Capturing How the Accelerometer Measured Physical Activity Profile Differs in People with Diabetic Foot Ulceration.

Diabetic Foot Ulcers (DFUs) are a major complication of diabetes, with treatment requiring offloading. This study aimed to capture how the accelerometer-assessed physical activity profile differs in those with DFUs compared to those with diabetes but without ulceration (non-DFU). Participants were requested to wear an accelerometer on their non-dominant wrist for up to 8days. Physical activity outcomes included average acceleration (volume), intensity gradient (intensity distribution), the intensity of the most active sustained (continuous) 5-120 min of activity (MXCONT), and accumulated 5-120 min of activity (MXACC). A total of 595 participants (non-DFU = 561, DFU = 34) were included in the analysis. Average acceleration was lower in DFU participants compared to non-DFU participants (21.9 mg [95%CI:21.2, 22.7] vs. 16.9 mg [15.3, 18.8], p < 0.001). DFU participants also had a lower intensity gradient, indicating proportionally less time spent in higher-intensity activities. The relative difference between DFU and non-DFU participants was greater for sustained activity (MXCONT) than for accumulated (MXACC) activity. In conclusion, physical activity, particularly the intensity of sustained activity, is lower in those with DFUs compared to non-DFUs. This highlights the need for safe, offloaded modes of activity that contribute to an active lifestyle for people with DFUs.

A narrative review of the measurement methods for biomechanical properties of plantar soft tissue in patients with diabetic foot.

This article provides an overview of the development history and advantages and disadvantages of measurement methods for soft tissue properties of the plantar foot. The measurement of soft tissue properties is essential for understanding the biomechanical characteristics and function of the foot, as well as for designing and evaluating orthotic devices and footwear. Various methods have been developed to measure the properties of plantar soft tissues, including ultrasound imaging, indentation testing, magnetic resonance elastography, and shear wave elastography. Each method has its own strengths and limitations, and choosing the most appropriate method depends on the specific research or clinical objectives. This review aims to assist researchers and clinicians in selecting the most suitable measurement method for their specific needs.

Measuring 24-h use of time in people with a diabetes-related foot ulcer: A feasibility study.

BACKGROUND: Physical activity (PA), sleep and sedentary time are now recognised as mutually exclusive and exhaustive parts of the 24-h day-if PA decreases, time spent sleeping, being sedentary or both must increase so that all components equate to 24 h. Recent advances in time-use epidemiology suggest that we should not consider time-use domains (PA, sleep and sedentary time) in isolation from each other, but in terms of a composition-the mix of time-use domains across the 24-h day. While interrelated daily activities are known to be important in the management of diabetes mellitus, few studies have investigated the interrelated daily activities in people with an active diabetes-related foot ulcer (DFU) and their impact on important outcomes such as wound severity, blood glucose control and health-related quality of life (HRQoL). This feasibility study aims to determine the acceptability and practicality of measuring 24-h use of time data in people with a DFU and its associations on important outcome measures for this population. METHODS: Participants wore a wrist-worn accelerometer for two weeks and completed demographic and HRQoL questionnaires. Outcomes were participant engagement, reported levels of study burden and value and compositional data analysis as a methodological approach for evaluating 24-h use of time data. RESULTS: Twenty-six participants reported low levels of study burden and rated the study value highly. The protocol appears feasible in terms of recruitment (81%) and retention rate (86%). On average, participants were relatively sedentary spending 747, 172 and 18 min in sedentary time, light physical activity and moderate-to-vigorous activity, respectively. Sleep appeared adequate with participants obtaining an average of 485 min, but quality of sleep was notably poor with average sleep efficiency of 75%. Compositional data analysis was able to quantify the integrated associations of 24-h use of time with HRQoL. CONCLUSION: The protocol provides an acceptable method to collect 24-h use of time data in people with a DFU. Efforts to consider and analyse PA as part of a 24-h activity composition may provide holistic and realistic understandings of PA in this clinical population.

The impact of diabetes mellitus on foot perfusion measured by ICG NIR fluorescence imaging.

