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. 2021 Oct 12;2021(10):CD012723. doi: 10.1002/14651858.CD012723.pub2

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
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
Interventions Treatment 1: sclerotherapy with POL:air ratio 1:2
Treatment 2: sclerotherapy with POL:air ratio 1:4
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
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