TALISMAN‐202.

Methods	Study design: stated as randomised, placebo‐controlled, double‐blind, phase II trial. Multicentre trial (US hospitals) Recruitment: June 2002 – July 2005 (USA)
Participants	People with critical limb ischaemia and with unhealing ulcer who were poor or not candidates for revascularisation (N randomised = 71) Age: 45 years and older Sex (N males/females): no data Severity: no data
Interventions	NV1FGF: non‐viral 1 fibroblast growth factor 4 sessions (every 2 weeks) of 8 IM injections NV1FGF: 1 of 5 treatment regimens; 2 to 16 mg; n randomised not reported 4 sessions (every 2 weeks) of 8 IM injections placebo; n randomised not reported
Outcomes	Efficacy: change in tcpO2 (primary), ABI, TBI, ulcer healing, amputation, death Safety
Notes	Study completed 2005, but results not published (no reply to our enquiry)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Procedure is not explicitly reported
Allocation concealment (selection bias)	Unclear risk	Procedure is not explicitly reported
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Blinding procedure is not explicitly reported
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Outcome measurement is not likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) Subjective outcomes	Unclear risk	Blinding procedure is not explicitly reported
Incomplete outcome data (attrition bias) Death	Unclear risk	Results not presented
Incomplete outcome data (attrition bias) Limb amputation	Unclear risk	Results not presented
Incomplete outcome data (attrition bias) Ulceration	Unclear risk	Results not presented
Incomplete outcome data (attrition bias) Rest pain	Unclear risk	Results not presented
Incomplete outcome data (attrition bias) Walking ability	Unclear risk	Results not presented
Incomplete outcome data (attrition bias) Haemodynamic measures	Unclear risk	Results not presented
Incomplete outcome data (attrition bias) Adverse events /severe complications	Unclear risk	Results not presented
Selective reporting (reporting bias)	High risk	Study completed, but results not published
Other bias	Unclear risk	Insufficient information to assess whether an important risk of bias exists