Effectiveness of offloading interventions for people with diabetes-related foot ulcers: A systematic review and meta-analysis.

BACKGROUND: Offloading treatment is crucial to heal diabetes-related foot ulcers (DFU). This systematic review aimed to assess the effectiveness of offloading interventions for people with DFU. METHODS: We searched PubMed, EMBASE, Cochrane databases, and trials registries for all studies relating to offloading interventions in people with DFU to address 14 clinical question comparisons. Outcomes included ulcers healed, plantar pressure, weight-bearing activity, adherence, new lesions, falls, infections, amputations, quality of life, costs, cost-effectiveness, balance, and sustained healing. Included controlled studies were independently assessed for risk of bias and had key data extracted. Meta-analyses were performed when outcome data from studies could be pooled. Evidence statements were developed using the GRADE approach when outcome data existed. RESULTS: From 19,923 studies screened, 194 eligible studies were identified (47 controlled, 147 non-controlled), 35 meta-analyses performed, and 128 evidence statements developed. We found non-removable offloading devices likely increase ulcers healed compared to removable offloading devices (risk ratio [RR] 1.24, 95% CI 1.09-1.41; N = 14, n = 1083), and may increase adherence, cost-effectiveness and decrease infections, but may increase new lesions. Removable knee-high offloading devices may make little difference to ulcers healed compared to removable ankle-high offloading devices (RR 1.00, 0.86-1.16; N = 6, n = 439), but may decrease plantar pressure and adherence. Any offloading device may increase ulcers healed (RR 1.39, 0.89-2.18; N = 5, n = 235) and cost-effectiveness compared to therapeutic footwear and may decrease plantar pressure and infections. Digital flexor tenotomies with offloading devices likely increase ulcers healed (RR 2.43, 1.05-5.59; N = 1, n = 16) and sustained healing compared to devices alone, and may decrease plantar pressure and infections, but may increase new transfer lesions. Achilles tendon lengthening with offloading devices likely increase ulcers healed (RR 1.10, 0.97-1.27; N = 1, n = 64) and sustained healing compared to devices alone, but likely increase new heel ulcers. CONCLUSIONS: Non-removable offloading devices are likely superior to all other offloading interventions to heal most plantar DFU. Digital flexor tenotomies and Achilles tendon lengthening in combination with offloading devices are likely superior for some specific plantar DFU locations. Otherwise, any offloading device is probably superior to therapeutic footwear and other non-surgical offloading interventions to heal most plantar DFU. However, all these interventions have low-to-moderate certainty of evidence supporting their outcomes and more high-quality trials are needed to improve our certainty for the effectiveness of most offloading interventions.

Sub-calcaneal plantar fat pad assessment using dual-energy computed tomography: First experience in the diabetic foot.

BACKGROUND: This study assessed the use of dual-energy computed tomography (CT) to evaluate sub-calcaneal plantar fat pad changes in people with diabetic neuropathy. METHODS: Dual-energy CT scans of people with diabetic neuropathy and non-diabetic controls were retrospectively included. Average CT values (in Hounsfield Units) and thickness (in centimeters) of the sub-calcaneal plantar fat pad were measured in mono-energetic images at two energy levels (40 keV and 70 keV). The CT values measured in patients with diabetic neuropathy were correlated to barefoot plantar pressure measurements performed during walking in a clinical setting. FINDINGS: Forty-five dual-energy CT scans of people with diabetic neuropathy and eleven DECT scans of non-diabetic controls were included. Mean sub-calcaneal plantar fat pad thickness did not significantly differ between groups (diabetes group 1.20 ± 0.34 cm vs. control group 1.21 ± 0.28 cm, P = 0.585). CT values at both 40 keV (-34.7 ± 48.7 HU vs. -76.0 ± 42.8 HU, P = 0.013) and 70 keV (-11.2 ± 30.8 HU vs. -36.3 ± 27.2 HU, P = 0.017) were significantly higher in the diabetes group compared to controls, thus contained less fatty tissue. This elevation was most apparent in patients with Type 1 diabetes. CT values positively correlated with the mean peak plantar pressure. INTERPRETATION: Dual-energy CT was able to detect changes in the plantar fat pad of people with diabetic neuropathy.

