Kibbe 2014.

Methods	Study design: multi‐centre phase IIa double‐blind placebo‐controlled randomised trial Intention‐to‐treat: not reported Country: not reported
Participants	Number randomised: N = 48 Losses to follow‐up and withdrawals: not reported Age (mean years ± SD): 58.6 ± 13.7 Gender (M): 88% Inclusion criteria: CLI (Rutherford 4 or 5); poor candidates for surgical revascularisation; receiving stable medical therapy; ankle systolic pressure ≤ 70 mmHg or toe systolic pressure ≤ 50 mmHg Exclusion criteria: not reported
Interventions	Treatment: plasmid stromal cell‐derived factor‐1 (pSDF‐1), 4 cohorts, single set of direct intramuscular injections (8 or 16) to the ischaemic limb at escalating doses of 1 mg/mL pSDF‐1 (4, 8, 8, or 16 mg) Control: placebo
Outcomes	Follow‐up times: 12 months Outcomes: QoL (SF‐36), VAS, Rutherford class, Time to first/Number of amputations, Wound healing, Survival
Notes	Study period: enrolment completed July 2013 Only conference proceedings available from interim report; stated 12‐month data would be available September 2014
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	Support from Juventas Therapeutics