Henry 2006.

Methods	Study design: multi‐centre phase II double‐blind placebo‐controlled randomised study Intention‐to‐treat: not reported Country: USA
Participants	Number randomised: N = 71 Losses to follow‐up and withdrawals: not reported Age (mean years ± SD): not reported Gender (M): not reported Inclusion criteria: 45 years old; informed consent signed before proceeding with any study procedure; severe PAD; trophic lesions with no signs of healing for at least 2 weeks before first study treatment administration; objective evidence of peripheral vascular disease in the diseased limb on 2 consecutive examinations performed at least 1 week apart; demonstration or documentation of total occlusion of the affected limb of 1 or more iliac, superficial femoral, popliteal, and/or 1 or more infrapopliteal arteries as assessed by angiography or magnetic resonance angiography; mean resting supine TcPO₂ of the foot ≤ 40 mmHg based on 2 separate measures performed at least 1 week apart; poor/not candidates for revascularisation Exclusion criteria: previous or current history of malignant disease; positive cancer screening; successful lower extremity surgery; planning to undergo amputation of target limb within 1 month following first administration of study treatment; history of severe renal failure; creatinine > 2.0 mg/dL or estimated creatinine clearance < 30 mL; serious concomitant medical conditions not adequately controlled; Buerger's disease; on dialysis; active proliferative retinopathy with stroke or neurological deficit presumed to be due to stroke within 3 months before first administration of study treatment; previous treatment with any angiogenic growth factor; positive serology for HIV 1 or 2; participation in clinical trials of non‐approved experimental agents within 4 weeks before study entry
Interventions	Treatment: NV1FGF, 1 of 5 treatment regimens of 2 to 16 mg, delivered by 8 intramuscular injections in the affected leg every 2 weeks for 4 sessions Control: placebo
Outcomes	Follow‐up times: not reported, but 1 reference suggests between 1 and 3 years Outcomes: TcPO₂, Ulcer healing
Notes	Study period: June 2002 to July 2005 NCT00798005
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information provided to determine random sequence generation
Allocation concealment (selection bias)	Unclear risk	Insufficient information provided to determine allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Described as double‐blind and used placebo but did not describe how placebo was disguised for personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information provided to determine blinding of outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No information reported on study population during follow‐up
Selective reporting (reporting bias)	Unclear risk	Insufficient information to determine selective reporting bias
Other bias	Unclear risk	Sponsored by Sanofi