Off-loading Devices Research Articles

Diabetic Peripheral Neuropathy and Gait: Does Footwear Modify This Association?

Gait-related fall risk is the leading cause of mortality among patients with diabetes, especially those older than 65 years. Deterioration in balance and loss of protective sensation in lower extremities contribute significantly to fall risk in patients with diabetic peripheral neuropathy (DPN). This study aimed to explore the impact of neuropathy and foot ulcer on gait. We recruited 39 participants (age, 56.9 ± 8.2 years; body mass index, 29.6.3 ± 4.7 kg/m2), including 15 DPN patients without foot ulcers, 16 DPN patients with foot ulcers, and 8 healthy aged-matched controls. Patients with active foot ulcers wore an offloading device during gait examination, including removable cast walker. Results suggest that neuropathy alters gait mainly by increasing gait initiation, gait variability (coefficient of variation of gait velocity), and double support (DS) time, while reducing knee range of motion and center of mass sway (p < .05). Interestingly, the presence of foot ulcer does not impact gait velocity (p > .1) but enhances some of the gait parameters such as gait variability and DS time. This study demonstrates that neuropathy deteriorates gait, but the presence of foot ulcers does not alter gait parameters further than neuropathy. In addition, patients with foot ulcers demonstrated a better gait compared with DPN patients without ulcers. We speculate that offloading footwear may be enhancing the somatosensory feedback from sensate skin, thereby positively affecting gait parameters. A study with a larger sample is required to explore the effect of prescribed footwear in the DPN population in order to validate the findings of this research study.

Foot Care

Foot Care

Comparison of the clinical effectiveness of different off‐loading devices for the treatment of neuropathic foot ulcers in patients with diabetes: a systematic review and meta‐analysis

Effective off-loading is considered to be an important part of the successful clinical management of diabetic foot ulcers. The aim of this systematic review is to investigate the safety and effectiveness of different off-loading devices for the treatment of diabetic foot ulcers. The medical literature was extensively searched from January 1966 to May 2012. Systematic reviews and controlled studies that compared the use of different off-loading devices formed the evidence base. Studies were critically appraised to determine their risk of methodological bias, and data were extracted. Results were pooled using random effects meta-analysis and tested for heterogeneity. When compared with removable devices, non-removable off-loading devices were found, on average, to be more effective at promoting the healing of diabetic foot ulcers (RRp = 1.43; 95% CI 1.11, 1.84; I(2) = 66.9%; p = 0.001; k = 10). Analysis, stratified by type of removable device, did not detect a statistically significant difference between non-removable off-loading devices and removable cast walkers; however, on average non-removable off-loading devices performed better than therapeutic shoes at promoting the healing of diabetic foot ulcers (RRp = 1.68; 95% CI 1.09, 2.58; I(2) = 71.5%; p = 0.004; k = 6). The two types of non-removable off-loading devices i.e. total contact casts and instant total contact casts (removable cast walker rendered irremovable by securing with bandage or lace), were found to be equally effective (RRp = 1.06; 95% CI 0.88, 1.27; I(2) = 3.3%; p = 0.31; k = 2). In conclusion, non-removable off-loading devices regardless of type, are more likely to result in ulcer healing than removable off-loading devices, presumably because patient compliance with off-loading is facilitated.

Diabetic foot disease and oedema

Diabetic foot ulcers (DFUs) are common and disabling, giving rise to significant morbidity and mortality as well as worldwide socioeconomic problems. Despite treatment, DFUs readily become chronic wounds and may lead to major lower limb amputations. The pathogenesis of DFUs is complex and the main aetiologies are peripheral neuropathy, ischaemia from peripheral arterial disease and biomechanical abnormalities. Microvascular disease is also a significant problem for people with diabetes and contributes to foot ulceration. Successful management of DFUs consists of debridement, infection control, the use of offloading appliances and revascularisation where necessary. Foot ulcers are usually associated with infection and inflammation which lead to surrounding oedema of the foot. Standard offloading devices such as total contact casts and removable cast walkers do not actively reduce foot oedema. There is promising evidence that active oedema reduction by intermittent pneumatic compression in the diabetic foot improves ulcer healing. The objective of this article is to review the association of foot oedema and DFUs, including the role of appliances which reduce oedema. The information presented is vital to those involved in the management of DFUs.

