Site-Specific, Critical Threshold Barefoot Peak Plantar Pressure Associated with Diabetic Foot Ulcer History: A Novel Approach to Determine DFU Risk in the Clinical Setting.

Background and Objectives: Barefoot peak plantar pressures (PPPs) are elevated in diabetes patients with neuropathic foot ulcer (DFU) history; however, there is limited reported evidence for a causative link between high barefoot PPP and DFU risk. We aimed to determine, using a simple mat-based methodology, the site-specific, barefoot PPP critical threshold that will identify a plantar site with a previous DFU. Materials and Methods: In a cross-sectional study, barefoot, site-specific PPPs were measured with normal gait for patients with DFU history (n = 21) and healthy controls (n = 12), using a validated carbon footprint system. For each participant, PPP was recorded at twelve distinct plantar sites (1st-5th toes, 1st-5th metatarsal heads (MTHs), midfoot and heel), per right and left foot, resulting in the analysis of n = 504 distinct plantar sites in the diabetes group, and n = 288 sites in the control group. Receiver operator characteristic curve analysis determined the optimal critical threshold for sites with DFU history. Results: Median PPPs for the groups were: diabetes sites with DFU history (n = 32) = 5.0 (3.25-7.5) kg/cm2, diabetes sites without DFU history (n = 472) = 3.25 (2.0-5.0) kg/cm2, control sites (n = 288) = 2.0 (2.0-3.25) kg/cm2; (p < 0.0001). Diabetes sites with elevated PPP (>6 kg/cm2) were six times more likely to have had DFU than diabetes sites with PPP ≤ 6 kg/cm2 (OR = 6.4 (2.8-14.6, 95% CI), p < 0.0001). PPP > 4.1 kg/cm2 was determined as the optimal critical threshold for identifying DFU at a specific plantar site, with sensitivity/specificity = 100%/79% at midfoot; 80%/65% at 5th metatarsal head; 73%/62% at combined midfoot/metatarsal head areas. Conclusions: We have demonstrated, for the first time, a strong, site-specific relationship between elevated barefoot PPP and previous DFU. We have determined a critical, highly-sensitive, barefoot PPP threshold value of >4.1 kg/cm2, which may be easily used to identify sites of previous DFU occurrence and, therefore, increased risk of re-ulceration. This site-specific approach may have implications for how high PPPs should be investigated in future trials.

The role of foot pressure measurement in the prediction and prevention of diabetic foot ulceration-A comprehensive review.

The predominant risk factor of diabetic foot ulcers (DFU), peripheral neuropathy, results in loss of protective sensation and is associated with abnormally high plantar pressures. DFU prevention strategies strive to reduce these high plantar pressures. Nevertheless, several constraints should be acknowledged regarding the research supporting the link between plantar pressure and DFUs, which may explain the low prediction ability reported in prospective studies. The majority of studies assess vertical, rather than shear, barefoot plantar pressure in laboratory-based environments, rather than during daily activity. Few studies investigated previous DFU location-specific pressure. Previous studies focus predominantly on walking, although studies monitoring activity suggest that more time is spent on other weight-bearing activities, where a lower "peak" plantar pressure might be applied over a longer duration. Although further research is needed, this may indicate that an expression of cumulative pressure applied over time could be a more relevant parameter than peak pressure. Studies indicated that providing pressure feedback might reduce plantar pressures, with an emerging potential use of smart technology, however, further research is required. Further pressure analyses, across all weight-bearing activities, referring to location-specific pressures are required to improve our understanding of pressures resulting in DFUs and improve effectiveness of interventions.

A peer-volunteer led active ageing programme to prevent decline in physical function in older people at risk of mobility disability (Active, Connected, Engaged [ACE]): study protocol for a randomised controlled trial.

