Background
Methods
Search strategy
Eligibility criteria
Quality assessment
Results
Author, date | Location | Study design | Follow up period | Sample size | Sample characteristics | Intervention & Comparison | Outcome measures | Result |
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Arts et al. 2012 [38] | Netherlands | Repeated measures | Same day | 171 (336 ft) | Diabetic neuropathy Previous plantar ulcer | Custom-made footwear Semi-customised footwear Barefoot | Peak plantar pressure (PPP) of < 200 kPa considered successful | Custom-made footwear is least effective in pressure reduction (< 200 KPa) at forefoot compared to midfoot and known ulcer locations (29% vs 81 and 62%) |
Arts et al. 2015 [39] | Netherlands | Repeated measures | Same day | 85 | Diabetic neuropathy Previous plantar foot ulcer | Various footwear modifications to custom or semi-custom footwear Footwear before modification | % plantar pressure reduction | MP, local cushion and plastazote top cover reduce PP respectively by15.9, 15, 14.2% and combinedly 24 and 22% at the forefoot. |
Bus et al. 2011 [30] | Netherlands | Repeated measures | Not reported | 23 | Diabetic Neuropathy, Foot deformity Foot ulcer | Fully custom-made footwear and insoles | In-shoe plantar pressure reduction by more than 25% (Criteria A) or below the absolute value of 200 kPa (Criteria B) | MB or MP, replacing the top cover, early rocker can reduce pressure at hallux and metatarsal area ranging from 10.1 to18.6% as an individual modification. |
Bus et al. 2004 [40] | Netherlands | Repeated measure | Not reported | 20 | Diabetic Neuropathy, History of healed plantar foot ulcers Foot deformity | Insoles; 9.5 mm thick flat PPT insole and custom-made insoles out of open-cell urethane foams of hardness 60–80. Custom-made insoles were made by CADCAM process. | Plantar pressure reduction FTI | Custom-made insoles reduce plantar pressure and FTI significantly at medial and lateral heal, MTH1 and FTI at lateral MTHs when compared with flat PPT insoles. |
Charanya et al. 2004 [41] | India | Case-control study | 6 months | 25 | Diabetic Neuropathy History of active and healed plantar ulcers Non-diabetic (Control) | Footwear with an insole made of 12 mm MCR, shore value 200, Toughened rocker profile rubber outsole | Foot sole hardness reduced close to normal, shore value 200 | Plantar ulcers healed in three-four weeks, foot sole skin hardness reduced to 25–30 from 45 to 50 shore values. |
Netherlands | Repeated measures | Not reported | 17 | Diabetic Neuropathy Higher barefoot plantar pressure (≥700 kPa) | Insole with various height arch supports and with and without a metatarsal dome | In-shoe plantar pressure reduction (36% & 39%), Walking convenience on a 10-point rating scale | Extra arch support and MD are respectively effective in 39% & 36% pressure reduction in central and medial regions of the forefoot | |
Hastings et al. 2007 [44] | USA | Repeated measure | 22 months | 20 | Diabetic Neuropathy History of plantar foot ulcers No active foot ulcers No Charcot neuropathy | Three footwear conditions; extra depth footwear with 1) Total Contact Insoles (TCI), 2) TCI with proximal Metatarsal Pad (MP), 3) TCI with distal MP, CT Scan | PPP CT Scan for positioning of MP against MTHs | Highest (57%) PPP reduction occurred at 2nd MTH when MP placed at 10.6 mm proximal to MTH line. Variable PPP under the 2nd MTH varied between 32 ± 16% when positioning of MP varies between 6.1 mm to 10.6 mm proximal to MTH line. |
Lin et al. 2013 [45] | China | Repeated measure | Not reported | 26 | Diabetic Neuropathy | Insole with pre-plug removal, post-plug removal, and post-plug removal + arch support | Mean peak pressure (MPP), maximum force, contact area | Removing insole plug is effective in offloading MPP by 32.3% and adding arch support reduces further 9.5% at the forefoot |