The efficacy of flexor tenotomy to prevent recurrent diabetic foot ulcers (DIAFLEX trial): Study protocol for a randomized controlled trial.

Foot ulcers are a frequent and costly problem in people with diabetes mellitus and can lead to amputations. Prevention of these ulcers is therefore of paramount importance. Claw/hammer toe deformities are commonly seen in people with diabetes. These deformities increase the risk of ulcer development specifically at the (tip of) the toe. Percutaneous needle tenotomy of the tendon of the m. flexor digitorum longus (tendon tenotomy) can be used to reduce the severity of claw/hammer toe deformity with the goal to prevent ulcer recurrence. The main objective of this randomized controlled trial is to assess the efficacy of flexor tenotomy to prevent recurrence of toe ulcers in people with diabetes and a history of toe (pre-)ulcers. Additionally, we aim to assess interphalangeal joints (IPJ) and metatarsophalangeal joint (MTPJ) angles in a weight-bearing and non-weight-bearing position, barefoot plantar pressure during walking, cost-effectiveness and quality of life before and after the intervention and compare intervention and control study groups. Sixty-six subjects with diabetes and claw/hammer toe deformity and a recent history of (pre-)ulceration on the tip of the toe will be included and randomized between flexor tenotomy of claw/hammer toes (intervention) versus standard of care including orthosis and shoe offloading (controls) in a mono-center randomized controlled trial. Clinicaltrialsgov registration: NCT05228340.

Preliminary evaluation of dual-energy CT to quantitatively assess bone marrow edema in patients with diabetic foot ulcers and suspected osteomyelitis.

OBJECTIVES: The purpose of this study is to evaluate the value of dual-energy CT (DECT) with virtual non-calcium (VNCa) in quantitatively assessing the presence of bone marrow edema (BME) in patients with diabetic foot ulcers and suspected osteomyelitis. METHODS: Patients with a diabetic foot ulcer and suspected osteomyelitis that underwent DECT (80 kVp/Sn150 kVp) with VNCa were retrospectively included. Two observers independently measured CT values of the bone adjacent to the ulcer and a reference bone not related to the ulcer. The patients were divided into two clinical groups, osteomyelitis or no-osteomyelitis, based on the final diagnosis by the treating physicians. RESULTS: A total of 56 foot ulcers were identified of which 23 were included in the osteomyelitis group. The mean CT value at the ulcer location was significantly higher in the osteomyelitis group (- 17.23 ± 34.96 HU) compared to the no-osteomyelitis group (- 69.34 ± 49.40 HU; p < 0.001). Within the osteomyelitis group, the difference between affected bone and reference bone was statistically significant (p < 0.001), which was not the case in the group without osteomyelitis (p = 0.052). The observer agreement was good for affected bone measurements (ICC = 0.858) and moderate for reference bone measurements (ICC = 0.675). With a cut-off value of - 40.1 HU, sensitivity was 87.0%, specificity was 72.7%, PPV was 69.0%, and NPV was 88.9%. CONCLUSION: DECT with VNCa has a potential value for quantitatively assessing the presence of BME in patients with diabetic foot ulcers and suspected osteomyelitis. KEY POINTS: • Dual-energy CT (DECT) with virtual non-calcium (VNCa) is promising for detecting bone marrow edema in the case of diabetic foot ulcers with suspected osteomyelitis. • DECT with VNCa has the potential to become a more practical alternative to MRI in assessing the presence of bone marrow edema in suspected osteomyelitis when radiographs are not sufficient to form a diagnosis.