INTRODUCTION: Diabetes Mellitus (DM) is a common chronic disease, affecting 435 million people globally. Impaired vasculature in DM patients leads to complications like lower extremity arterial disease (LEAD) and foot ulcers, often resulting in amputations. DM causes additional peripheral neuropathy leading to multifactorial wound problems. Current diagnostics often deem unreliable, but Near-Infrared Fluorescence with Indocyanine Green (ICG NIR) can be used to assess the foot perfusion. Therefore, this study explores DM's impact on foot perfusion using ICG NIR. METHODS: Baseline ICG NIR fluorescence imaging was performed in LEAD patients with and without DM. Ten perfusion parameters were extracted and analyzed to assess differences in perfusion patterns. RESULTS: Among 109 patients (122 limbs) of the included patients, 32.8 % had DM. Six of ten perfusion parameters, mainly inflow-related, differed significantly between DM and non-DM patients (p-values 0.007-0.039). Fontaine stage 4 DM patients had the highest in- and outflow values, with seven parameters significantly higher (p-values 0.004-0.035). CONCLUSION: DM is associated with increased in- and outflow parameters. Patients with- and without DM should not be compared directly due to different vascular pathophysiology and multifactorial wound problems in DM patients. Quantified ICG NIR fluorescence imaging offers additional insight into the effect of DM on foot perfusion.

Current Opinion on Diagnosis of Peripheral Artery Disease in Diabetic Patients.

Peripheral arterial disease (PAD) prevalence and diabetes mellitus (DM) prevalence are continuously increasing worldwide. The strong relationship between DM and PAD is highlighted by recent evidence. PAD diagnosis in diabetic patients is very important, particularly in patients with diabetic foot disease (DFD); however, it is often made difficult by the characteristics of such diseases. Diagnosing PAD makes it possible to identify patients at a very high cardiovascular risk who require intensive treatment in terms of risk factor modification and medical therapy. The purpose of this review is to discuss the diagnostic methods that allow for a diagnosis of PAD in diabetic patients. Non-invasive tests that address PAD diagnosis will be discussed, such as the ankle-brachial index (ABI), toe pressure (TP), and transcutaneous oxygen pressure (TcPO2). Furthermore, imaging methods, such as duplex ultrasound (DUS), computed tomography angiography (CTA), magnetic resonance angiography (MRA), and digital subtraction angiography (DSA), are described because they allow for diagnosing the anatomical localization and severity of artery stenosis or occlusion in PAD. Non-invasive tests will also be discussed in terms of their ability to assess foot perfusion. Foot perfusion assessment is crucial in the diagnosis of critical limb ischemia (CLI), the most advanced PAD stage, particularly in DFD patients. The impacts of PAD diagnosis and CLI identification in diabetic patients are clinically relevant to prevent amputation and mortality.

Correlation of ankle-wrist pressure index with ankle-brachial pressure index to assess lower limb perfusion in diabetic foot ulcer: a pilot study.

OBJECTIVE: The presence of peripheral artery disease (PAD) in patients with diabetic foot ulcers (DFUs) is a significant risk factor for chronicity and amputation. Ankle-brachial pressure index (ABPI) is a screening tool for PAD. Brachial systolic pressure measurement, used as a denominator in the calculation of ABPI, produces inaccurate results in patients with obesity and the presence of heavy clothing. The wrist, however, is easily accessible, and the ankle-wrist pressure index (AWPI), if comparable with ABPI, may be useful in screening selected patients. This study aimed to assess the efficacy of AWPI in diagnosing perfusion in DFUs and compare it to ABPI in patients with DFUs. METHOD: ABPI and AWPI were calculated by measuring systolic blood pressure in the arteries of the ankle, arm and wrist with a handheld Doppler. Actual perfusion was determined by the presence or absence of PAD by duplex ultrasound. RESULTS: A total of 46 lower extremities in 41 patients were studied. The prevalence of PAD was 61%. Duplex ultrasound confirmed that the sensitivity of ABPI and AWPI in detecting PAD in patients with DFUs was 67.9% and 71.4% respectively, whereas the specificity of ABPI and AWPI was 94.4% and 88.9% respectively. On receiver operating characteristic analysis, the area under the curve of ABPI and AWPI was 0.804 and 0.795, respectively. A statistically significant positive correlation between ABPI and AWPI was found (r=0.986; p<0.001). CONCLUSION: There was a good correlation between ABPI and AWPI over a wide range of values. ABPI and AWPI may have a similar role in predicting perfusion in patients with DFUs. AWPI could be used in place of ABPI in selected patients in whom measuring ABPI may be difficult. DECLARATION OF INTEREST: The authors have no conflicts of interest to declare.

