Author, date and country | Patient group | Study type (level of evidence) | Outcomes | Key results | Study Weaknesses |
---|---|---|---|---|---|
Katz IA et al 2005 UK | 41 consecutive diabetic patients with chronic, non-ischaemic, neuropathic plantar foot ulcers | Randomized clinical trial | The proportion of patients with ulcers that healed at 9less than or equivalent to) 12 weeks | The proportions of patients with ulcers that healed within 12 weeks in the iTCC and TCC groups were 945 AND 935 respectively (once patients lost to follow up were excluded) | There is a small sample size and blinding couldnt be used |
healing rates | Healing rates were statistically significant in the two groups | ||||
complication rates | Complication rates were statistically significant within the two groups | ||||
cast placement/removal times | The i TCC took considerably less time to place and remove than the TCC with 39% and 36% reductions, respectively | ||||
costs | There was an overall lower cost associated with the use of the iTCC compared with the TCC | ||||
Piaggesi A et al 2007 USA | 40 diabetic out-patients attending foot clinic randomized to TCC or iTCC treatment. | A randomized prospective trial | Healing rates at 12 weeks | There was no difference observed in healing rates at 12 weeks (95% in the TCC group and 85% in the iTCC group) | This was a small trial and blinding was not possible |
Number and severity of adverse events | There was no significant difference in the number of adverse events (6 in the TCC group compared to 4 in the iTCC group) | ||||
Costs | The iTCC was significantly less expensive than the TCC (a mean reduction of costs of 78%) | ||||
Applicability of the device | The iTCC was a 77 and 58% reduction in the time required for application and removal of the devices respectively (P=0.001) | ||||
Patient satisfaction | Patient satisfaction was higher in the iTCC group (P=0.01) | ||||
Healing time | There was no significant difference in healing time (6.5 in the TCC group compared to 6.7 in the iTCC group) |