Signorelli 2006b.
| Study characteristics | ||
| Methods | Randomized placebo‐controlled double‐blind clinical trial | |
| Participants | 64 patients with intermittent claudication on hemodialysis (chronic kidney insufficiency) No dropouts were reported | |
| Interventions | Intervention (32): PLC 600 mg iv in saline solution 3 times/week during 1 year Control (32): placebo: only saline solution infusion 3 times/week during 1 year | |
| Outcomes | ABI by continuous Doppler pulse wave Plasma MDA Plasma 4‐HNE Plasma nitrite/nitrate Measurements at baseline and at 6 and 12 months | |
| Notes | No walking distances reported in this study No funding reported |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "using a simple randomisation scheme, patients were assigned to one of two groups" |
| Allocation concealment (selection bias) | Unclear risk | No description of method of concealment |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double‐blind study" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding of outcome assessment assumed, hence no influence on outcome assessment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts; all data reported (ABI) |
| Selective reporting (reporting bias) | Low risk | No selective reporting concerns |
| Other bias | Low risk | No further concerns; however, no statement on conflict of interest |
4‐HNE: 4‐hydroxynonenal (biomarker of oxidative stress and lipid peroxidation). ABI: ankle brachial index. ACD: absolute claudication distance. COT: claudication onset time. CSA: cross‐sectional area. FAS: full analysis set. ITT: intention‐to‐treat (population). iv: intravenously. LC: L(evo)‐carnitine. MDA: malondialdehyde (indicators of lipid peroxidation). MWD: maximal walking distance. NIDDM: non‐insulin‐dependent diabetes mellitus. PAD: peripheral arterial disease. PFWD: pain‐free walking distance. PLC: propionyl‐L(evo)‐carnitine. PP: per‐protocol (population). PPS: per‐protocol set. PWT: peak walking time.