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Effectiveness of a new brand of stock 'diabetic' shoes to protect against diabetic foot ulcer relapse. A prospective cohort study.

AIMS: Diabetic patients with podopathy (diabetic foot syndrome) may need protective footwear, be it customized or industrially produced stock 'diabetic' shoes (SDS). The effectiveness of each type of 'diabetic' shoe needs to be proven clinically, e.g. in terms of prevention of foot ulceration. The following study assesses a new German SDS, the LucRo shoe, which consists of rocker-shaped walking sole, a standardized shock absorption insole, and soft uppers without stiff toe-caps. The LucRo SDS has been registered as a Medicinal Product according to the European Community Guideline 93/42/EC. PATIENTS AND METHODS: A total of 92 high-risk diabetic patients (mean age 63 years, duration of diabetes 13 years) with healed foot ulcer were recruited prospectively over 31 months; 87 patients suffered from polyneuropathy, 24 patients had peripheral ischaemic vessel disease. One group of patients (n = 60) received the LucRo SDS and wore them, while the remaining patients (n = 32) did not receive the SDS and were forced to use their normal footwear. This allocation reflects the haphazard reimbursement policies of the individual patients' health insurance, and is in accordance with the current German legislation. The patients were followed up for up to 42 months until the first foot ulcer relapse, or the end of the study. RESULTS: There were no differences between the groups concerning age, sex, type and duration of diabetes, prevalence of polyneuropathy and peripheral ischaemic vessel disease, frequency of foot care and mortality rate. The first year annual rate of foot ulcer relapse was significantly different between the groups: 60% without SDS vs. 15% with SDS. The overall cumulative ulcer-free survival was significantly greater with SDS (P < 0.0001, log rank test). CONCLUSION: The LucRo stock 'diabetic' shoe appears effective in the prevention of foot re-ulceration in high-risk patients with diabetic podopathy.

Aged↗

Pressure distribution measurements for evaluation of running shoe properties.

The loading of individual foot structures which may play an important role in the occurrence of overuse injuries can be determined by using pressure distribution devices. In-shoe pressure measurements are of special interest as they provide information about the changes in foot to ground interactions with footwear modifications. Several studies have investigated the magnitudes of plantar in-shoe pressures at different running velocities. The first ray of the foot, composed of first metatarsus and hallux, was identified as one of the main load bearing structures during the push-off phase. Low correlations were found for the relationships of plantar pressures to ground reaction force or shock related variables. Pressure measurements provide a unique insight into the interaction between the human body, footwear and the ground. Substantial differences can be found in the peak pressure and relative load patterns due to different shoe constructions. It was also shown that plantar pressure measurement can be employed to identify changes of footwear properties with use. Although in-shoe pressure data offer detailed information about the loading behavior of the foot in various activities, at present conclusions for medical implications are still speculative.

Athletic Injuries↗

[Biomechanical and orthopedic problems of tennis and indoor sports shoe].

In contrast to running, a large number of indoor sports show a variety of body and foot movements with fast changes of direction. These "stop-and-go" movements (including jumps and rotations) produce loads at the joints of the foot, knee and hip in an order of magnitude often underestimated. The goal of this investigation was to provide an overview over various indoor sports movements and to draw conclusions with respect to sport shoe constructions. Reconsideration of the functionality of the foot led to shoe constructions which allow the shoe to rotate about its longitudinal axis (torsion), a movement with which the forefoot can again "reach" for the ground in landing situations. However, the problem of the rear foot stability and cushioning at a rear foot touch down is not yet solved. Therefore it must be postulated that shoes for indoor sports and tennis should be provided with an increased lateral stability at the rear foot.

Athletic Injuries↗

[Criteria for running (jogging) shoe tests].

