| Study | Reason for exclusion |
|---|---|
| Abraira 1992 | Foot ulcer healing outcomes or other outcomes relevant to this review were not investigated in study, authors were unable to provide additional data for analyses |
| Abraira 2003 | Foot ulcer healing outcomes or other outcomes relevant to this review were not investigated in study, authors were unable to provide additional data for analyses |
| ACTRN12606000426583 | Study prematurely terminated/ was not finished |
| Althouse 2013 | Foot ulcer healing outcomes or other outcomes relevant to this review were not investigated in study. PAD, lower‐extremity revascularization and non‐ulcer‐specific lower extremity amputation were documented, but the two intervention arms did not meet inclusion criteria. All participants were treated with a target HbA1c of 7.0% |
| Bayat 2013 | Participants were not in intensive versus conventional glycaemic control arms for comparison |
| Bloomgarden 1987 | Foot ulcer outcomes or other outcomes relevant to this review were not investigated in study.The study only investigated incidence of foot ulceration and the impact of ulcer prevention interventions on ulcer incidence |
| Boaz 2009 | Foot ulcer healing outcomes or other outcomes relevant to this review were not investigated in study. The study assessed the role of prevention and active checking of foot and leg sores |
| Calles‐Escandon 2010 | Foot ulcer healing outcomes or other outcomes relevant to this review were not investigated in study. The study investigated mortality as an outcome from intensive control verses conventional control and the authors were unable to provide additional data for analyses |
| Chiu 2011 | Participants were not in intensive versus conventional glycaemic control arms for comparison |
| Christiansen 2009 | Foot ulcer healing outcomes or other outcomes relevant to this review were not investigated in study. Study reported all‐cause amputation and ulcer specific or related amputation data were unable to be provided |
| Clark 2001 | Participants were not randomised to intensive or conventional glycaemic control arms for comparison |
| Dormandy 2005 | Foot ulcer healing outcomes or other outcomes relevant to this review were not investigated in study. One secondary outcome was amputation above the ankle however this was not related to ulcers. Authors were unable to provide any additional data |
| Duckworth 2009 | Foot ulcer healing outcomes or other outcomes relevant to this review were not investigated in study. The authors were unable to provide additional data for analyses. The study investigated the incidence of neuropathy and neuropathic ulcers with intensive versus conventional control as a prevention measure |
| Fresenius 2009 | Participants were not in intensive versus conventional glycaemic control arms for comparison |
| Gaede 2006 | Foot ulcer healing outcomes or other outcomes relevant to this review were not investigated in study. Amputation results were based on vascular causes rather than causes related to foot ulceration. Authors were unable to provide additional clarification |
| Gaede 2003 | Foot ulcer healing outcomes or other outcomes relevant to this review were not investigated in study and the authors were unable to provide additional data for analyses |
| Garber 2002 | Foot ulcer healing outcomes or other outcomes relevant to this review were not investigated in study |
| Gram 2011 | Foot ulcer healing outcomes or other outcomes relevant to this review were not investigated in study |
| Griffin 2011 | Foot ulcer healing outcomes or other outcomes relevant to this review were not investigated in study and the authors were unable to provide any additional data. This was a population‐level study with the unit of analyses not focused on participants or ulcers |
| Jarnert 2012 | Participants were not in intensive versus conventional glycaemic control arms for comparison |
| Kawamori 2010 | Foot ulcer healing outcomes or other outcomes relevant to this review were not investigated in study. Only PAD outcomes were reported and composite outcomes in relation to PAD and other outcomes were reported |
| Kostev 2012 | Non‐randomised study design |
| Leung 2012 | Participants were not in intensive versus conventional glycaemic control arms for comparison |
| Li 2008 | Participants were not in intensive versus conventional glycaemic control arms for comparison |
| Litzelman 1993 | Participants were not in intensive versus conventional glycaemic control arms for comparison |
| Marso 2013 | Foot ulcer healing outcomes or other outcomes relevant to this review were not investigated in this study. The study stated diabetic foot ulcers as a tertiary outcome but did not report data. Authors were unable to provide any additional data |
| Martinez‐Sanchez 2005 | Participants were not in intensive versus conventional glycaemic control arms for comparison |
| McMurray 2002 | Participants were not in intensive versus conventional glycaemic control arms for comparison |
| Meigs 2003 | Participants were not in intensive versus conventional glycaemic control arms for comparison |
| Nathan 2009 | Foot ulcer healing outcomes or other outcomes relevant to this review were not investigated in this study and authors were unable to provide additional data for analyses. Study reported outcomes on amputation related to severe neuropathy but not foot ulcers |
| NCT00850798 | Foot ulcer healing outcomes or other outcomes relevant to this review were not investigated in this study |
| NCT01421966 | Participants were not in intensive versus conventional glycaemic control arms for comparison |
| NCT01813305 | Participants were not in intensive versus conventional glycaemic control arms for comparison |
| Nybo 2011 | Foot ulcer healing outcomes or other outcomes relevant to this review were not investigated in this study and the authors were unable to provide any additional data |
| Pedersen 2003 | Foot ulcer healing outcomes or other outcomes relevant to this review were not investigated in this study. Study reported amputations likely related to vascular causes and the authors were unable to provide any additional data |
| Rong 2012 | Participants were not in intensive versus conventional glycaemic control arms for comparison |
| Sullivan 2009 | Non‐randomised study design |
| Timlin 2010 | Foot ulcer healing outcomes or other outcomes relevant to this review were not investigated in this study |
| UK Prospective Diabetes Study (UKPDS) Group 1998 | Foot ulcer healing outcomes or other outcomes relevant to this review were not investigated in this study. Authors stated that outcomes in relation to foot ulcers were not collected |
| Vaccaro 2012 | Foot ulcer healing outcomes or other outcomes relevant to this review were not investigated in this study. The study investigated major leg amputations (above the ankle) and these were not in relation to foot ulcers |
| Vadstrup 2009 | Foot ulcer healing outcomes or other outcomes in relation to intensive versus conventional glycaemic control were not reported. Authors could not provide data on ulcer specific outcomes |
| Van Olmen 2013 | Foot ulcer healing outcomes or other outcomes in relation to intensive versus conventional glycaemic control were not reported. The main outcome measure is number of foot ulcers, this study is ongoing currently. No preliminary results published to date. Proportion of patients with good glycaemic control used rather than mean HbA1c to randomise patients. Authors were unable to provide any further information |
| Williams 2012 | Foot ulcer healing outcomes or other outcomes in relation to intensive versus conventional glycaemic control were not reported. Foot inspections were reported however this was not in relation to foot ulcers or ulcer healing outcomes. Authors were unable to provide any further information |
| Zhang 2011 | Localised injection of insulin improved systemic glycaemic control, however foot ulcer healing outcomes or other outcomes in relation to intensive versus conventional glycaemic control were not reported. The author was unable to provide any additional information |
| Zhang 2013 | Foot ulcer healing outcomes or other outcomes in relation to intensive versus conventional glycaemic control were not reported. Outcomes reported were not specific to the impact of glycaemic control |
| Zhenghua 2011 | Participants were not in intensive versus conventional glycaemic control arms for comparison |
Please note that when 'foot ulcer outcomes not investigated in study' was used as a reason for exclusion this was based on whether studies reported outcomes as deemed appropriate as per the review protocol and/or where data were not available from authors or where no primary outcomes were investigated at all.