6. Outcomes.

	Resolution of infection	Incidence of wound infection	Time to healing	Proportion of wounds healed	Microbial counts	Health‐related quality of life	Need for surgical resection, including partial or complete lower limb amputation	Safety (adverse events)
Ahmed 2014 Group 1: (n = 30) Povidone iodine bath and saline Vaseline gauze dressing Group 2: (n = 30) Phenytoin powder plus povidone iodine bath and saline Vaseline gauze dressing Not infected at baseline	Not reported	Not reported	Not reported	Not reported	Not reported	Not reported	Not reported	Not reported
Apelqvist 1996 Group 1: (n = 19) Gentamicin solution Group 2: (n = 22) Cadexomer iodine ointment Baseline infection status not reported.	Not reported	Not reported	Not reported	Group 1: 2/18 Group 2: 5/17	Not reported	Not reported	Surgical resection was reported: Group 1: 5/19 Group 2: 3/22	Study reports that no adverse reactions related to the topical treatment were documented.
Bergqvist 2016 Group 1: (n = 19) Standard care alone Group 2: (n = 21) Chloramine plus standard care Infected at baseline	Group 1: 7/15 Group 2: 9/13	Not reported	Time‐to‐event data presented with no reported hazard ratio. Given the small number of participants and events, no further attempts were made to calculate time‐to‐event values.	Healed at 24 weeks Group 1: 9/17 Group 2: 10/17	Not reported	Not reported	Vascular procedure or amputation Group 1: 3/17 Group 2: 5/17	Adverse event data reported but unable to get a per‐participant value, as it is noted that some participants had more than 1 event.
Bowling 2011 Group 1: (n = 10) Saline solution Group 2: (n = 10) Super‐oxidised aqueous solution Not infected at baseline	Not reported	Not reported	Not reported	Study notes that 15% of the study ulcers were healed, but this information not reported by group.	The bacterial load in the wound bed was defined as scattered (0/+), light (+), medium (++), or heavy (+++). At week 4 there was a reduction of 33% in the bacterial load versus baseline. Figure presented but difficult to interpret data by group.	Not reported	Not reported	No safety concerns were reported in either the super‐oxidised aqueous solution group or the saline group; no adverse reactions were recorded.
Gottrup 2013 Group 1: (n = 15) Foam dressing Group 2: (n = 24) Silver collagen/oxidised regenerated cellulose dressing Not infected at baseline	Not reported	Wound infection Group 1: 4/13 Group 2: 0/23	Not reported	Healed by week 14 Group 1: 4/13 Group 2: 12/23	Not reported	Not reported	Not reported	Limited details of adverse events (in addition to infection data already recorded). There were no reported adverse events related to the use of collagen/oxidised regenerated cellulose/silver dressing, and 5 cases of adverse events (no further details) related to foam dressing.
He 2016 Group 1: (n = 40) Routine debridement plus standard care Group 2: (n = 40) Silver ion dressing plus standard care Baseline infection status not reported.	Not reported	Not reported	Mean wound healing time in days: Group 1: 47.4 ± 11.5 Group 2: 31.3 ± 8.2 Mean granulation tissue occurrence time in days: Group 1: 10.8 ± 1.9 Group 2: 6.4 ± 0.72	Group 1: 15/40 Group 2: 24/40	Not reported	Not reported	Not reported	Not reported
Hwang 2010	Not reported	Not reported	Not reported	Not reported	Not reported	Not reported	Not reported	Not reported