Shoes for jogging are presently being tested by a great many institutes using widely divergent criteria and according to a plethora of different interests, and hence the assessments and test results may be poles apart and even contradictory. Most of the tests are based on much too short stress periods and either disregard biomechanical properties entirely or determine them via methods that must be classified as questionable. Today no manufacturer offers models one could definitely classify as excellent or deficient. A shoe for jogging may be optimal for one jogger and fatal for another. The following article sets criteria yielding two important kinds of information: on the one hand, an analysis of weak points that will help the manufacturer by telling him where he must improve his product, and on the other hand target-group oriented usage recommendations for the benefit of the consumer (jogger) that help him to find the shoe that suits him best among a never-ending conglomerate of sports shoes.

Adult↗

[Pressure distribution on the sole of the human foot while standing and walking, barefoot and with shoes].

For more than a century, scientists and practicians of orthopedic shoe production have been increasing their knowledge on the normal statics and dynamics of the lower extremities as well as on innate or often acquired posture anomalies and foot deformities. Even amongst young adults, barely half of one percent has so-called "inconspicuous" feet without restrictive signs of foot deformities. Consequently, the resulting primary illnesses and secondary injuries must be treated. Quantitative pressure distribution graphs in isobaric representation at the heel barefoot when standing and walking were determined by means of an improved, locally fixed device by Elftman and Helm. For the first time, a newly developed mobile measuring process allows measuring pressures at the heel inside the shoe while standing as well as while walking, running or jumping. The rolloff motion of the heel allowed the determination of a "maximum pressure line." Orthopedic recommendations for the production of true-to-form and true-to-function shoes for walking and sports shoes are included.

Biomechanical Phenomena↗

Can custom-made biomechanic shoe orthoses prevent problems in the back and lower extremities? A randomized, controlled intervention trial of 146 military conscripts.

BACKGROUND: Shock-absorbing and biomechanic shoe orthoses are frequently used in the prevention and treatment of back and lower extremity problems. One review concludes that the former is clinically effective in relation to prevention, whereas the latter has been tested in only 1 randomized clinical trial, concluding that stress fractures could be prevented. OBJECTIVES: To investigate if biomechanic shoe orthoses can prevent problems in the back and lower extremities and if reducing the number of days off-duty because of back or lower extremity problems is possible. DESIGN: Prospective, randomized, controlled intervention trial. STUDY SUBJECTS: One female and 145 male military conscripts (aged 18 to 24 years), representing 25% of all new conscripts in a Danish regiment. METHOD: Health data were collected by questionnaires at initiation of the study and 3 months later. Custom-made biomechanic shoe orthoses to be worn in military boots were provided to all in the study group during the 3-month intervention period. No intervention was provided for the control group. Differences between the 2 groups were tested with the chi-square test, and statistical significance was accepted at P <.05. Risk ratio (RR), risk difference (ARR), numbers needed to prevent (NNP), and cost per successfully prevented case were calculated. OUTCOME VARIABLES: Outcome variables included self-reported back and/or lower extremity problems; specific problems in the back or knees or shin splints, Achilles tendonitis, sprained ankle, or other problems in the lower extremity; number of subjects with at least 1 day off-duty because of back or lower extremity problems and total number of days off-duty within the first 3 months of military service because of back or lower extremity problems. RESULTS: Results were significantly better in an actual-use analysis in the intervention group for total number of subjects with back or lower extremity problems (RR 0.7, ARR 19%, NNP 5, cost 98 US dollars); number of subjects with shin splints (RR 0.2, ARR 19%, NNP 5, cost 101 US dollars); number of off-duty days because of back or lower extremity problems (RR 0.6, ARR < 1%, NNP 200, cost 3750 US dollars). In an intention-to-treat analysis, a significant difference was found for only number of subjects with shin splints (RR 0.3, ARR 18%, NNP 6 cost 105 US dollars), whereas a worst-case analysis revealed no significant differences between the study groups. CONCLUSIONS: This study shows that it may be possible to prevent certain musculoskeletal problems in the back or lower extremities among military conscripts by using custom-made biomechanic shoe orthoses. However, because care-seeking for lower extremity problems is rare, using this method of prevention in military conscripts would be too costly. We also noted that the choice of statistical approach determined the outcome.