Metatarsophalangeal and interphalangeal joint angle measurements on weight-bearing CT images.

BACKGROUND: The aim of this study was to present and evaluate methods of measuring toe joint angels using joint-surface based and inertial axes approaches. METHODS: Nine scans of one frozen human cadaveric foot were obtained using weight-bearing CT. Two observers independently segmented bones in the forefoot and measured metatarsalphalangeal joint (MTPJ) angles, proximal and distal interphalangeal joint (PIPJ and DIPJ) angles and interphalangeal angles of the hallux (IPJ) using 1) inertial axes, representing the long anatomical axes, of the bones and 2) axes determined using centroids of articular joint surfaces. RESULTS: The standard deviations (SD) of the IPJ/PIPJ and DIPJ angles were lower using joint-surface based axes (between 1.5˚ and 4.1˚) than when the inertial axes method was used (between 3.3˚ and 16.4˚), for MTPJ the SD's were similar for both methods (between 0.5˚ and 2.6˚). For the IPJ/PIPJ and DIPJ angles, the width of the 95% CI and the range were also lower using the joint-surface axes method (95% CI: 2.0˚-4.1˚ vs 3.2˚-16.3˚; range: 3.1˚-7.4˚ vs 3.8˚-35.8˚). Intra-class correlation coefficients (ICC) representing inter- and intra-rater reliability were good to excellent regarding the MTPJ and IPJ/PIPJ angles in both techniques (between 0.85 and 0.99). For DIPJ angles, ICC's were good for the inertial axes method (0.78 and 0.79) and moderate for the joint-surface axes method (0.60 and 0.70). CONCLUSION: The joint-surface axes method enables reliable and reproducible measurements of MTPJ, IPJ/PIPJ and DIPJ angles. For PIPJ and DIPJ angles this method is preferable over the use of inertial axes.

Adherence to at-Home Monitoring of Foot Temperatures in People with Diabetes at High Risk of Ulceration.

We aimed to investigate adherence to at-home monitoring of foot temperature and its association with patient-, disease- and behavior-related factors, in people with diabetes at high risk of ulceration. We analyzed 151 participants in the enhanced therapy arm of the DIATEMP trial (all at high diabetes-related foot ulcer risk) who aimed to perform and log foot temperatures daily for 18 months or until ulceration. Adherence was the proportion of measurement days covered (PDC), with being adherent defined as PDC≥70%. If a hotspot was recorded, adherence to subsequently reducing ambulatory activity was assessed. Multivariate logistic regression analysis was performed to investigate associations with adherence. We found ninety-four participants (62.3%) adherent to measuring foot temperatures. This was higher in months 1-3 versus months 4-18: 118 (78.1%) versus 78 (57.4%; P < .001). Of 83 participants with a hotspot, 24 (28.9%) reduced ambulatory activity. Increasing age (P = .021, OR = 1.045) and better self-care (P = .007, OR = 1.513) were positively associated with adherence to measuring foot temperature. In conclusion, in people at high diabetes-related foot ulcer risk, adherence to measuring foot temperature was high in the first months after study commencing, but dropped over time. Adherence to reducing ambulatory activity when a hotspot was found was low over the entire study period.

Clinical outcome of CIDP one year after start of treatment: a prospective cohort study.