Imran 2015 Group 1: (n = 180) Treated with normal saline dressing Group 2: (n = 195) Treated with honey dressing	Not reported	Not reported	Median healing time in honey group is 18 days (IQR is 6 to 120), and in the saline group is 29 days (IQR 7 to 120). Data do not seem to have been calculated using correct time‐to‐event approaches and were not considered further.	Group 1: 97/169 Group 2: 136/179	Not reported	Not reported	Not reported	Not reported
Jacobs 2008 Group 1: (n = 20) Silver sulphadiazine Group 2: (n = 20) Formulation of benzoic acid, 6%; salicylic acid, 3%; and extract of oak bark (Quercus rubra), 3% (Bensal HP with QRB7), with silver sulphadiazine cream Baseline infection status not reported.	Not reported	Not reported	Not reported	Healed by week 6 Group 1: 6/20 Group 2: 8/20	Not reported	Not reported	Not reported	Not reported
Jeffcoate 2009 Group 1: (n = 108) Non‐adherent dressing, viscose filament gauze (Johnson & Johnson) Group 2: (n = 103) Hydrocolloid (Hydrofiber) dressing (Aquacel, ConvaTec) Group 3: (n = 106) Iodine‐containing dressing (Inadine, Systagenix) Baseline infection status not reported.	Not reported	Number of infected ulcers at 24 weeks: not reported by group Study reports the number of episodes of infection listed as serious adverse events, but it is unclear if foot infections, and not clear how many people had how many infection events.	Mean time to healing in days (SD) (fixed at max of 168 days) Group 1: 130.7 (52.4) Group 2: 125.8 (55.9) Group 3: 127.8 (54.2) Not all ulcers healed, so mean is inappropriate measure of time to healing.	Number of ulcers healed at 24 weeks: Group 1: 41/108 Group 2: 46/103 Group 3: 48/106	Not reported	Mean Cardiff Wound Impact Schedule score at 24 weeks (SD) Group 1: Physical functioning: 68.9 (19.1). Social functioning: 69.8 (23.5). Well‐being: 50.2 (21.1) Group 2: Physical functioning: 71.4 (19.5). Social functioning: 70.3 (25.4). Well‐being: 53.1 (19.9) Group 3: Physical functioning: 67.1 (23.6). Social functioning: 69.7 (24.1). Well‐being: 51.0 (22.3) Other Study also reports mean and SD for each of the 8 domains of the SF‐36. There was no significant difference between the groups for any domain.	Minor amputations (below ankle): Group 1: 1/108 Group 2: 3/103 Group 3: 1/106 Major amputations (above knee) Group 1: 1/108 Group 2: 1/103 Group 3: 0/106 n not clear; assumed to be all participants	Non‐serious adverse events Group 1: 244/108 Group 2: 227/103 Group 3: 239/106 Serious adverse events Group 1: 35/108 Group 2: 28/103 Group 3: 37/106 Not clear how many participants had how many events, but seems to be more than 1 per person; data not analysed further
Jude 2007 Group 1: (n = 67) Calcium‐alginate dressing Group 2: (n = 67) Fibrous‐hydrocolloid (Hydrofiber) dressing with 1.2% ionic silver Mixed wound infection status at baseline	Not reported	Group 1: 11/67 Group 2: 8/67	Time to 100% healing also reported, but this is only for a subset of those that healed, so not a useful pan‐study measure. Not reported Mean time to healing in days Group 1: 52.6 ± 1.8 Group 2: 57.7 ± 1.7	Number of ulcers healed in 8 weeks Group 1: 15/67 Group 2: 21/67	Not reported	Not reported	Not reported	Group 1: 26/67 participants experienced adverse event. Death = 1; Infection = 8. 13 participants discontinued treatment due to adverse event. Group 2: 25/67 participants experienced 1 or more events. Death = 1; Infection = 14. 8 participants discontinued treatment due to adverse event.
