TABLE 4.
Evidence statements from systematic review for offloading interventions to heal neuropathic plantar forefoot or midfoot ulcers in patients with diabetes, unless otherwise stateda
| Outcome | Evidence Statement | Qualityb | References |
|---|---|---|---|
| PRIMARY: Healing | |||
| Nonremovable offloading device | Nonremovable knee-high offloading devices are more effective than removable offloading devices to heal the DFU. | High | Health Quality Ontario 2017,12 Elraiyah et al 2016,13 Martins de Oliveira and Moore 2015,15 Morona et al 2013,53 and Lewis and Lipp 201352 |
| TCCs and non-removable knee-high walkers are equally effective to heal the DFU. | Moderate | Health Quality Ontario 2017,12 Morona et al 2013,53 and Miyan et al 201436 | |
| Removable offloading device | Removable knee-high offloading devices and removable ankle-high offloading devices are equally effective to heal the DFU. | Moderate | Health Quality Ontario 201712 and Bus et al 201816 |
| Footwear | Therapeutic footwear is less effective than non-removable knee-high offloading devices to heal the DFU. | Moderate | Health Quality Ontario 2017,12 Elraiyah et al 2016,13 Morona et al 2013,53 and Miyan et al 201436 |
| Other offloading technique | Felted foam (with an aperture cut to the DFU location) attached to either the foot or the insole in a removable ankle-high offloading device seems to be more effective to heal the DFU than only wearing a removable ankle-high offloading device. | Low | Zimny et al 200368 and Birke et al 200277 |
| Surgical offloading technique | Achilles tendon lengthening in addition to a non-removable offloading device seems equally effective to heal the DFU as a non-removable offloading device alone | Low | Dallimore and Kaminski 201514 |
| Metatarsal head resection(s) in combination with a removable offloading device seems more effective to heal a neuropathic plantar metatarsal head DFU than using a removable offloading device alonea | Low | Kalantar Motamedi et al 2017,80 Armstrong et al 2012,82 Armstrong et al 2005,61 and Piaggesi et al 199872 | |
| Medial column arthrodesis in combination with a non-removable offloading device is not superior in healing a neuropathic plantar midfoot DFU associated with a Charcot deformity than using a non-removable offloading device alonea | Low | Wang et al 201569 | |
| First metatarsal-phalangeal joint arthroplasty in combination with non-removable offloading device may lead to shorter time-to-healing a neuropathic plantar hallux DFU than using a non-removable offloading device alonea | Low | Armstrong et al 200384 and Lin et al 200085 | |
| Osteotomy seems more effective to heal a metatarsal head DFU than conservative treatment (with or without offloading) alone | Low | Vanlerberghe et al 201481 | |
| Digital flexor tenotomy seems effective to heal a neuropathic plantar lesser digit apical DFU, but evidence from controlled studies is needed to confirm thisa | Low | Engels et al 2016,86 Tamir et al 2014,87 Rasmussen et al 2013,88 van Netten et al 2013,89 Kearney et al 2010,90 Schepers et al 2010,91 Tamir et al 2008,92 and Laborde et al 200793 | |
| Other DFU types | Nonremovable knee-high offloading devices seem effective to heal a neuropathic plantar forefoot DFU complicated by either mild infection or mild ischaemiaa | Low | Ha Van et al 201576 and Nabuurs-Franssen et al 200594 |
| Low | Ganguly et al 200857 | ||
| TCCs seem more effective than therapeutic footwear to heal a neuropathic plantar heel DFUa | |||
| SURROGATE | |||
| Plantar pressure | TCCs and removable knee-high offloading devices are equally effective in reducing peak pressure at the DFU location and forefoot and rearfoot areas. | Moderate | Gutekunst et al 2011,55 Gotz et al 2017,95 Armstrong et al 1999,96 Fleischli et al 1997,97 and Lavery et al 199698 |
| Removable knee-high offloading devices are more effective in reducing peak pressure at the DFU location and forefoot area than removable ankle-high offloading devices | Moderate | Bus et al 2018,16 Crews et al 2018,27 Westra et al 2018,46 Gotz et al 2017,95 Crews et al 2012,99 Nagel and Rosenbaum 2009,100 and Fleischli et al 199797 | |