OBJECTIVE: To assess clinical outcome in treatment-naive patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). METHODS: We included adult treatment-naive patients participating in the prospective International CIDP Outcome Study (ICOS) that fulfilled the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) diagnostic criteria for CIDP. Patients were grouped based on initial treatment with (1) intravenous immunoglobulin (IVIg), (2) corticosteroid monotherapy or (3) IVIg and corticosteroids (combination treatment). Outcome measures included the inflammatory Rasch-built overall disability scale (I-RODS), grip strength, and Medical Research Council (MRC) sum score. Treatment response, treatment status, remissions (improved and untreated), treatment changes, and residual symptoms or deficits were assessed at 1 year. RESULTS: Forty patients were included of whom 18 (45%) initially received IVIg, 6 (15%) corticosteroids, and 16 (40%) combination treatment. Improvement on ≥ 1 of the outcome measures was seen in 31 (78%) patients. At 1 year, 19 (48%) patients were still treated and fourteen (36%) patients were in remission. Improvement was seen most frequently in patients started on IVIg (94%) and remission in those started on combination treatment (44%). Differences between groups did not reach statistical significance. Residual symptoms or deficits ranged from 25% for neuropathic pain to 96% for any sensory deficit. CONCLUSIONS: Improvement was seen in most patients. One year after the start of treatment, more than half of the patients were untreated and around one-third in remission. Residual symptoms and deficits were common regardless of treatment.

Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in chronic inflammatory demyelinating polyradiculoneuropathy: protocol of an international, randomised, double-blind, placebo-controlled trial (OPTIC).

BACKGROUND: International guidelines recommend either intravenous immunoglobulin (IVIg) or corticosteroids as first-line treatment for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). IVIg treatment usually leads to rapid improvement and is generally safe, but does not seem to lead to long-term remissions. Corticosteroids act more slowly and are associated with more side effects, but may induce long-term remissions. The hypothesis of this study is that combined IVIg and corticosteroid induction treatment will lead to more frequent long-term remissions than IVIg treatment alone. METHODS: An international, randomised, double-blind, placebo-controlled trial, in adults with 'probable' or 'definite' CIDP according to the EFNS/PNS 2010 criteria. Three groups of patients are included: (1) treatment naïve, (2) known CIDP patients with a relapse after > 1 year without treatment, and (3) patients with CIDP who improved within 3 months after a single course of IVIg, who subsequently deteriorate at any interval without having received additional treatment. Patients are randomised to receive 7 courses of IVIg and 1000 mg intravenous methylprednisolone (IVMP) (in sodium chloride 0.9%) or IVIg and placebo (sodium chloride 0.9%), every 3 weeks for 18 weeks. IVIg treatment consists of a loading dose of 2 g/kg (over 3-5 days) followed by 6 courses of IVIg 1/g/kg (over 1-2 days). The primary outcome is remission at 1 year, defined as improvement in disability from baseline, sustained between week 18 and week 52 without further treatment. Secondary outcomes include changes in disability, impairment, pain, fatigue, quality of life, care use and costs and (long-term) safety. DISCUSSION: In case of superiority of the combined treatment, patients will experience the advantages of two proven efficacious treatments, namely rapid improvement due to IVIg and long-term remission due to corticosteroids. Long-term remission would reduce the need for maintenance IVIg treatment and may decrease health care costs. Additionally, we expect that the combined treatment leads to a higher proportion of patients with improvement as some patients who do not respond to IVIg will respond to corticosteroids. Risks of short and long-term additional adverse events of the combined treatment need to be assessed. TRIAL REGISTRATION: ISRCTN registry ISRCTN15893334 . Prospectively registered on 12 February 2018.

Foot ulcer recurrence, plantar pressure and footwear adherence in people with diabetes and Charcot midfoot deformity: A cohort analysis.