Adolescent↗

Ethnic differences in forefoot shape and the determination of shoe comfort.

The kinanthropometric aspects of comfort of fit of sport shoes has not been subjected to any great scrutiny. It is suggested that comfort of fit is largely determined by the match of foot shape to shoe shape and consequently there is a need for normative data that describe foot shape, dimension and proportion for discrete populations. A study of 708 second generation Caucasian N. American (NA) and 513 Japanese and Korean (JK) male subjects was conducted to determine normative data with respect to forefoot shape and dimension. A series of 2 height, 7 length, 1 breadth and 1 girth measures of the right foot bearing full body weight was recorded using a modified Mitutoyo digital caliper interfaced with a micro-processor. Substantial differences were noted in the incidence of digital patterning. The relative proportion of digital patterns I (1 > 2 > 3 > 4 > 5) and II (2 > 1 > 3 > 4 > 5) were NA 76.09%, 23.91%; JK 50.80% and 49.20% respectively. The distance between the pternion and the distal extremity of the second digit expressed as a percentage of the maximum foot length (MFL) was found to be 98.60% (NA) and 99.60% (JK). In addition, the distance between the pternion and the distal extremity of the fifth digit relative to MFL was 82.60% (NA) and 85.00% (JK). The implication of these data is that the anterior margin of the JK foot makes a less acute angle with the long axis of the foot than the NA population. Additional information with respect to foot breadth leads to the conclusion that the shape of the JK forefoot differs from that of the NA, with the implication that unique shoe lasts for both populations are required for optimal shoe comfort.

Adult↗

Cytogenetic analysis of buccal cells from shoe-workers and pathology and anatomy laboratory workers exposed to n-hexane, toluene, methyl ethyl ketone and formaldehyde.

People employed in the shoe manufacture and repair industry are at an increased risk for cancer, the strongest evidence being for nasal cancer and leukaemia. A possible causal role for formaldehyde is likely for cancer of the buccal cavity and nasopharynx. Exfoliated buccal cells are good source of tissue for monitoring human exposure to inhaled and ingested occupational and environmental genotoxicants. To assess the cytogenetic damage related to occupational exposure to airborne chemicals during shoe-making and the processes in pathology and anatomy laboratories, the micronuclei (MN) count per 3000 cells was measured in buccal smears from shoe-workers (group I, n = 22) exposed to mainly n-hexane, toluene and methyl ethyl ketone (MEK) and from anatomy and pathology staff (group II, n = 28) exposed to formaldehyde (FA). Eighteen male university staff were used as controls. The mean time-weighted average (TWA) concentrations of n-hexane, toluene and MEK in 10 small shoe workshops were 58.07 p.p.m., 26.62 p.p.m. and 11.39 p.p.m., respectively. The measured air concentrations of FA in the breathing zone of the anatomy and pathology laboratory workers were between 2 and 4 p.p.m. Levels of 2,5-hexadione (2,5-HD) and hippuric acid (HA), metabolic markers of n-hexane and toluene exposure, respectively, were significantly higher in the urine of workers in group I than in control subjects (p < 0.001 and p < 0.01, respectively). The mean (+/- SD) MN (0/00) [corrected] frequencies in buccal mucosa cells from workers in group I, group II and controls were 0.62 +/- 0.45%, 0.71 +/- 0.56% and 0.33 +/- 0.30%, respectively (p < 0.05 and p < 0.05 compared with controls for group I and group II, respectively). The effects of smoking, age and duration of exposure on the frequency of micronucleated buccal cells from workers in all three groups studied were also evaluated. Overall, the results suggest that occupational exposure to organic solvents, mainly n-hexane, toluene, MEK and FA, may cause cytogenetic damage in buccal cells and that use of exfoliated buccal cells seems to be appropriate to measure exposure to organic solvents.

Anatomy↗

Shoes and insoles for patients with rheumatoid foot disease.