Undiagnosed and Untreated Peripheral Complications of Diabetes: Findings from a Pilot Study on Diabetes-Related Foot Diseases (DFD) in Patients with Glycemic Disorders.

BACKGROUND Diabetes-related foot disease (DFD) is a serious complication of diabetes, increasing the risk of amputation. Coimplications are preventable, but most diabetics do not receive proper screening and treatment, despite indications. This study was a pilot screening of diabetes-related foot disease in a group of people with glycemic disorders. MATERIAL AND METHODS We recruited 143 volunteers over 40 years of age. In the final analysis, we included 85 people diagnosed with glycemic disorders (diabetes or prediabetes), for whom we performed a total of 170 foot measurements. We screened for peripheral artery disease using: foot pulse, ankle-brachial index (manual and automatic), toe-brachial index, and transcutaneous oxygen pressure (TcPO2). To screen for diabetic peripheral neuropathy, we used indicators of loss of protective sensation: pressure perception and temperature perception, and plantar pressure distribution. RESULTS A history of diabetes was reported by 26 (30.6%) of the subjects. Disorders of at least 1 foot occurred in 20 (66.7%) subjects with diagnosed diabetes and in 10 (17%) subjects declaring no diabetes. Higher risk and DFD category were correlated with duration of diabetes (r=0.68, p=0.007), glycemic levels (r=0.56, p=0.001), age (r=0.57, p=0.007), and the presence of other diabetes complications. The best predictor of risk in DFD was manual ABI, p=0.001; followed by automatic ABI, p=0.006. CONCLUSIONS Our results showed that peripheral complications of diabetes, such as DFD, often remain undiagnosed and untreated despite the high risk of developing ulcers. There is a need for multi-center screening studies.

Plantar pressure reduction in the heel region through self-adjusting insoles with a heel cup in standard and individualized rocker shoes.

BACKGROUND: Effectiveness of therapeutic footwear in reducing peak pressure in persons with diabetes and loss of protective sensation to prevent diabetic foot ulcers varies due to manual production and possible changing foot structure. A previous two-way approach to address this issue, featuring individualized 3D-printed rocker midsoles and self-adjusting insoles, proved effective in the forefoot but less in the heel. To address this, new insoles incorporating a heel cup are developed. METHODS: In-shoe pressure was measured, while persons with diabetes and loss of protective sensation with high peak pressure (≥ 200 kPa) in the heel walked on a treadmill with control and individualized rocker shoe paired with control and new insole. FINDINGS: Generalized estimating equations revealed significant decrease in peak pressure in the proximal heel with the new insole alone and combined with rocker shoe compared to rocker shoe alone. For the distal heel, significant decrease in peak pressure is shown with the combination of new insole and rocker shoe compared to control shoe. For the forefoot and toes (excluding hallux) significant decrease in peak pressure is shown using the rocker shoe alone or combined with the heel cup compared to control shoe. INTERPRETATION: The new insole paired with rocker shoe is effective in reducing peak pressure in the distal heel. To have similar (or more) success in proximal heel, one could replace the rocker midsole with more compliant materials. The rocker shoe used separately or combined with a heel cup effectively reduces the peak pressure in the forefoot and other toes.

Dynamic Microcirculation Characteristics of Plantar Skin Under Metatarsal Head of Human Foot in Response to Life-Like Pressure Stimulus.

OBJECTIVE: Diabetic foot ulcer (DFU) is a severe complication with high mortality. High plantar pressure and poor microcirculation are considered main causes of DFU. The specific aims were to provide a novel technique for real-time measurement of plantar skin blood flow (SBF) under walking-like pressure stimulus and delineate the first plantar metatarsal head dynamic microcirculation characteristics because of life-like loading conditions in healthy individuals. METHODS: Twenty young healthy participants (14 male and 6 female) were recruited. The baseline (i.e., unloaded) SBF of soft tissue under the first metatarsal head were measured using laser Doppler flowmetry (LDF). A custom-made machine was utilized to replicate daily walking pressure exertion for 5 min. The exerted plantar force was adjusted from 10 N (127.3 kPa) to 40 N (509.3 kPa) at an increase of 5 N (63.7 kPa). Real-time SBF was acquired using the LDF. After each pressure exertion, postload SBF was measured for comparative purposes. Statistical analysis was performed using the R software. RESULTS: All levels of immediate-load and postload SBF increased significantly compared with baseline values. As the exerted load increased, the postload and immediate-load SBF tended to increase until the exerted load reached 35 N (445.6 kPa). However, in immediate-load data, the increasing trend tended to level off as the exerted pressure increased from 15 N (191.0 kPa) to 25 N (318.3 kPa). For postload and immediate-load SBF, they both peaked at 35 N (445.6 kPa). However, when the exerted force exceeds 35 N (445.6 kPa), both the immediate-load and postload SBF values started to decrease. CONCLUSIONS: Our study offered a novel real-time plantar soft tissue microcirculation measurement technique under dynamic conditions. For the first metatarsal head of healthy people, 20 N (254.6 kPa)-plantar pressure has a fair microcirculation stimulus compared with higher pressure. There might be a pressure threshold at 35 N (445.6 kPa) for the first metatarsal head, and soft tissue microcirculation may decrease when local pressure exceeds it.