AIMS: To investigate people with Charcot midfoot deformity with regard to plantar pressure, footwear adherence and plantar foot ulcer recurrence. METHODS: Twenty people with diabetes, Charcot midfoot deformity, plantar foot ulcer history and custom-made footwear were assessed with regard to barefoot and in-shoe plantar pressures during walking, footwear adherence (% of daily steps over 7-day period) and plantar foot ulcer recurrence over 18 months. In a cohort design, they were compared to 118 people without Charcot foot (non-Charcot foot group) with custom-made footwear and similar ulcer risk factors. RESULTS: Median (interquartile range) barefoot midfoot peak pressures were significantly higher in the Charcot foot group than in the non-Charcot foot group [756 (260-1267) vs 146 (100-208) kPa; P<0.001]. In-shoe midfoot peak pressures were not significantly higher in the Charcot foot group [median (interquartile range) 152 (104-201) vs 119 (94-160) kPa] and significantly lower for all other foot regions. Participants in the Charcot foot group were significantly more adherent, especially at home, than participants in the non-Charcot foot group [median (interquartile range) 94.4 (85.4-95.0)% vs. 64.3 (25.4-85.7)%; P=0.001]. Ulcers recurred in 40% of the Charcot foot group and in 47% of the non-Charcot foot group (P=0.63); midfoot ulcers recurred significantly more in the Charcot foot group (4/8) than in the non-Charcot foot group (1/55; P=0.001). CONCLUSIONS: Effective offloading and very high footwear adherence were found in people with diabetes and Charcot midfoot deformity. While this may help protect against plantar foot ulcer recurrence, a large proportion of such people still experience ulcer recurrence. Further improvements in adherence and custom-made footwear design may be required to improve clinical outcome.

Combined intravenous immunoglobulin and methylprednisolone as induction treatment in chronic inflammatory demyelinating polyneuropathy (OPTIC protocol): a prospective pilot study.

BACKGROUND AND PURPOSE: We hypothesized that combining intravenous immunoglobulin (IVIg) and intravenous methylprednisolone (IVMP) leads to more frequent remission compared with IVIg alone while maintaining the fast efficacy of IVIg. In this uncontrolled pilot study, we evaluated remission, rate of improvement and safety in patients with chronic inflammatory demyelinating polyradiculoneuropathy receiving induction treatment with combined IVIg and IVMP. METHODS: Consecutive treatment-naive patients with chronic inflammatory demyelinating polyradiculoneuropathy were treated with IVIg infusions, consisting of a 2 g/kg loading dose and 1 g/kg maintenance treatment every 3 weeks, combined with 3-weekly 1-g IVMP infusions, for a total of 18 weeks. The cumulative steroid dose was 7 g. Primary outcome was remission at 1 year in patients who completed the treatment schedule. Remission was defined as improvement at 18 weeks without the need for further immune treatment between end of the treatment schedule and 1-year follow-up. Improvement was defined as a minimal clinically important difference on the Inflammatory Rasch-Built Overall Disability Scale and/or an increase of ≥8 kPa in grip strength between baseline and week 18. RESULTS: A total of 20 patients were included; 17 completed the treatment schedule. A total of 13 (76%) of these patients improved at 18 weeks after start of treatment and 10 (59%) patients were in remission at 1 year. Serious adverse events were found in four patients. CONCLUSIONS: Short-term combined induction treatment with IVIg and IVMP induced remission in almost 60% of patients who completed the treatment schedule. Combined induction therapy was generally well tolerated. A randomized controlled trial is currently running to confirm efficacy and safety of IVMP as add-on treatment to IVIg.

An evaluation of our experience in position verification of catheters used for interstitial high-dose-rate brachytherapy of solitary bladder tumors.

PURPOSE: The goal of this study was to verify the position of catheters used over 4 days for brachytherapy of solitary bladder tumors. METHODS AND MATERIALS: The study covered three phases. Shifting of catheters was studied using daily position verification CT scans of 20 patients. The possibility to omit the CT scan on Day 2 by adding a loading margin of 4 mm on each side was studied using data of 5 patients. Whether the Day 4 verification CT scan could be omitted if this margin was used, was studied for another group of 10 patients, comparing the Day 3 treatment plan to the Day 4 CT scan. RESULTS: An average catheter shift on Days 2, 3, and 4 of, respectively, -0.3 mm (-8 to 10 mm), -0.5 mm (-14 to 10 mm), and -0.1 mm (-16 to 28 mm) was found over the measurements at both sites of the catheter. Including only shifts causing underdosing of the clinical target volume (CTV), the average shift on Days 2, 3, and 4 was, respectively, -3.6 mm (-1 to -8 mm), -5.4 mm (-1 to -14 mm), and -5.3 mm (-1 to -16 mm). After adding a loading margin, the CTV was covered on Day 2; however, the margin was not sufficient for Days 3 and 4. On Day 4, in 2/10 patients, the CTV was not completely covered. In 5/10 patients, an increased 200% isodose volume was found. CONCLUSIONS: Position verification is necessary in bladder brachytherapy. If a 4-mm margin on each side of the loading pattern was added, position verification on Day 2 could be omitted. The verification CT scan of Days 3 and 4 is still necessary.