Pedorthic devices (shoes, modifications, insoles) are alternatives to, and, complementary with, operative procedures for patients with rheumatoid foot disease. The practical use of insoles and shoesole rolls (rocker soles) to diminish pressures and shearing stresses, and to support load bearing, is described. Criteria for prescribing such devices are described. The requirements for orthopaedic shoes are listed and a special technique of using test shoes with transparent thermomoldable stiff plastic materials is introduced to reveal pressure spots in advance of finishing the definitive shoe. Custom made pedorthic devices can improve loading capacity and mobility effectively even in severely deformed feet, thus being an important part of medical treatment.

Foot Deformities, Acquired↗

Gait function in spastic hemiparetic patients walking barefoot, with firm shoes, and with ankle-foot orthosis.

The purpose of the study was to investigate the effect of firm shoes and a particular type of a frequently prescribed ankle-foot orthosis in Germany, the Valens calliper, on functional gait parameters in hemiparetic patients with marked extensor spasticity and corresponding heel-strike problems. Cycle times, vertical ground reaction forces, trajectories of the centre of pressure (gait line) under the soles and the mode of initial contact were assessed in 19 hemiparetic patients walking barefoot, with firm shoes and the orthosis. With the shoes, significant improvements (p < 0.006) were observed for: walking velocity, stride length, initial double stance duration and gait line of the non-affected foot. The pattern of the vertical force diagram improved qualitatively in six patients. With the orthosis the following variables showed an even more marked improvement (p < 0.006): walking velocity, cadence, stride length, and gait line of both the affected and non-affected foot. Fourteen patients became rear-foot strikers and the vertical force pattern further improved in six patients. It is concluded that the ankle-foot orthosis (more than the shoes) provide a useful support in the early rehabilitation of hemiparetic patients with marked spasticity.

Adult↗

Altering muscle activity in the lower extremities by running with different shoes.

PURPOSE: To provide evidence that lower-extremity muscle activity during running is tuned in response to the loading rate of the impact forces at heel-strike. METHODS: Six runners ran two 30-min trials per week for 4 wk. The trials tested two shoes which differed only in the material hardness of the midsole. The shoes were tested in a randomized sequence. Bipolar surface EMG was recorded from the muscles of the rectus femoris, biceps femoris, medial gastrocnemius, and tibialis anterior. EMG was resolved into time-frequency space using wavelet techniques. EMG was analyzed for the 150 ms time window immediately before heel-strike. RESULTS: The intensity of the EMG and the ratio of the EMG intensity between high and low frequency components both showed significant changes between shoes, subjects, and muscles. Additionally, the intensity ratio showed a significant change over the course of each 30-min run. CONCLUSIONS: Lower-extremity muscle activity used to tune the muscles for the impact task can be altered by changing the material hardness of the shoe. The changes in the EMG frequency ratio suggest that muscle fiber-type recruitment patterns can also be altered by the choice of midsole material.

Adult↗

Outpatient treatment of unilateral diabetic foot ulcers with 'half shoes'.

The impact of 'half shoes' in the treatment of neuropathic forefoot ulcers was studied in two groups of diabetic patients, who were treated either by standard treatment alone (retrospective controls, n = 22), or by standard treatment plus 'half shoes' (cases, n = 26). The groups were matched for sex, age, type, and duration of diabetes and ulcer grading. The 'half-shoe' cases' vs controls' median overall healing time was 70 vs 118 days, the median difference being 48 (95% CI: -5 to 82) days (NS). In the case group, hospitalization was required in 1/26 (4%) of patients, vs 9/22 (41%) of the control patients (chi-square, p < 0.01). The home nursing service was required in 23% of the cases vs 18% of the controls (NS). It is concluded that the use of half-shoes, in conjunction with standard treatment provided by a specialized diabetic foot clinic, may reduce the overall healing time and does reduce the hospitalization rate. This has implications for a rational strategy of treating unilateral diabetic neuropathic foot ulcers.

