A comparison of customised and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: a participant-blinded randomised controlled trial.

UNLABELLED: BACKGROUND: Neuropathic diabetic foot ulceration may be prevented if the mechanical stress transmitted to the plantar tissues is reduced. Insole therapy is one practical method commonly used to reduce plantar loads and ulceration risk. The type of insole best suited to achieve this is unknown. This trial compared custom-made functional insoles with prefabricated insoles to reduce risk factors for ulceration of neuropathic diabetic feet. METHOD: A participant-blinded randomised controlled trial recruited 119 neuropathic participants with diabetes who were randomly allocated to custom-made functional or prefabricated insoles. Data were collected at issue and six month follow-up using the F-scan in-shoe pressure measurement system. Primary outcomes were: peak pressure, forefoot pressure time integral, total contact area, forefoot rate of load, duration of load as a percentage of stance. Secondary outcomes were patient perceived foot health (Bristol Foot Score), quality of life (Audit of Diabetes Dependent Quality of Life). We also assessed cost of supply and fitting. Analysis was by intention-to-treat. RESULTS: There were no differences between insoles in peak pressure, or three of the other four kinetic measures. The custom-made functional insole was slightly more effective than the prefabricated insole in reducing forefoot pressure time integral at issue (27% vs. 22%), remained more effective at six month follow-up (30% vs. 24%, p=0.001), but was more expensive (UK £656 vs. £554, p<0.001). Full compliance (minimum wear 7 hours a day 7 days per week) was reported by 40% of participants and 76% of participants reported a minimum wear of 5 hours a day 5 days per week. There was no difference in patient perception between insoles. CONCLUSION: The custom-made insoles are more expensive than prefabricated insoles evaluated in this trial and no better in reducing peak pressure. We recommend that where clinically appropriate, the more cost effective prefabricated insole should be considered for use by patients with diabetes and neuropathy. TRIAL REGISTRATION: Clinical trials.gov (NCT00999635). Note: this trial was registered on completion

Standardization and First Lessons Learned of the Prototype HB650 Cryomodule for PIP-II at Fermilab

International audienceThe prototype High Beta 650 MHz cryomodule (pHB650 CM) has been designed by an integrated design team, consisting of Fermilab (USA), CEA (France), STFC UKRI (UK), and RRCAT (India). The manufacturing and assembly of this prototype cryomodule is being done at Fermilab, whereas the production cryomodules will be manufactured and assembled by STFC-UKRI. As the first PIP-II cryomodule for which standardization was applied, the design, manufacturing and assembly of this cryomodule led to significant lessons being learnt and experiences gathered. These were incorporated into the design of the pre-production Single Spoke Resonator Type 2 cryomodule (ppSSR2 CM) and the pre-production Low Beta 650 MHz cryomodule (ppLB650 CM). This paper presents the pHB650 CM lessons learned and experiences gathered from the design to the lower coldmass assembly and how this cryomodule has a positive impact on all the next Proton Improvement Plan-II (PIP-II) cryomodules due to the standardization set up among SSR and 650 cryomodules