BACKGROUND: The Active Connected Engaged [ACE] study is a multi-centre, pragmatic, two-arm, parallel-group randomised controlled trial [RCT] with an internal pilot phase. The ACE study incorporates a multi-level mixed methods process evaluation including a systems mapping approach and an economic evaluation. ACE aims to test the effectiveness and cost-effectiveness of a peer-volunteer led active ageing intervention designed to support older adults at risk of mobility disability to become more physically and socially active within their communities and to reduce or reverse, the progression of functional limitations associated with ageing. METHODS/DESIGN: Community-dwelling, older adults aged 65 years and older (n = 515), at risk of mobility disability due to reduced lower limb physical functioning (Short Physical Performance Battery (SPPB) score of 4-9 inclusive) will be recruited. Participants will be randomised to receive either a minimal control intervention or ACE, a 6-month programme underpinned by behaviour change theory, whereby peer volunteers are paired with participants and offer them individually tailored support to engage them in local physical and social activities to improve lower limb mobility and increase their physical activity. Outcome data will be collected at baseline, 6, 12 and 18 months. The primary outcome analysis (difference in SPPB score at 18 months) will be undertaken blinded to group allocation. Primary comparative analyses will be on an intention-to-treat (ITT) basis with due emphasis placed on confidence intervals. DISCUSSION: ACE is the largest, pragmatic, community-based randomised controlled trial in the UK to target this high-risk segment of the older population by mobilising community resources (peer volunteers). A programme that can successfully engage this population in sufficient activity to improve strength, coordination, balance and social connections would have a major impact on sustaining health and independence. ACE is also the first study of its kind to conduct a full economic and comprehensive process evaluation of this type of community-based intervention. If effective and cost-effective, the ACE intervention has strong potential to be implemented widely in the UK and elsewhere. TRIAL REGISTRATION: ISRCTN, ISRCTN17660493. Registered on 30 September 2021. Trial Sponsor: University of Birmingham, Contact: Dr Birgit Whitman, Head of Research Governance and Integrity; Email: researchgovernance@contacts.bham.ac.uk. Protocol Version 5 22/07/22.

An intelligent insole system with personalised digital feedback reduces foot pressures during daily life: An 18-month randomised controlled trial.

AIMS: High plantar pressure is a major risk factor in the development of diabetic foot ulcers (DFUs) and recent evidence shows plantar pressure feedback reduces DFU recurrence. This study investigated whether continued use of an intelligent insole system by patients at high-risk of DFUs causes a reduction in plantar pressures. METHODS: Forty-six patients with diabetic peripheral neuropathy and previous DFU were randomised to intervention (IG) or control groups (CG). Patients received an intelligent insole system, consisting of pressure-sensing insoles and digital watch. Patients wore the device during all daily activity for 18-months or until ulceration, and integrated pressure was recorded continuously. The device provided high-pressure feedback to IG only via audio-visual-vibrational alerts. High-pressure parameters at the whole foot, forefoot and rearfoot were compared between groups, with multilevel binary logistic regression analysis. RESULTS: CG experienced more high-pressure bouts over time than IG across all areas of the foot (P < 0.05). Differences between groups became apparent >16 weeks of wearing the device. CONCLUSIONS: Continuous plantar pressure feedback via an intelligent insole system reduces number of bouts of high-pressure in patients at high-risk of DFU. These findings suggest that patients were learning which activities generated high-pressure, and pre-emptively offloading to avoid further alerts.

Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study.