Adult↗

New resin allergens in shoe contact dermatitis.

Changes in the shoe industry have replaced some of the former allergens and introduced some new ones. In 45 cases of shoe contact dermatitis, the lack of response to known allergens inspired the authors to review present-day industrial shoe manufacture. Two new resin allergens for shoe dermatitis have been found: dodecyl mercapthane and polyurethanes. The first is used in the plastics industry to arrest the polymerization process. We suggest the possibility that a certain number of Neoprene sensitizations could be sensitizations to dodecyl mercapthane contained in it. The recommended solution for patch testing is: 0.1% in toluol.

Allergens↗

Radiological assessment of the effects of a full rolling motion shoe during asymmetrical bearing.

The authors used a new radiological method to assess asymmetrical articular compression of the interphalangeal joints. This method was based on the measurements of 3 angles obtained on dorsopalmar radiographs. Variations of these angles were studied during experimental asymmetrical bearing on unshod feet. It was concluded that 2 angles were interesting parameters to assess asymmetrical articular compression and to define the position of the phalanx in the horny box. Furthermore, variations of these angles induced by experimental asymmetrical bearing were compared without shoe, with a standard shoe and with an orthopaedic full rolling motion shoe. It was observed that the effects of the asymmetrical bearing were reduced when feet were shod with a full rolling motion shoe.

Animals↗

The effect of shoeing on kinetics and kinematics during the stance phase.

The increasing range of of horseshoes and hoofpads makes it important to be able to evaluate their influence on performance and stress in the locomotor apparatus. The aim of this study was to describe the changes in ground reaction forces and locomotion pattern during the stance phase due to the application of a standard iron shoe. Six Swedish Warmblood horses were evaluated kinetically and kinematically before and after they were shod with an 8 mm iron shoe. Data were used to calculate ground reaction forces in the vertical and craniocaudal directions, point of application of the force, hoof segment angle and hoof joint, pastern joint, fetlock, carpal and tarsal angles. Finally joint angular velocity and landing velocity of the hoof were calculated. During the initial phase of the stance or the concussion phase, the horses altered the conditions of the limb, as reflected by hoof-landing velocities. Concussion-dampening mechanisms of the distal limb subsequently were altered. In the nonshod condition, the coffin and fetlock joints rotated more rapidly in the forelimb and less rapidly in the hindlimb, while earlier proximal off-loading by the carpus and tarsus resulted in a decrease in initial horizontal loading at the hoof. It was concluded that horses accustomed to standard iron shoes demonstrate slight but significant differences in the movement and loading of the distal limb due to shoeing. Though the main differences were related to the concussion phase of the stance, even mid-stance loading and roll-over were altered. The study provides a basis for further investigation of the effect of various farriery techniques on the hoof and movement of the horse.

Animals↗

Effects of various midsole densities of basketball shoes on impact attenuation during landing activities.

The purpose of this study was to examine effects of shoe midsole densities and mechanical demands (landing heights) on impact shock attenuation and lower extremity biomechanics during a landing activity. Nine healthy male college athletes performed 5 trials of step-off landing in each of 9 test conditions, i.e., a combination of landings in shoes of 3 midsole densities (soft, normal, hard) from each of 3 landing potential energy (PE) levels (low, median, high). Ground reaction forces (GRF), accelerations (ACC) of the tibia and forehead, and sagittal kinematic data were sampled simultaneously. A 3 x 3 two-way (surface x height) repeated-measures analysis of variance (ANOVA) was performed on selected kinematic, ACC, and GRF variables; a 3 x 3 x 3 three-way (surface x height x joint) ANOVA was performed on variables related to eccentric muscular work. The GRF results showed that the forefoot peak GRF in the normal and hard midsoles was significantly greater than the soft midsole at the low and median PEs. Rearfoot peak GRF was significantly greater for the hard midsole than for the soft and normal midsoles at the median and high PEs, respectively. The peak head and tibia peak ACC were also attenuated in similar fashion. Kinematic variables did not vary significantly across different midsoles, nor did energy absorbed through lower extremity extensors in response to the increased shoe stiffness. Knee joint extensors were shown to be dominant in attenuating the forefoot impact force across the landing heights. The results showed limited evidence of impact-attenuating benefits of the soft midsole in the basketball shoes.