[Evaluation of revascularization efficiency using near-infrared oximetry in patients with diabetic foot syndrome]. / Otsenka effektivnosti revaskulyarizatsii u patsientov s sindromom diabeticheskoi stopy metodom parainfrakrasnoi oksimetrii.

OBJECTIVE: To evaluate prognostic significance of tissue oximetry in healing of trophic defects in patients with diabetic foot syndrome (DFS) after endovascular revascularization. MATERIAL AND METHODS: In 42 patients with DFS, tissue oximetry was performed in angiosome projection with the FORE-SIGHT MC-2000 (CASMED) device before and the next day after revascularization of lower limb arteries. The 1st group included 30 patients with wound healing throughout 3 months, the 2nd group included 12 patients with amputation or no healing of trophic defects. RESULTS: Direct revascularization was more common in the 1st group (p=0.001). On the day after intervention, oxygen saturation (StO2) increased in all angiosomes in both groups (p<0.05). StO2 increment differed significantly between groups in all angiosomes except for point I (p<0.05). According to ROC analysis, StO2 increment by 4.5% in absolute values and 7.9% in percentage leads to trophic defect healing within 3 months (sensitivity and specificity were 76.7% and 66.7% for absolute values, 80% and 58.3% for percentage, respectively). CONCLUSION: Evaluation of StO2 in target angiosome may be valuable to predict trophic defect healing after endovascular surgery.

Correlation Between Pedal Acceleration Time and Transcutaneous Oxygen Pressures - A Prognostic Tool for Wound Healing in the Diabetic Foot Population.

BACKGROUND: Pedal arch interrogation by ultrasound through systolic acceleration time measurement (Pedal Acceleration Time [PAT]) is a recently described technique that offers valuable insights into foot hemodynamics. Previous studies have demonstrated a correlation between PAT and the ankle-brachial index and PAT has been proposed as a prognostic tool for wound healing in patients with peripheral artery disease. This study aims to assess the correlation between PAT and Transcutaneous Pressure of Oxygen (TcPO2) in the diabetic foot population. METHODS: In this single-center cross-sectional study PAT and TcPO2 were measured in diabetic patients with ischemic foot ulcers. The assessment of wound status was performed between the 12th and 16th week after the first evaluation. The primary outcome was to assess the correlation between the values obtained for PAT and TcPO2. The secondary outcome was to establish a cut-off value for wound healing. RESULTS: Sixty limbs with ischemic foot ulcers were evaluated. The results showed a correlation between PAT and TcPO2 [F (1.52) = 16.928; R2 = 0.246; P < 0.001]. The receiver operating characteristics curve analysis showed an optimal cut-off value at PAT >186 ms for predicting a nonhealing ulcer with a 96% specificity (area under the curve = 0.774; confidence interval 0.648-0.872; P < 0.001). CONCLUSIONS: PAT showed a significant correlation with TcPO2 with high specificity to identify nonhealing foot ulcers due to insufficient foot perfusion with a potential prognostic value in the diabetic foot population.

Wearable laser Doppler flowmetry for non-invasive assessment of diabetic foot microcirculation: methodological considerations and clinical implications.