Lott et al. 2006 [46] | USA | Repeated measure | Not reported | 20 | Diabetic Neuropathy History of midfoot or forefoot plantar ulcers | Four different conditions; 1) Barefoot, 2) Footwear, 3) Footwear + TCI, 4) Footwear + TCI + MP | Plantar pressure reduction Soft tissue thickness (STT) | PP & ST strain under 2nd MTH are highest at the barefoot condition and lowest at footwear + TCI + MP condition. Mean PP for all four conditions under 2nd MTH is 272 kPa, 173 kPa, 140 kPa and 98 kPa. |
Martinez-Santos et al. 2019 [47] | UK | Repeated measure | Not reported | 60 | Diabetic Neuropathy No previous ulcers | Insole with three different metatarsal bar (MB) positioning, two different types of materials | PPP | Maximum pressure reduction can be achieved by positioning metatarsal bar at 72% length of insole, irrespective of material type |
Mueller et al. 2006 [48] | USA | Repeated measure | Not reported | 20 | Diabetic Neuropathy history of plantar ulcers | Three footwear conditions: 1) Footwear, 2) Footwear with TCI, and 3) Footwear with TCI + MP | PPP PTI STT | TCI and metatarsal pad caused reductions of pressure under the metatarsal heads |
Owings et al. 2008 [49] | USA | Repeated measure | Not reported | 20 | Diabetic Neuropathy Higher (> 750 kPa) barefoot plantar pressure at MTH region | Three different type custom-made insoles (X, Y from shape-based and Z combined foot shape with plantar pressure data). Footwear with rigid rocker sole and flexible sole | Peak pressure FTI | Shape and pressure-based insoles (Z) showed improved offloading by 32 and 21%, PTI reduction 40 and 34% when compared to shape-only-based insoles (X-Polypropylene base, Y- EVA base). A similar trend was observed in flexible and rocker bottom shoes for the same insoles. |
Paton et al. 2012 [50] | UK | RCT | 18 months | 119 | Neuropathic diabetic foot ulceration | Prefabricated and custom-made insole | In-shoe pressure reduction, PTI, forefoot rate of load, total contact area | Prefab versus custom insoles, PPP ≥ 6%, |
Praet et al. 2003 [51] | Netherlands | Repeated measure | Not reported | 10 | Diabetic Neuropathy No active ulcer, No major foot deformities | Three different types of footwear designs | Peak pressure reduction at multiple areas under the foot | Rocker sole can offload the forefoot area by 65% |
Preece et al. 2017 [52] | UK | Case-control | Not reported | 168 | Diabetic Neuropathy (n = 17) Healthy control (N = 66) | Eight types of rocker sole design | Pressure reduction threshold of ≤200 kPa | Rocker apex position at 52%, 200 rocker angle, 950 apex angle yields effective offloading at most |
Tang et al. 2014 [53] | Sweden | RCT | Two years | 114 | Diabetic neuropathy Angiopathy Foot deformities Previous ulcers or amputation | Three types of insoles, custom made (35 & 55° shore hardness EVA) vs prefab insoles with hardcore EVA + soft microfiber top cover (Control) | PPP PTI | The overall PPP for the insoles was between 180 kPa to 211 kPa, PTI differences 14 kPa/sec & 20 kPa/sec with Control. |
Teffler et al. 2017 [54] | UK | Randomised crossover | Not reported | 20 | Diabetic neuropathy Increased forefoot plantar pressure No Charcot foot or partial amputation | Three types of insoles 1) Standard (Shape-based), milled insoles, 2) Milled, virtually optimised insoles and 3) 3D printed virtually optimised insoles | PPP | Virtually optimised insole reduced PPP by a mean of 41.3 kPa for milled and 40.5 kPa for 3D printed insoles in the same participants’ group. |