Prevention of foot ulcers in the at-risk patient with diabetes: a systematic review.

BACKGROUND: Prevention of foot ulcers in patients with diabetes is extremely important to help reduce the enormous burden of foot ulceration on both patient and health resources. A comprehensive analysis of reported interventions is not currently available, but is needed to better inform caregivers about effective prevention. The aim of this systematic review is to investigate the effectiveness of interventions to prevent first and recurrent foot ulcers in persons with diabetes who are at risk for ulceration. METHODS: The available medical scientific literature in PubMed, EMBASE, CINAHL and the Cochrane database was searched for original research studies on preventative interventions. Both controlled and non-controlled studies were selected. Data from controlled studies were assessed for methodological quality by two independent reviewers. RESULTS: From the identified records, a total of 30 controlled studies (of which 19 RCTs) and another 44 non-controlled studies were assessed and described. Few controlled studies, of generally low to moderate quality, were identified on the prevention of a first foot ulcer. For the prevention of recurrent plantar foot ulcers, multiple RCTs with low risk of bias show the benefit for the use of daily foot skin temperature measurements and consequent preventative actions, as well as for therapeutic footwear that demonstrates to relieve plantar pressure and that is worn by the patient. To prevent recurrence, some evidence exists for integrated foot care when it includes a combination of professional foot treatment, therapeutic footwear and patient education; for just a single session of patient education, no evidence exists. Surgical interventions can be effective in selected patients, but the evidence base is small. CONCLUSION: The evidence base to support the use of specific self-management and footwear interventions for the prevention of recurrent plantar foot ulcers is quite strong, but is small for the use of other, sometimes widely applied, interventions and is practically nonexistent for the prevention of a first foot ulcer and non-plantar foot ulcer.

Footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in patients with diabetes: a systematic review.

BACKGROUND: Footwear and offloading techniques are commonly used in clinical practice for preventing and healing of foot ulcers in persons with diabetes. The goal of this systematic review is to assess the medical scientific literature on this topic to better inform clinical practice about effective treatment. METHODS: We searched the medical scientific literature indexed in PubMed, EMBASE, CINAHL, and the Cochrane database for original research studies published since 1 May 2006 related to four groups of interventions: (1) casting; (2) footwear; (3) surgical offloading; and (4) other offloading interventions. Primary outcomes were ulcer prevention, ulcer healing, and pressure reduction. We reviewed both controlled and non-controlled studies. Controlled studies were assessed for methodological quality, and extracted key data was presented in evidence and risk of bias tables. Uncontrolled studies were assessed and summarized on a narrative basis. Outcomes are presented and discussed in conjunction with data from our previous systematic review covering the literature from before 1 May 2006. RESULTS: We included two systematic reviews and meta-analyses, 32 randomized controlled trials, 15 other controlled studies, and another 127 non-controlled studies. Several randomized controlled trials with low risk of bias show the efficacy of therapeutic footwear that demonstrates to relief plantar pressure and is worn by the patient, in the prevention of plantar foot ulcer recurrence. Two meta-analyses show non-removable offloading to be more effective than removable offloading for healing plantar neuropathic forefoot ulcers. Due to the limited number of controlled studies, clear evidence on the efficacy of surgical offloading and felted foam is not yet available. Interestingly, surgical offloading seems more effective in preventing than in healing ulcers. A number of controlled and uncontrolled studies show that plantar pressure can be reduced by several conservative and surgical approaches. CONCLUSIONS: Sufficient evidence of good quality supports the use of non-removable offloading to heal plantar neuropathic forefoot ulcers and therapeutic footwear with demonstrated pressure relief that is worn by the patient to prevent plantar foot ulcer recurrence. The evidence base to support the use of other offloading interventions is still limited and of variable quality. The evidence for the use of interventions to prevent a first foot ulcer or heal ischemic, infected, non-plantar, or proximal foot ulcers is practically non-existent. High-quality controlled studies are needed in these areas.