A limb lost every 3 hours: can Australia reduce amputations in people with diabetes?

Recommendations to improve national diabetes-related foot disease (DRFD) care • National data collection on incidence and outcomes of DRFD. • Improved access to care, through the Medicare Benefits Schedule, for people with diabetes who have a current or past foot complication. • Standardised national model for interdisciplinary DRFD care. • National accreditation of interdisciplinary foot clinics and staff. • Subsidies for evidence-based treatments for DRFD, including medical-grade footwear and pressure off-loading devices. • Holistic diabetes care initiatives to “close the gap” on inequities in health outcomes for Aboriginal and Torres Strait Islander peoples.

Diabetic foot – what can we learn from leprosy? Legacy of Dr Paul W. Brand

Leprosy and diabetes, though two very different conditions, may both result in severe loss of sensation in the feet, which are then a great risk of painless injury and ulceration. Seminal observations made by the late Dr Paul W. Brand, a surgeon working with leprosy patients in South India in the mid-20th century, resulted in the subsequent development of treatments to manage insensitive foot ulcers that are today entirely applicable to patients with diabetes. As a consequence of his research, the recognition of the relationship between insensitivity, repetitive pressures and skin breakdown has helped our understanding of the aetiopathogenesis of neuropathic foot lesions in diabetes: the development of the total contact cast and other casting devices to treat such lesions forms the basis of management of diabetic foot lesions with off-loading devices that are widely used in the 21st century in diabetic foot clinics around the world. Moreover, observations by Brand that the foot 'heats up before it breaks down' resulted in more recent research showing that self-skin temperature monitoring might help reduce the incidence of recurrent neuropathic foot ulcers in diabetes. In summary, Brand's understanding of 'the gift of pain' that, when lost, results in the late complications of diabetic neuropathy has guided the prevention, diagnosis and management of diabetic foot problems in the 21st century.

Most Easy on the Pocket Offloading Device Costing &lt;1$ for Rural Diabetic Foot Ulcers

Objectives: The aim of our study is to compare mandakini offloading device suitable for low socio-economic rural population with conventional dressing in the treatment of diabetic foot plantar ulcers. Methods: From December 2010 to June 2012, 80 patients with diabetic plantar neuropathic ulcer were randomised to Mandakini offloading device (n=40) or Conventional dressing (n=40). Results: No significant differences between the two groups with respect to baseline ulcer size (4.52 vs 4.67 cms). The Number of patients with no necrotic tissue is significantly higher in Test group at 6th week follow up (32 vs 8). The number of patients with 75-100% wound filled by granulation tissue is significantly higher in test group at 6th week follow up (32 vs 8). The number of patients with no wound surface (Healed ulcer) is significantly higher in test group at 6th week follow up (32 vs 10). P value less than 0.001 was the level of significance. Conclusion: Mandakini offloading device is economical, effective and feasible for rural population.

Audit of acute Charcot’s disease in the UK: the CDUK study

We studied factors associated with the development and resolution of acute Charcot foot using a web-based observational study. Clinicians managing cases of acute Charcot foot in the UK and Ireland between June 2005 and February 2007 were invited to register anonymised details on a secure website. A total of 288 cases (age 57.0 ± 11.3 years [mean ± SD]; 71.2% male) were registered from 76 centres. Of these, 36% of patients recalled an episode of relevant trauma in the preceding 6 months, while 12% had had surgery to the affected foot. In 101 (35%) cases, ulceration was present at registration and 20% of these had osteomyelitis. Non-removable off-loading devices were used at presentation in 35.4% of cases, with removable off-loading used in 50%. Data on resolution were available for 219 patients. The median time to resolution was 9 months in patients whose initial management included the use of non-removable off-loading, compared with 12 months in the remainder (p = 0.001). Bisphosphonates were administered intravenously in 25.4% and orally in 19.4% of cases. The median time to resolution in patients who received bisphosphonates was 12 months and was longer than in those who did not (10 months, p = 0.005). The median time to resolution was longer than in earlier series. Although limited by being observational and non-randomised, these data suggest that the use of non-removable off-loading at presentation may shorten the time to resolution. They provide no evidence to indicate that the use of bisphosphonates is beneficial.