Tsung et al. 2004 [55] | China | Case-control | Not reported | 14 | Diabetic neuropathy No Charcot foot or partial amputation Control: no foot deformity | Five support conditions including footwear-only, flat insoles; and three custom-made insoles with three weight-bearing conditions; 1) Full weight-bearing (FWB), 2) Semi-weight-bearing (SWB) and 3) Non-weight-bearing (NWB) | MPP PTI Mean contact area | For 2–3 MTH regions, SWB insoles yield maximum offloading comparing to two other insoles type. For MTH1, NWB insoles provide maximum offloading. FWB insoles show maximum PTI comparing to NWB & SWB conditions. NWB insoles provide maximum arch support and contoured shaped insoles. |
Author, date | Location | Study design | Follow up period | Sample size | Sample characteristics | Intervention & Comparison | Outcome measures | Result |
---|---|---|---|---|---|---|---|---|
Busch et al. 2003 [56] | Germany | Prospective cohort | Up to 42 months | 92 | Diabetes Neuropathy Peripheral vascular disease (PVD) | Lucro SDS vs non-SDS standard footwear | Ulcer recurrence | Annual ulcer recurrence SDS 15% vs Non-SDS 60% when severe foot deformity is non-existent |
Bus et al. 2013 [57] | Netherlands | RCT | 18 months | 171 | Diabetes Neuropathy Healed plantar ulcers | Custom-made footwear with and without modifications based on in-shoe pressure analysis | Ulcer recurrence Adherence of ≥80% steps taken | Modified custom-made footwear are only useful in offloading forefoot area if they are worn as per advised (Adherence ≥80%) |
Chantelau et al. 1990 [58] | Germany | Prospective cohort | 25 months | 50 | Diabetes Neuropathy PVD History of healed plantar foot ulcer Partial or forefoot amputation | Custom-made footwear with rocker soles and custom-made insoles with 10 mm thickness, | Ulcer recurrence Adherence (regular vs irregular wearing of footwear and insoles) | Regular wearing of footwear and insoles reduced the relative risk of foot ulceration to 0.48 (95% confidence interval 0.29 to 0.79), compared with irregular wearing |
Lavery et al. 2012 [59] | USA | RCT | 18 months | 299 | Diabetes Neuropathy Healed foot ulcers Foot deformity | Shear reducing insole (SRI) with standard therapy group (STG) with therapeutic footwear, diabetic foot education and care | Ulcer recurrence | SRI group were 3.5 times less likely to develop foot ulcers comparing to the STG group. No significant difference in the frequency of footwear and insole usage in SRI or STG group. |
López-Moral et al. 2019 [60] | Italy | RCT | 18 months | 51 | Diabetes Neuropathy Healed plantar ulcers | Semi-rigid (control) and rigid rocker sole (test) therapeutic footwear | Ulcer recurrence Adherence > 60% | Rigid rocker sole can reduce risk of re-ulceration at forefoot by 64% compared to semi-rigid rocker sole |
Rizzo et al. 2012 [61] | Italy | RCT | 5 years | 298 | Diabetes Neuropathy Healed plantar foot ulcer Minor amputation | Standard comfort footwear vs custom insoles and footwear as per Dahmen et al. algorithm | Ulcer recurrence | Ulcer recurrence rates in 1, 3 & 5 years are 11.5% vs 38.6, 17.6% vs 61, 23.5% vs 72% where forefoot deformities are predominant among the participants. |
Ulbrecht et al. 2014 [62] | USA | RCT | 15 months | 150 | Diabetes Neuropathy Healed plantar foot ulcer (MTHs) Increased barefoot plantar pressure | Control: Standard custom-made insoles from three different suppliers Experimental: Insoles made according to the protocol in Owings et al. 2008. | Ulcerative or non-ulcerative lesions at the plantar forefoot in MTHs regions | Foot shape and plantar pressure-based custom insoles provide superior offloading than insoles made from foot shape and clinical insights. |