Innovations in plantar pressure and foot temperature measurements in diabetes.

Plantar pressure and temperature measurements in the diabetic foot primarily contribute to identifying abnormal values that increase risk for foot ulceration, and they are becoming increasingly more integrated in clinical practice and daily life of the patient. While plantar pressure measurements have long been present, only recently evidence shows their importance in ulcer prevention, as a data-driven approach to therapeutic footwear provision. The long-term monitoring of plantar pressures with the option to provide feedback, when alarming pressure levels occur, is a promising development in this area, although more technical and clinical validation is required. Shear is considered important in ulcer aetiology but is technically difficult to measure. Innovative research is underway to assess if foot temperature can act as a useful surrogate for shear. Because the skin heats up before it breaks down, frequent monitoring of foot temperature can identify these warning signals. This approach has shown to be effective in preventing foot ulcers. Innovation in diagnostic methods for foot temperature monitoring and evidence on cost effectiveness will likely facilitate implementation. Finally, monitoring of adherence to offloading treatment using temperature-based sensors has proven to be a feasible and relevant method with a wide range of possible research and patient care applications. These innovations in plantar pressure and temperature measurements illustrate an important transfer in diabetic foot care from subjective to objective evaluation of the high-risk patient. They demonstrate clinical value and a large potential in helping to reduce the patient and economic burden of diabetic foot disease.

Data-driven directions for effective footwear provision for the high-risk diabetic foot.

AIMS: Custom-made footwear is used to offload the diabetic foot to prevent plantar foot ulcers. This prospective study evaluates the offloading effects of modifying custom-made footwear and aims to provide data-driven directions for the provision of effectively offloading footwear in clinical practice. METHODS: Eighty-five people with diabetic neuropathy and a recently healed plantar foot ulcer, who participated in a clinical trial on footwear effectiveness, had their custom-made footwear evaluated with in-shoe plantar pressure measurements at three-monthly intervals. Footwear was modified when peak pressure was ≥ 200 kPa. The effect of single and combined footwear modifications on in-shoe peak pressure at these high-pressure target locations was assessed. RESULTS: All footwear modifications significantly reduced peak pressure at the target locations compared with pre-modification levels (range -6.7% to -24.0%, P < 0.001). The metatarsal heads were most frequently targeted. Repositioning an existing (trans-)metatarsal pad in the shoe insole (-15.9% peak pressure relief), applying local cushioning to the insole (-15.0%) and replacing the insole top cover with Plastazote (-14.2%) were the most effective single modifications. Combining a new Plastazote top cover with a trans-metatarsal bar (-24.0% peak pressure relief) or with local cushioning (-22.0%) were the most effective combined modifications. CONCLUSIONS: In people with diabetic neuropathy and a recently healed plantar foot ulcer, significant offloading can be achieved at high-risk foot regions by modifying custom-made footwear. These results provide data-driven directions for the design and evaluation of custom-made footwear for high-risk people with diabetes, and essentially mean that each shoe prescribed should incorporate those design features that effectively offload the foot.

The value of reporting pressure-time integral data in addition to peak pressure data in studies on the diabetic foot: a systematic review.