Significance: Type 2 diabetes mellitus (T2DM) is a global health concern with significant implications for vascular health. The current evaluation methods cannot achieve effective, portable, and quantitative evaluation of foot microcirculation. Aim: We aim to use a wearable device laser Doppler flowmetry (LDF) to evaluate the foot microcirculation of T2DM patients at rest. Approach: Eleven T2DM patients and twelve healthy subjects participated in this study. The wearable LDF was used to measure the blood flows (BFs) for regions of the first metatarsal head (M1), fifth metatarsal head (M5), heel, and dorsal foot. Typical wavelet analysis was used to decompose the five individual control mechanisms: endothelial, neurogenic, myogenic, respiratory, and heart components. The mean BF and sample entropy (SE) were calculated, and the differences between diabetic patients and healthy adults and among the four regions were compared. Results: Diabetic patients showed significantly reduced mean BF in the neurogenic (p=0.044) and heart (p=0.001) components at the M1 and M5 regions (p=0.025) compared with healthy adults. Diabetic patients had significantly lower SE in the neurogenic (p=0.049) and myogenic (p=0.032) components at the M1 region, as well as in the endothelial (p<0.001) component at the M5 region and in the myogenic component at the dorsal foot (p=0.007), compared with healthy adults. The SE in the myogenic component at the dorsal foot was lower than at the M5 region (p=0.050) and heel area (p=0.041). Similarly, the SE in the heart component at the dorsal foot was lower than at the M5 region (p=0.017) and heel area (p=0.028) in diabetic patients. Conclusions: This study indicated the potential of using the novel wearable LDF device for tracking vascular complications and implementing targeted interventions in T2DM patients.

Effects of individually optimized rocker midsoles and self-adjusting insoles on dynamic stability in persons with diabetes mellitus and neuropathy.

BACKGROUND: Persons with diabetic peripheral neuropathy (DPN) may face challenges such as balance issues due to reduced somatosensory feedback and an increased risk of developing diabetic foot ulcers (DFUs) due to increased plantar pressure. Pressure reducing footwear is thought to further impair balance. We introduced 3D-printed rocker midsoles and self-adjusting insoles that are able to reduce elevated plantar pressure values and aimed to prevent balance deterioration. However, their effect on the balance during walking (dynamic stability) is not analyzed yet. RESEARCH QUESTION: Is dynamic stability of persons with DPN impaired compared to healthy individuals and what is the effect of the 3D-printed rocker midsoles and self-adjusting insoles on the dynamic stability in this population? METHODS: Dynamic stability, specifically the margins of stability (MOS) in the anterior-posterior (AP) and medio-lateral (ML) direction, was measured in ten healthy and nineteen persons with DPN. Independent-samples t-test was applied to analyze the difference in the MOS between groups. One-way repeated measures analyses of variance (ANOVA) was conducted to test the difference between the therapeutic footwear combinations within the DPN group. RESULTS: There is no significant difference between the healthy and DPN group in MOS-AP. MOS-ML is significantly larger in DPN compared to the healthy participants. Using the self-adjusting insole shows a significantly lower (negative) MOS-AP compared to when using a rocker shoe within the DPN group. SIGNIFICANCE: This study provides valuable information on whether DPN and our therapeutic footwear have a negative effect on the dynamic stability. DPN does not have a negative effect on dynamic stability in the AP direction. For the ML direction, DPN seems to cause larger MOS-ML by likely using a compensation strategy (e.g., wider steps) while our experimental footwear does not further impair the MOS-ML.

Factors Influencing Wound Healing in Diabetic Foot Patients.

Background and objectives: Diabetic foot stands out as one of the most consequential and devastating complications of diabetes. Many factors, including VIPS (Vascular management, Infection management, Pressure relief, and Source of healing), influence the prognosis and treatment of diabetic foot patients. There are many studies on VIPS, but relatively few studies on "sources of healing". Nutrients that affect wound healing are known, but objective data in diabetic foot patients are insufficient. We hypothesized that "sources of healing" would have many effects on wound healing. The purpose of this study is to know the affecting factors related to the source of healing for diabetic foot patients. Materials and Methods: A retrospective review identified 46 consecutive patients who were admitted for diabetic foot management from July 2019 to April 2021 at our department. Several laboratory tests were performed for influencing factor evaluation. We checked serum levels of total protein, albumin, vitamin B, iron, zinc, magnesium, copper, Hb, HbA1c, HDL cholesterol, and LDL cholesterol. These values of diabetic foot patients were compared with normal values. Patients were divided into two groups based on wound healing rate, age, length of hospital stay, and sex, and the test values between the groups were compared. Results: Levels of albumin (37%) and Hb (89%) were low in the diabetic foot patients. As for trace elements, levels of iron (97%) and zinc (95%) were low in the patients, but levels of magnesium and copper were usually normal or high. There were no differences in demographic characteristics based on wound healing rate. However, when compared to normal adult values, diabetic foot patients in our data exhibited significantly lower levels of hemoglobin, total protein, albumin, iron, zinc, copper, and HDL cholesterol. When compared based on age and length of hospital stay, hemoglobin levels were significantly lower in both the older age group and the group with longer hospital stays. Conclusions: Serum levels of albumin, Hb, iron, and zinc were very low in most diabetic foot patients. These low values may have a negative relationship with wound healing. Nutrient replacements are necessary for wound healing in diabetic foot patients.