BACKGROUND: Prevention of diabetic foot ulcer recurrence in high risk patients, using current standard of care methods, remains a challenge. We hypothesised that an innovative intelligent insole system would be effective in reducing diabetic foot ulcer recurrence in such patients. METHODS: In this prospective, randomised, proof-of-concept study, patients with diabetes, and with peripheral neuropathy and a recent history of plantar foot ulceration were recruited from two multidisciplinary outpatient diabetic foot clinics in the UK, and were randomly assigned to either intervention or control. All patients received an insole system, which measured plantar pressure continuously during daily life. The intervention group received audiovisual alerts via a smartwatch linked to the insole system and offloading instructions when aberrant pressures were detected; the control group did not receive any alerts. The primary outcome was plantar foot ulcer occurrence within 18 months. This trial is registered with ISRCTN, ISRCTN05585501, and is closed to accrual and complete. FINDINGS: Between March 18, 2014, and Dec 20, 2016, 90 patients were recruited and consented to the study, and 58 completed the study. At follow-up, ten ulcers from 8638 person-days were recorded in the control group and four ulcers from 11 835 person-days in the intervention group: a 71% reduction in ulcer incidence in the intervention group compared with the control group (incidence rate ratio 0·29, 95% CI, 0·09-0·93; p=0·037). The number of patients who ulcerated was similar between groups (six of 26 [control group] vs four of 32 [intervention group]; p=0·29); however, individual plantar sites ulcerated more often in the control group (ten of 416) than in the intervention group (four of 512; p=0·047). In an exploratory analysis of good compliers (n=40), ulcer incidence was reduced by 86% in the intervention group versus control group (incidence rate ratio 0·14, 95% CI 0·03-0·63; p=0·011). In the exploratory analysis, plantar callus severity (change from baseline to 6 months) was greater in re-ulcerating patients (6·5, IQR 4·0-8·3) than non-re-ulcerating patients (2·0, 0·0-4·8; p=0·040). INTERPRETATION: To our knowledge, this study is the first to show that continuous plantar pressure monitoring and dynamic offloading guidance, provided by an innovative intelligent insole system, can lead to a reduction in diabetic foot ulcer site recurrence. FUNDING: Diabetes UK and Orpyx Medical Technologies.

A Foreign Body Through the Shoe of a Person With Diabetic Peripheral Neuropathy Alters Contralateral Biomechanics: Captured Through Innovative Plantar Pressure Technology.

High plantar pressure as a result of diabetic peripheral neuropathy is often reported as a major risk factor for ulceration. However, previous studies are confined to laboratories with equipment limited by cables, reducing the validity of measurements to daily life. The participant concerned in this case report was wearing an innovative plantar pressure feedback system as part of a wider study. The system allows for continuous plantar pressure monitoring and provides feedback throughout all activities of daily living. The participant concerned was a 59-year-old male with type 2 diabetes who presented with severe peripheral neuropathy. In addition, the right ankle had previously undergone fusion. Between monthly study appointments, the participant unknowingly had a screw embedded in his right shoe, while pressure was being recorded. Although no significant differences in pressure were present for the right foot with the embedded screw, the contralateral foot showed significantly higher pressure when the screw was embedded, compared with pre and post time periods. The increase in pressure on the contralateral foot is expected to result from the protrusion of the screw in the right shoe, causing a perturbation to balance and a shift in the center of pressure toward the contralateral side. This compensatory effect is likely to have been magnified by the limited mobility of the fused right ankle. These findings highlight the importance of checking both feet for ulcer risk, in the event of receiving high-pressure feedback. This innovative technology may improve our understanding of diabetic plantar foot ulcer development.

A New Mobile Application for Standardizing Diabetic Foot Images.

BACKGROUND: We describe the development of a new mobile app called "FootSnap," to standardize photographs of diabetic feet and test its reliability on different occasions and between different operators. METHODS: FootSnap was developed by a multidisciplinary team for use with the iPad. The plantar surface of 30 diabetic feet and 30 nondiabetic control feet were imaged using FootSnap on two separate occasions by two different operators. Reproducibility of foot images was determined using the Jaccard similarity index (JSI). RESULTS: High intra- and interoperator reliability was demonstrated with JSI values of 0.89-0.91 for diabetic feet and 0.93-0.94 for control feet. CONCLUSIONS: Similarly high reliability between groups indicates FootSnap is appropriate for longitudinal follow-ups in diabetic feet, with potential for monitoring pathology.