Human Fibroblast-Derived Dermal Substitute

To gain experience in the use of Dermagraft (Advanced Biohealing Inc, La Jolla, California), a human fibroblast-derived dermal substitute (HFDS), for the treatment of nonhealing diabetic foot ulcers (DFUs). An open label, noncontrolled, multicenter clinical trial of HFDS in the treatment of DFU was conducted. Subjects with DFUs underwent sharp debridement of the study ulcer and were prescribed an off-loading device. All of the subjects enrolled received applications of HFDS, beginning at day 0 and applied weekly thereafter, along with saline gauze or polyurethane foam dressings from day 0 to week 20. A maximum of 8 HFDS applications was allowed. The primary and secondary end points of the study were complete wound closure by weeks 12 and 20, respectively. A total of 23 centers screened 91 subjects, and 18 centers enrolled an intent-to-treat (ITT) population of 62 subjects. For the ITT population, 27 (44%) subjects healed by week 12, and 32 (52%) healed by week 20. Fifty-one subjects (82%) completed the study to week 12, and 46 subjects (74%) completed the entire 20-week study; wound closure rates in these groups were 59% and 70%, respectively. Median time to healing was 13 weeks. The overall incidence of at least 1 adverse event (44%, 27/62) was typical for this subject population. No adverse events were attributable to HFDS. Data from this study support the safety and efficacy of HFDS in the treatment of nonhealing DFUs.

Removable cast walker boots yield greater forefoot off-loading than total contact casts

Background Elevated plantar loading has been implicated in the etiology of plantar ulceration in individuals with diabetes mellitus and peripheral neuropathy. Total contact casts and cast walker boots are common off-loading strategies to facilitate ulcer healing and prevent re-ulceration. The purpose of this study was to compare off-loading capabilities of these strategies with respect to plantar loading during barefoot walking. Methods Twenty-three individuals with diabetes, peripheral neuropathy, and plantar ulceration were randomly assigned to total contact cast (n = 11) or removable cast walker boot (n = 12). Each subject underwent plantar loading assessment walking barefoot and wearing the off-loading device. Analysis of covariance was used to compare loading patterns in the off-loading devices for the whole foot, hindfoot, midfoot, and forefoot while accounting for walking speed and barefoot loading. Findings For the foot as a whole, there were no differences in off-loading between the two techniques. Subjects wearing cast walker boots had greater reductions in forefoot peak pressure, pressure-time integral, maximum force, and force-time integral with respect to barefoot walking. Healing times were similar between groups, but a greater proportion of ulcers healed in total contact casting compared to cast walker boots. Interpretation In subjects with diabetes, peripheral neuropathy, and plantar ulceration, cast walker boots provided greater load reduction in the forefoot, the most frequent site of diabetic ulceration, though a greater proportion of subjects wearing total contact casts experienced ulcer healing. Taken together, the less effective ulcer healing in cast walker boots despite superior forefoot off-loading suggests an important role for patient compliance in ulcer healing.

Off-Loading Practices for the Wounded Foot: Concepts and Choices

A wound practitioner's best-laid plan of care and strategy for healing an ulcerated foot is doomed to fail without a properly conceived approach based on sound off-loading principles. Wound healing that has stalled despite best-practice techniques may require reevaluation of off-loading choices. This is particularly true in the patient with abnormal foot pathologies. Special considerations are certainly required with neuropathic ulcers; however, any wound on a weight-bearing surface of the foot requires proper off-loading. This discussion explores the basic biomechanical and pathomechanical concepts that modify and influence ambulation and gait patterns. Integration of these concepts into the choices for off-loading to deter pathologic influences will alert the reader of precautionary measures and other factors for consideration. The aim of this column is to provide both an adequate working knowledge of the available off-loading devices and the necessary tools and concepts needed to stimulate wise decision protocols for wound management and healing.

