Cazzaniga 2014.
Methods | Randomised, within‐patient clinical trial Three centres in Italy Period of inclusion: March 2010 to June 2012 |
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Participants |
Inclusion criteria
Exclusion criteria
Baseline data: dressing sides were uniformly randomised on a 1:1 basis to sock made of fluorine‐synthetic fibre (17 soles) or sock made of cotton fabric (17 soles)
Withdrawal: 3 participants were lost to follow‐up because of bad compliance; 1 withdrew from the study after the second week for worsening of pathological conditions |
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Interventions |
Intervention A: sock made of fluorine‐synthetic fibre (17 soles) Control Intervention B: sock made of cotton fabric (17 soles) Co‐interventions: topical corticosteroids or vitamin D derivatives Duration of treatment: 4 weeks |
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Outcomes |
Primary outcome
Secondary outcomes
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Notes | This trial was supported by a grant from Lenzi Egisto S.p.A. Clinical trial: NCT01197989 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Dressing sides were uniformly randomised on a 1: 1 basis. Centralised telephone randomisation procedures were adopted" Comment: probably done |
Allocation concealment (selection bias) | Low risk | Quote: "Centralized telephone randomisation procedures were adopted, and both investigators and outcomes assessor were blinded to the randomisation rule" Comment: probably done |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Both socks were tailor‐made by the study sponsor in order to be as similar as possible regarding colour, model and texture of fabric" Comment: patients and personnel were unaware of the socks used |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Both socks were tailor‐made by the study sponsor in order to be as similar as possible regarding colour, model and texture of fabric. Both investigators and outcomes assessor were blinded to the randomisation rule" Comment: probably done |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Three patients dropped out of the study for low compliance rate, one after baseline, one after the first week and one after the second week, while one patient withdrew from the study after the second week for worsening of pathological conditions (loss of 23.5% of enrolled patients). An intention‐to‐treat approach was adopted in the primary analysis. In this analysis, patients lost to follow‐up were recovered by the last observation carried forward technique. Intention‐to‐treat analysis was then complemented by per‐protocol analyses, which considered only those patients who completed the study period" Comment: intention‐to‐treat approach was adopted. So, we know how they dealt with missing data |
Selective reporting (reporting bias) | Low risk | Comment: the study protocol is available and all of the study’s pre‐specified (primary and secondary) outcomes of interest in the review have been reported in the pre‐specified way |