Hoss 2020.
Study characteristics | ||
Methods |
Study design: prospective, randomised, double‐blind, split‐leg, single‐centre clinical trial Method of randomisation: not mentioned Blinding: participant ‐ yes; treating doctor ‐ yes; outcome assessors ‐ yes Power calculation: not mentioned Total number of participants: 30 Total number of procedures: 60 Treatment localisation: leg veins Number of exclusions post‐randomisation: none Number of withdrawals and reasons: none |
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Participants |
Setting: outpatient site Country: USA Gender: women Age: mean 53.6 (32 ‐ 70 years) Inclusion criteria: varicose, reticular or telangiectatic leg veins, or both Exclusion criteria: CEAP class C2 or greater, history of DVT, pregnancy, allergy |
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Interventions |
Treatment 1: sclerotherapy with POL:air ratio 1:2 Treatment 2: sclerotherapy with POL:air ratio 1:4 |
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Outcomes | Efficacy was rated on a quartile percentage scale (1 = 0% – 25%, 2 = 26% – 50%, 3 = 51% – 75%, and 4 = 76% – 100%) Adverse events: erythema, pigmentation,urtication/swelling, ankle/pedal oedema, ecchymosis, ulceration, matting, hyperpigmentation |
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Funding sources | No details provided | |
Declarations of interest | None declared | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details given |
Allocation concealment (selection bias) | Unclear risk | No details given |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Both participants and evaluating investigators were blinded to the randomisation schedule |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Both participants and evaluating investigators were blinded to the randomisation schedule |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No details given |
Selective reporting (reporting bias) | Unclear risk | No details given |
Other bias | Unclear risk | No details given |