration of the PC and KET drugs, no significant difference was seen in severity of pain based on VAS score between the two groups (P<0.05). Moreover, there were no significant differences in the vital signs of two groups (P<0.05). No adverse effects were reported in each group. Conclusion: In conclusion, the use of IV-PC and KET in patients with renal colic had similar pain relieving effects without any adverse effects.

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