Effectiveness of Removable Walker Cast Versus Nonremovable Fiberglass Off-Bearing Cast in the Healing of Diabetic Plantar Foot Ulcer

OBJECTIVETo evaluate the efficacy of a removable cast walker compared with that of a nonremovable fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer.RESEARCH DESIGN AND METHODSForty-five adult diabetic patients with nonischemic, noninfected neuropathic plantar ulcer were randomly assigned for treatment with a nonremovable fiberglass off-bearing cast (total contact cast [TCC] group) or walker cast (Stabil-D group). Treatment duration was 90 days. Percent reduction in ulcer surface area and total healing rates were evaluated after treatment.RESULTSA total of 48 patients were screened; however, 2 patients in the TCC group and 1 patient in the Stabil-D group did not complete the study and were considered dropouts. There were no significant differences in demographic and clinic characteristics of the 45 patients completing the study. Ulcer surface decreased from 1.41 to 0.21 cm2 (P < 0.001) in the TCC group and from 2.18 to 0.45 cm2 (P < 0.001) in the Stabil-D group, with no significant differences between groups (P = 0.722). Seventeen patients (73.9%) in the TCC group and 16 patients (72.7%) in the Stabil-D group achieved healing (P = 0.794). Average healing time was 35.3 ± 3.1 and 39.7 ± 4.2 days in the TCC and Stabil-D group, respectively (P = 0.708).CONCLUSIONSThe Stabil-D cast walker, although removable, was equivalent in efficacy to the TCC in terms of ulcer size reduction and total healing rate. The easier use of Stabil-D may help increase the use of off-loading devices in the management of plantar neuropathic diabetic foot ulcers.

Transitional Off-loading

To enhance the learner's competence in providing pressure redistribution therapy for the diabetic foot. This continuing education activity is intended for physicians and nurses with an interest in skin and wound care. After participating in this educational activity, the participant should be better able to: 1. Relate diabetic foot problems to the need for using off-loading devices. 2. Distinguish between the various types of dressings and off-loading devices used for diabetic foot wounds. 3. Apply the "transitional approach" to off-loading the diabetic foot.

The economical way to off-load diabetic foot ulcers [Mandakini off-loading device

We all know that increased plantar foot pressure is a leading cause of ulceration in the diabetic population. Healing of these ulcers requires adequate blood supply, control of infection, excellent wound care and 'offloading' or pressure redistribution of the ulcerative area [1, 2]. Out of all these factors, 'offloading' is a unique challenge in treating chronic wounds. As diabetic foot care has evolved over the years, podiatrists have used numerous approaches including complete bed rest, cutout felt pads, crutches, wheelchairs, zimmer frame, temporary shoes, ortho wedge shoes like rocker-bottom wedge design shoes and total contact casting to offload these wounds [3, 4, 5].

Controversies in off-loading: Should big brother be watching?

Introduction Compliance with off-loading devices is crucial to healing diabetic foot ulcers. Should we be dependent on patient self-report to determine compliance? Advancements in technology over the past few decades have led to nearly instantaneous accessibility to unlimited amounts of information. However, as care providers we are often still in the dark as to what patients actually do once they leave our offi ce. The application of current technologies to patient monitoring could change this.

A proof‐of‐concept study of the effectiveness of a removable device for offloading in patients with neuropathic ulceration of the foot: the Ransart boot

To undertake a proof-of-concept study to determine whether a removable offloading device (the Ransart boot) for the management of diabetic foot ulcers (DFU) was as effective as reports of non-removable devices. This observational study used the Ransart boot for patients with DFU, in seven specialist centres. If a patient had two or more ulcers, one was selected as the index ulcer. Ulcers were classified by the University of Texas (UT) system. There were 135 patients (mean age 60.3 +/- 11.4 years); 96 (71.1%) male. Median ulcer duration at presentation was 90 [interquartile range (IQR) 30-1825] days. Seven were lost to follow-up, seven developed other major illnesses and four died; outcomes were documented in the remaining 117. Eighty-two (70.1% of 117) healed, after a median (IQR) 60 (43-99) days, while 22 (18.8%) ulcers were resolved by amputation (one major). The remaining 13 (11.1%) patients were judged non-compliant. There was a close correlation between ulcer classification at baseline and both time to healing (P < 0.001 chi(2)-test) and amputation (P < 0.001; Spearman's rank correlation coefficient). There was a positive correlation between ulcer duration at presentation and time to healing (P < 0.02), UT class (P < 0.01), glycated haemoglobin (P < 0.02) and amputation (P < 0.04). Time to healing and incidence of amputation were comparable with those previously reported for non-removable devices. Given that a removable device is much more acceptable to the patient, the effectiveness, cost and acceptability of the removable devices, such as the Ransart boot, need to be compared with a non-removable device in a randomized trial. Diabet. Med. 26, 778-782 (2009).