BACKGROUND: In plantar pressure studies on the diabetic foot, pressure-time integral data is often analyzed and reported next to peak pressure data, mostly because of its assumed additional value. The aim was to assess this additional value by systematically reviewing the relevant literature. METHODS: The MEDLINE database was searched for original articles that report both pressure-time integral and peak pressure data measured in the diabetic foot. Eligible articles were assessed according to differences in reported results between both parameters, the quality of discussion and specific conclusions drawn on pressure-time integral data, and the added value of the pressure-time integral data. FINDINGS: All 35 eligible papers described studies on gait. Differences in reported results between parameters were found to be clear, minimal, or absent in 15, 8, and 12 papers, respectively. In 15 papers, the pressure-time integral results were discussed with respect to the peak pressure results, but in only 5 papers the explanation given for reported differences was considered meaningful. Specific conclusions were drawn in 11 papers. Some added value was found in 10 papers, but in all papers one or more limitations to this value applied. INTERPRETATION: The study findings suggest that the added value of reporting pressure-time integral data is limited. Unless clear benefit can be shown such, as that ulceration can be better predicted using pressure-time integral than using peak pressure data, the reporting of pressure-time integral data seems redundant to express the plantar loading in the diabetic foot.

Biceps brachii can add to performance of tasks requiring supination in cerebral palsy patients.

The aim of this study was to assess whether cerebral palsy patients can use biceps brachii for supination during movement tasks requiring supination and pronation. 3D upper extremity kinematic and EMG-data of 12 patients (mean age 13 y 8 mo ± 36 mo) were compared to 10 healthy age-matched controls. Significant difference in biceps brachii activation between maximal isolated pronation and supination in both groups showed that it is possible for CP patients to use biceps brachii for supination. Performance of reach-to-grasp with either pronation or supination showed similar activation patterns as during isolated tasks in both groups, although increased biceps brachii activation likely also hampered performance of reach-to-grasp in the patient group by causing increased, and possibly unwanted elbow flexion. However, the functional effect of this flexion for supination purposes cannot be ruled out. Therefore, one should be cautious with simply weakening biceps brachii when the purpose is to improve functional reach. Ideally treatment might focus more on changing the flexion moment/supination moment ratio of biceps toward a stronger supination function.

Offloading effect of therapeutic footwear in patients with diabetic neuropathy at high risk for plantar foot ulceration.

AIMS: Custom-made therapeutic footwear is often prescribed to patients with diabetic neuropathy, foot deformity and a healed plantar foot ulcer. Offloading these feet is important to prevent ulcer recurrence. The aim was to evaluate the offloading effect of custom-made footwear in these patients. METHODS: In 171 patients with diabetic neuropathy (336 feet) with foot deformity and a recently healed plantar foot ulcer, plantar pressures walking barefoot and inside new custom-made footwear were measured. At the previous ulcer location and at locations of highest barefoot pressure attributable to the deformity, in-shoe pressures were compared with non-deformed feet. The footwear was considered effective in offloading when in-shoe peak pressure at these locations was < 200 kPa. RESULTS: Mean in-shoe peak pressures ranged between 211 and 308 kPa in feet with forefoot deformity (vs. 191-222 kPa in non-deformed feet) and between 140 and 187 kPa in feet with midfoot deformity (vs. 112 kPa in non-deformed feet). Offloading was effective in 61% of all feet with deformity, 81% of feet with midfoot deformity, 44% of feet with forefoot deformity and 62% of previous ulcer locations. Inter-subject variability in measured in-shoe plantar pressure was large. CONCLUSIONS: Offloading in custom-made footwear is often not sufficiently achieved in high-risk diabetic feet with deformity. Highest offloading success rates were seen at known high-risk locations such as previous ulcer locations and Charcot feet, the lowest success rates in forefoot deformities. Together with the large inter-subject variability in pressure outcomes, this emphasizes the need for evidence-based prescription and evaluation procedures to assure adequate offloading.