Treating chronic wounds in an acute care setting: the forgotten diagnosis.

BACKGROUND: Chronic wounds include lower extremity ulcers, diabetic foot ulcers, and pressure injuries, and can take months or years to heal. Wounds place a high burden on outpatient and inpatient care settings. This burden is expected to increase markedly in the United States as the population ages and with increased rates of diabetes, obesity, and COVID-19. PURPOSE: To articulate the effect of chronic, hard-to-heal wounds on acute care facilities, and how a few days of inpatient care can have a significant effect on the healing trajectory. METHODS: An expert panel of 7 members, all with extensive knowledge and experience in the assessment and treatment of chronic wounds in an acute care setting, was convened in March 2022. The panel discussed the role of hospitals as part of the longer-term healing pathway of chronic wounds. RESULTS: Chronic wounds have a significant effect on hospitals that includes unseen costs, bed occupancy, demands on bedside nurses, and wound complications that lead to extended stays or readmissions. A successful inpatient wound program offers appropriate identification of previously undiagnosed wounds, elevation of bedside care through simplified protocols, quickly and easily understood education and easy dressing selection, and comprehensive discharge planning with a multidisciplinary team for continuity of care and reduced risk of readmission. CONCLUSION: Hospitals can play a key role in the management of chronic wounds, thus reducing the effect on each facility and the wider care network.

An observational study of the pH value during the healing process of diabetic foot ulcer.

OBJECTIVE: In this study, we evaluated the pH (potential of hydrogen) value of diabetic foot ulcers and explored the relationship between the pH value and infection, sinus formation, stasis dermatitis, and the process of healing. METHODS: From October 2022 to June 2023, 99 patients with 106 diabetic foot ulcers were selected. Diabetic foot ulcers were treated in a standardized manner by a professional team. The pH value, area, PUSH (Pressure Ulcer Scale for Healing) score, and the degree of infection of the wounds were compared before and after the treatment. RESULTS: The baseline wound pH value in 76.4% of the patients was in the alkaline range and was closely related to the degree of infection (P < 0.05). As the ulcers healed, the pH decreased. For moderately and severely infected diabetic foot ulcers, each unit decrease in pH was associated with a decrease in the PUSH score of approximately 4.6 points (P < 0.05). The pH values of wounds with surrounding ecchymosis dermatitis were significantly higher than those of wounds without ecchymosis dermatitis (P < 0.05). The pH value of the wound with a sinus tract was higher. After treatment, there was no significant difference in pH value between the patients with and without sinus tracts (P < 0.05). CONCLUSIONS: The measurement of pH value is efficient and simple, and the patient suffers no discomfort in the process. The change in pH helps predict the healing process of diabetic foot ulcers and quickly identify whether there are key factors such as infection and ischemia in the wound. It is suggested that dynamic pH monitoring be included in the whole course evaluation and intervention strategy development of diabetic foot.

Plantar pressure measurement in diabetic foot disease: A scoping review.

AIMS/INTRODUCTION: Patients with a healed diabetic foot ulcer (DFU) have a 40% risk of ulcer recurrence within a year. New and effective measures to prevent DFU recurrence are essential. We aimed to highlight emerging trends and future research opportunities in the use of plantar pressure measurement to prevent DFU recurrence. MATERIALS AND METHODS: Our scoping review protocol was drafted using the Preferred Reporting Items for Systematic Reviews and Meta-analysis - Scoping Review protocol. Peer-reviewed, English-language papers were included that addressed both plantar pressure measurement and diabetic foot disease, either as primary studies that have advanced the field or as review papers that provide summaries and/or opinion on the field as a whole, as well as specific papers that provide guidelines for future research and advancement in the field. RESULTS: A total of 24 eligible publications were identified in a literature search using PubMed. A further 36 eligible studies were included after searching the references sections of these publications, leaving a total of 60 publications included in this scoping review. CONCLUSIONS: Plantar pressure measurement can and will play a major role in the prevention of DFU. There is already a strong, albeit limited, evidence base in place to prove its benefit in reducing DFU recurrence. More research is required in larger populations, using remote monitoring in real-world settings, and with improved technology.