Khandelwal 2013 Group 1: (n = 20) Hyperbaric oxygen therapy (not considered in review) Group 2: (n = 20) Recombinant human platelet‐derived growth factor Group 3: (n = 20) Antiseptic dressings	Not reported	Not reported	Mean time to healing in weeks (standard error) Group 1: 6.83 (2.5) Group 2: 7.6 (2.5) Group 3: 6.75 (2.7) Not all ulcers healed, so mean is inappropriate measure of time to healing.	Number of ulcers healed Group 1: 12/20 Group 2: 16/20 Group 3: 8/20 Review authors calculated figures from graph.	Not reported	Not reported	Not reported	Not recorded
Landsman 2011 Group 1: (n = 21) Levofloxacin plus saline Group 2: (n = 21) Super‐oxidised aqueous solution alone (not considered) Group 3: (n = 25) Levofloxacin plus super‐oxidised aqueous solution Ulcers infected at baseline.	Group 1: 6/21 Group 2: 11/21 Group 3: 11/25	Not reported	Not reported	Mentioned, but data not presented.	Not reported	Not reported	Not reported	Adverse events (number of participants with 1 or more event) Group 1: 7/21 Group 2: 7/21 Group 3: 9/25
Lipsky 2008a Group 1: (n = 246) Ofloxacin Group 2: (n = 247) Pexiganan Ulcers infected at baseline.	Not reported Resolution ("cure") and improvement data presented together, so unclear how many participants had resolution.	Not reported	Not reported	Not reported	Not reported	Not reported	See below ‐ results presented by study authors cumulatively for these 2 studies only.	Adverse events (number of participants with > 1 adverse event) Group 1: 109/246 Group 2: 98/247
Lipsky 2008b Group 1: (n = 171) Ofloxacin Group 2: (n = 171) Pexiganan Ulcers infected at baseline.	Not reported Resolution ("cure") and improvement data presented together, so unclear how many participants had resolution.	Not reported	Not reported	Not reported	Not reported	Not reported	Group 1: 9/417 Group 2: 11/418 (cumulative of two RCTs reported in single paper)	Adverse events (number of participants with > 1 adverse event) Group 1: 84/171 Group 2: 76/171
Lipsky 2012a Group 1: (n = 18) Systemic antibiotic therapy alone Group 2: (n = 38) Topical application of the gentamicin‐collagen sponge + systemic antibiotic therapy Ulcers infected at baseline.	Resolution of infection by 7 days Group 1: 7/18 Group 2: 22/38	Not reported	Not reported	Not reported	Not reported	Not reported	Not reported	Adverse events (number of participants with 1 or more events) Group 1: 5/18 Group 2: 11/38
Martinez‐De Jesus 2007 Group 1: (n = 16) Standard management with chemical antiseptics such as soap or povidone iodine Group 2: (n = 21) Super‐oxidised aqueous solution	Advances from infection to granulating tissue: Group 1: 10/16 Group 2: 19/21	Not reported	Not reported	Not reported	Not reported	Not reported	Not reported	Not reported
Ramos Cuevas 2007 Group 1: (n = 25) Conventional treatment (no further details translated) Group 2: (n = 25) Zinc hyaluronate	Not reported/translated	Not reported/translated	Mean time to healing in weeks (not clear if standard deviation or standard error presented) Group 1: Only 2 ulcers healed; no time‐to‐event data reported Group 2: 7.80 (3.49) with all ulcers healing	Group 1: 2/25 Group 2: 25/25	Not reported/translated	Not reported/translated	Not reported/translated	Not reported/translated
Shukrimi 2008 Group 1: Standard‐dressing group (povidone iodine solution 10%) Group 2: Honey dressing group 30 participants randomised, but number in each group not specified.	Not reported	Not reported	Time to healing in days Group 1: 15.4 days (range 9 to 36 days) Group 2: 14.4 days (range 7 to 26 days) Comment: mean and range, but no measure of variation provided. Unclear how many participants in each group and how many ulcers healed, thus if this measure is a valid time‐to‐healing measure	Not reported	Not reported	Not reported	Not reported	Not reported
Tom 2005 Group 1: Normal saline solution, 11 ulcers (in 10 participants) Group 2: Tretinoin group, 13 ulcers (in 12 participants)	Not reported	Not reported	Data presented as time‐to‐event figure with no further data. Given the small number of participants and events, we have not tried to analyse further.	16 weeks Group 1: 2/10 Group 2: 6/12 Unclear if ulcers were healed in the same or different participants; for the analysis we have assumed in different participants	Not reported	Not reported	Not reported	Not reported
Ullal 2014 Group 1: (n = 2) Povidone iodine and metronidazole 1% gel dressing Group 2: (n = 2) Honey and metronidazole 1% gel dressing	Not reported	Not reported	Not reported	Group 1: 0/2 Group 2: 2/2	Not reported	Not reported	Not reported	Not reported
Viswanathan 2011 Group 1: (n = 19) Polyherbal formulation Group 2: (n = 19) Silver sulphadiazine cream	Not reported	Not reported	"Number of days taken for healing of the wound: Group 1: 43.1 ± 26.8 Group 2: 43.6 ± 30.7" Not clear what sort of analysis was conducted	Healing was defined as complete epithelialisation either by secondary intention or by split skin graft. However, figures are not reported.	"the microbiological investigations were not done"	Not reported	Not reported	"There were no adverse events reported in both the groups."

Abbreviations: IQR, interquartile range; SD, standard deviation