Adult↗

Nasal cancer in the Northamptonshire boot and shoe industry.

A survey of the incidence of nasal cancer in Northamptonshire during the period 1953 to 1967 is reported. Of the 46 patients with nasal cancer ascertained during the 15-year period 21 (19 males and 2 females) had been employed at some time in the boot and shoe industry. Five other cases diagnosed either before 1953 or after 1967 in persons who had worked in the boot and shoe industry in Northamptonshire were ascertained from various sources.The incidence of nasal cancer (all histological types considered together) was significantly higher in male boot and shoe operatives in Northamptonshire than in males of all occupational classes in the Cancer Register areas selected for comparison and in males working in other occupations in Northamptonshire. The excess incidence has recently given rise to the occurrence of between 1 and 2 new cases per annum in the Northamptonshire boot and shoe industry.The cases within the Northamptonshire industry occurred almost entirely in the relatively small number of workers who are exposed to the dust of the materials used in the manufacture of footwear.Possibly there are two carcinogenic factors in the industry-one related to the production of nasal adenocarcinoma, and the other to squamous and possibly other types of carcinoma in the nasal cavity and sinuses. This requires further study. Our best estimate of the latent period for the adenocarcinoma cases was 54.6 years, which is substantially longer than for the patients with squamous, transitional, and anaplastic tumours (41.7 years). We have no evidence to answer the question whether the facts are still present in the industrial environment, though undoubtedly the standards of hygiene in the industry has improved substantially since these men were first exposed.There is probably an increased risk of nasal adenocarcinoma in the footwear repairing industry, but this requires further study. Our evidence suggests that snuff taking should be considered as a possible contributory factor in both industrial and non-industrial nasal cancer.A survey of the footwear manufacturing and repairing industry is recommended regarding cancer of the respiratory tract. Further attempts should be made to minimize the inhalation of dust. The case for the prescription of nasal cancer in the footwear industry should be considered.

Adenocarcinoma↗

Shoe-makers' polyneuropathy in Italy: the aetiological problem.

Since 1957, when the first cases of the so-called shoe-makers' toxic polyneuropathy were reported, nearly 400 cases have been described in the Italian literature. The substance that was considered to be responsible for the disease was triorthocresylphosphate (TOCP) contained in glues, artificial leathers, and some types of paints. However numerous chemical analyses of glues and leathers taken from factories where cases of the disease occurred have shown that in almost all instances little or no TOCP was present. In addition the disease manifests itself more frequently during winter and spring and this is not consistent with the absorption of the causative agent through the skin and/or gastrointestinal tract. In order to clarify the aetiology of the disease 122 workers in the shoe industry affected by toxic polymeuropathy during the period 1971-74 were studied. Workplaces where cases of polyneuropathy had occurred were visited and samples of glues and solvents were taken for chemical analysis. The polyneuropathy chiefly affects workers engaged in glueing and in the cleaning process, but it also affects those who do not have direct contact with glues or solvents. The disease is more common in women (68%) than in men (32%) and, in its more severe form begins with overwhelming prevalence during winter and early spring regardless of the job performed. No direct relationship has been found between the severity of the disease and the number of years of work in the shoe industry or of specific exposure (that is the number of years of work in the activity performed at the onset of the disease). The polyneuropathy is found almost exclusively among workers of the artisam type in small shoe factories, where standards of hygiene are low. Chemical analysis of glues and cleaning fluids collected from five different factories, where 20 cases of polyneuropathy occurred, showed the presence of paraffin hydrocarbons with a low boiling point (pentane, 2-methyl-pentane, 3-methyl-pentane, n-hexane, etc.) in concentrations of more than 80% by weight.

Adolescent↗