Initial handgrip strength as a predictive factor for amputation risk in diabetic foot patients.

BACKGROUND: We aimed to analyze the prognostic significance of handgrip strength as predictor of lower extremity amputation at 1 year follow up in patients with type 2 diabetes. METHODS: We evaluated 526 patients with type 2 diabetes between August 2020, and, June 2022. We collected from the electronic medical records demographic variables, laboratory data and history of amputation. The handgrip strength was assessed using a handheld Smedley digital dynamometer following the NHANES Muscle Strenght/Grip Test Procedure. Low handgrip strength was defined for women as less than 16 kg and for men less than 27 kg. Outcome variable was major or minor lower extremity amputation. RESULTS: A total of 205 patients with complete data entered the study. Patients mean age was 59 years old, 37% were women and the mean diabetes disease duration was 14 years. Seventy-seven (37%) patients suffered from lower extremity mputations (26 major and 51 minor amputations). After controlling for age, gender, presence of peripheral artery disease, body mass index and white cell counts as confounder variables, patients with low handgrip had an increased risk for amputations (Odds Ratio 2.17; 95% confidence Interval: 1.09-4.32; <0.001). CONCLUSION: Low handgrip stregth is an independent prognostic marker for lower limb amputation at one year in patients with diabetes.

The Stress of Measuring Plantar Tissue Stress in People with Diabetes-Related Foot Ulcers: Biomechanical and Feasibility Findings from Two Prospective Cohort Studies.

Reducing high mechanical stress is imperative to heal diabetes-related foot ulcers. We explored the association of cumulative plantar tissue stress (CPTS) and plantar foot ulcer healing, and the feasibility of measuring CPTS, in two prospective cohort studies (Australia (AU) and The Netherlands (NL)). Both studies used multiple sensors to measure factors to determine CPTS: plantar pressures, weight-bearing activities, and adherence to offloading treatments, with thermal stress response also measured to estimate shear stress in the AU-study. The primary outcome was ulcer healing at 12 weeks. Twenty-five participants were recruited: 13 in the AU-study and 12 in the NL-study. CPTS data were complete for five participants (38%) at baseline and one (8%) during follow-up in the AU-study, and one (8%) at baseline and zero (0%) during follow-up in the NL-study. Reasons for low completion at baseline were technical issues (AU-study: 31%, NL-study: 50%), non-adherent participants (15% and 8%) or combinations (15% and 33%); and at follow-up refusal of participants (62% and 25%). These underpowered findings showed that CPTS was non-significantly lower in people who healed compared with non-healed people (457 [117; 727], 679 [312; 1327] MPa·s/day). Current feasibility of CPTS seems low, given technical challenges and non-adherence, which may reflect the burden of treating diabetes-related foot ulcers.

A Method for Diabetic Wound-Specific Insole Design, Manufacturing, and Biomechanical Validation for Better Recovery.

BACKGROUND: Muscle disorders may cause a change in plantar pressures by the misalignment on the foot during gait phases. Therefore, corns or calluses develop at the plantar regions, and diabetic foot ulcers follow for severe cases, although it can be prevented and even treated by podiatric approaches with patient-specific therapeutic insoles and footwear. Although the importance of a threshold value of 200 kPa in peak plantar pressure reduction has been highlighted as a standard to prevent reulceration in the diabetic foot, it may not be possible to ensure this pressure reduction for each patient. METHODS: In this study, three types of ethylene-vinyl acetate have been used to optimize the off-loading performance for predetermined early-stage diabetic foot ulcer scenarios by means of baropodometric plantar pressure analyses and finite element method for each gait phase. RESULTS: The total cost of the manufacturing for this study was reduced to $10.26 and it was performed in 24.6 minutes. In addition, the off-loaded pressure was increased by 2.3 times and the volume of the off-loading geometry was increased 8.12 times based on the foam polymer used. CONCLUSIONS: Consequently, improved off-loading was obtained and a standard was proposed for the first time to calculate the off-loading performance before manufacturing of the therapeutic insole model to ensure a better recovery period.