| Removable ankle-high offloading devices seem more effective than conventional or standard therapeutic footwear in reducing plantar pressure at the DFU location and forefoot areas | Low | Crews et al 2018,27 Gotz et al 2017,95 Bus et al 2017,101 Crews et al 2012,99 Raspovic et al 2012,102 Bus et al 2009103 Bus et al 2009,104 Nagel and Rosenbaum 2009,100 and Fleischli et al 199797 | |
| Therapeutic footwear seems more effective than conventional footwear in reducing peak pressure at forefoot areas | Low | Viswanathan et al 2004,79 Nouman et al 2017,105 Lin et al 2013,106 Kavros et al 2011,107 Guldemond et al 2007,108 Praet et al 2003,109 Raspovic et al 2000,110 Lavery et al 1997,111 Lavery et al 1997,112 Lavery et al 1996,98 and Kato et al 1996113 | |
| Botulinum toxin injections are not superior to saline placebo injections for reducing plantar pressure at forefoot areas | Moderate | Hastings et al 201266 | |
| Felted foam applied to the forefoot with a cut out to the ulcer area seems more effective at reducing plantar pressure over 1 week compared with no felted foam | Low | Pabon-Carrasco et al 2016114 and Raspovic et al 201637 | |
| Achilles tendon lengthening in addition to a TCC seems more effective at reducing peak pressures at the forefoot in the short term than a TCC alone, but not in the long term, and at the expense of increases in rearfoot peak pressure. | Low | Maluf et al 200470 | |
| Ulcer area | TCCs and non-removable knee-high walkers are equally effective to reduce DFU area | Moderate | Piaggesi et al 201619 |
| Nonremovable knee-high offloading devices and removable knee-high offloading devices seem equally effective to reduce DFU area | Low | Najafi et al 2017,18 Piaggesi et al 2016,19 and Caravaggi et al 200759 | |
| Nonremovable knee-high offloading devices and removable ankle-high offloading devices seem equally effective to reduce DFU area | Low | Chakraborty et al 2015,54 Strakhova et al 2014,73 Faglia et al 2010,56 Van de Weg et al 2008,58 Agas et al 2006,74 and Udovichenko et al 200675 | |
| Removable knee-high offloading devices and removable ankle-high offloading devices are equally effective to reduce DFU area | Moderate | Bus et al 201816 and Johnson et al 201833 | |
| Felted foam attached to the foot (changed every 3 days) and worn in a removable ankle-high offloading device seems more effective to reduce DFU area than a removable ankle-high offloading device only | Low | Zimny et al 200368 | |
| Felted foam attached to the foot and worn in a removable ankle-high offloading device seems equally effective to reduce DFU area as attaching the felted foam to the insole of the removable ankle-high offloading device | Low | Nube et al 200667 | |
| Ambulatory activity | Nonremovable knee-high offloading devices and removable knee-high offloading devices seem to be associated with similar reductions in ambulatory activity | Low | Najafi et al 2017,18 Lavery et al 2015,34 and Armstrong et al 200163 |
| Nonremovable knee-high offloading devices are associated with a greater reduction in ambulatory activity than removable ankle-high offloading devices | Moderate | Lavery et al 201534 and Armstrong et al 200163 | |
| Removable knee-high offloading devices seem to be associated with greater reductions in ambulatory activity than removable ankle-high offloading devices | Low | Bus et al 2018,16 Lavery et al 2015,34 and Armstrong et al 200163 | |
| Adherence | Nonremovable knee-high offloading devices are associated with higher adherence than removable offloading devices. | Low | Lavery et al 201534 and Ha Van et al 200376 |
| Removable knee-high offloading devices and removable ankle-high devices seem to be associated with similar levels of adherence. | Low | Bus et al 201816 and Johnson et al 201833 | |
| SECONDARY | |||
| Adverse events | Nonremovable offloading devices and removable offloading devices seem to be associated with similar proportions of adverse events. | Low | Health Quality Ontario 2017,12 Lewis and Lipp 2013,52 Najafi et al 2017,18 Piaggesi et al 2016,19 Lavery et al 2015,34 Faglia et al 2010,56 Van de Weg et al 2008,58 Caravaggi et al 2007,59 Piaggesi et al 2007,60 Armstrong et al 2005,61 Katz et al 2005,62 and Armstrong et al 200163 |
| TCCs and non-removable knee-high walkers seem to be associated with similar proportions of adverse events | Low | Health Quality Ontario 2017,12 Piaggesi et al 2016,19 Piaggesi et al 2007,60 and Katz et al 200562 | |
| Removable knee-high and removable ankle-high offloading devices seem to be associated with similar proportions of adverse events. | Low | Health Quality Ontario 2017,12 Bus et al 2018,16 Lavery et al 2015,34 and Armstrong et al 200163 | |
| Nonremovable knee-high offloading devices and therapeutic footwear seem to be associated with similar proportions of adverse events. | Low | Health Quality Ontario 2017,12 Miyan et al 2014,36 Ganguly et al 2008,57 Caravaggi et al 2000,64 and Mueller et al 198965 | |
| Felted foam (with an aperture cut to the DFU location) attached to either the foot or the insole in a removable ankle-high offloading device (and changed every few days) seems to be associated with similar proportions of adverse events as only wearing a removable ankle-high offloading device | Low | Nube et al 200667 and Zimny et al 200368 | |
| Custom-made light-weight fibreglass heel cast in addition to usual care seems to be associated with similar proportions of adverse events as using usual care alone in patients with neuropathic rearfoot DFUa | Low | Jeffcoate et al 201717 | |
| Botulinum toxin injections and saline placebo injections seem to be associated with similar proportions of adverse events | Low | Hastings et al 201266 | |
| Achilles tendon lengthening in addition to a TCC seems to be associated with more adverse events (particularly new heel ulcers) than using a TCCs alone. | Low | Mueller et al 200371 | |
| Metatarsal head resection(s) in addition to non-surgical offloading interventions seems to be associated with fewer adverse events (particularly new infections) than non-surgical offloading alone in patients with neuropathic plantar metatarsal DFUa | Low | Kalantar Motamedi et al 2017,80 Armstrong et al 2012,82 Armstrong et al 2005,61 and Piaggesi et al 199872 | |
| Patient-reported outcomes | Nonremovable knee-high offloading devices, removable knee-high offloading devices, removable ankle-high offloading devices and therapeutic footwear seem to be associated with similar patient-reported outcomes. | Low | Piaggesi et al 2016,19 Lavery et al 2015,34 Piaggesi et al 2007,60 and Caravaggi et al 200064 |
| Custom-made light-weight fibreglass heel cast in addition to usual care seems to be associated with similar patient-reported outcomes as using usual care alone in patients with a neuropathic rearfoot DFUa | Low | Jeffcoate et al 201717 | |
| Metatarsal head resection(s) in addition to non-surgical offloading interventions seems to be associated with better patient-reported outcomes than non-surgical offloading alone in patients with neuropathic plantar metatarsal DFUa | Low | Piaggesi et al 199872 | |
| Cost-effectiveness | Nonremovable knee-high offloading devices seems to be more cost-effective than removable offloading devices in healing the DFU | Low | Health Quality Ontario 2017,12 Piaggesi et al 2016,19 and Faglia et al 201056 |
| Nonremovable knee-high walkers are more cost-effective than TCCs in healing the DFU | Moderate | Health Quality Ontario 2017,12 Piaggesi et al 201619 Piaggesi et al 2007,60 and Katz et al 200562 | |
| Removable knee-high walkers seem to be more cost-effective than therapeutic footwear in healing the DFU | Low | Health Quality Ontario 201712 | |
| Custom-made light-weight fibreglass heel cast in addition to usual care seems to be equally cost-effective as using usual care alone in patients with a neuropathic rearfoot DFUa | Low | Jeffcoate et al 201717 |
Abbreviations: DFU, diabetes-related foot ulcer; TCC, total contact cast.
a
Ulcer type that is not specifically a neuropathic plantar forefoot or midfoot ulcers in patients with diabetes.
b
Quality: Quality of the evidence.