A Method for Assessing Off-loading Compliance

Off-loading excessive pressure is essential to healing diabetic foot ulcers. However, many patients are not compliant in using prescribed footwear or off-loading devices. We sought to validate a method of objectively measuring off-loading compliance via activity monitors. For 4 days, a single subject maintained a written compliance diary concerning use of a removable cast walker. He also wore a hip-mounted activity monitor during all waking hours. An additional activity monitor remained mounted on the cast walker at all times. At the conclusion of the 4 days, the time-stamped hip activity data were independently coded for walker compliance by the compliance diary and by using the time-stamped walker activity data. An intraclass reliability of 0.93 was found between diary-coded and walker monitor-coded activity. These results support the use of this dual activity monitor approach for assessing off-loading compliance. An advantage of this approach versus a patient-maintained diary is that the monitors are not susceptible to incorrect patient recall or a patient's desire to please a caregiver by reporting inflated compliance. Furthermore, these results seem to lend support to existing reports in the literature using similar methods.

The Use of a Kickstand Modification for the Prevention of Heel Decubitus Ulcers in Trauma Patients With Lower Extremity External Fixation

External fixation is frequently used to manage patients with lower extremity trauma. Excessive pressure from contact surfaces must be avoided to prevent added morbidity from heel ulcers. The purpose of this article is to present a simple solution to off-load the heel by adding a "kickstand" to the external fixator. The kickstand modification is designed to prevent breakdown of the soft tissue covering of the heel that can complicate the treatment of the initial injury and may also result in calcaneal osteomyelitis. By preventing such damage, the kickstand modification may also help to avoid radical procedures for soft tissue coverage, prolonged treatment times, and, ultimately, amputations. The kickstand device is made by adapting 2 extra rods and clamps to the primary external fixator to obtain proper clearance of the heel when the foot is resting over a surface. In cases where traditional off-loading devices are difficult to apply and can interfere with proper wound care, the kickstand might provide a useful preventive solution. From January to August 2006, we applied this technique in 10 patients with lower extremity trauma (11 fractures) and have seen no heel ulcers or other complications as per the staging system from the National Pressure Ulcer Advisory Panel.

Use of Pressure Offloading Devices in Diabetic Foot Ulcers

OBJECTIVE—Pressure mitigation is crucial for the healing of plantar diabetic foot ulcers. We therefore discuss characteristics and considerations associated with the use of offloading devices.RESEARCH DESIGN AND METHODS—A diabetic foot ulcer management survey was sent to foot clinics in all 50 states and the District of Columbia in 2005. A total of 901 geographically diverse centers responded. The survey recorded information regarding usage frequency and characteristics of assessment and treatment of diabetic foot ulcers in each center.RESULTS—Of the 895 respondents who treat diabetic foot ulcers, shoe modifications (41.2%, P < 0.03) were the most common form of pressure mitigation, whereas total contact casts were used by only 1.7% of the centers.CONCLUSIONS—This study reports the usage and characteristics of offloading devices in the care of diabetic foot ulcers in a broadly distributed geographic sample. Less than 2% of specialists use what has been termed the “gold standard” (total contact cast) for treating the majority of diabetic foot ulcers.

Off-Loading of Hindfoot and Midfoot Neuropathic Ulcers Using a Fiberglass Cast with a Metal Stirrup

This study was designed to assess the effectiveness of a method of off-loading large neuropathic ulcers of the hindfoot and midfoot. The device used is composed of a fiberglass cast with a metal stirrup and a window around the ulcer. A retrospective study of 14 diabetic and nondiabetic patients was performed. All had chronic plantar hindfoot or midfoot neuropathic ulcers that failed to heal with conventional treatment methods. A fiberglass total contact cast with a metal stirrup was applied. A window was made over the ulcer to allow daily ulcer care. The average duration of ulcer before application of the metal stirrup was 26 + 13.2 (range 7 to 52) months. The ulcer completely healed in 12 of the 14 patients treated. The mean time for healing was 10.8 weeks for midfoot ulcers and 12.3 weeks for heel ulcers. Complications developed in four patients: three developed superficial wounds and one developed a full-thickness wound. In three of these four patients, local wound care was initiated, and the stirrup cast was continued to complete healing of the primary ulcer. A fiberglass cast with a metal stirrup is an effective off-loading device for midfoot and hindfoot ulcers. It is not removable and does not depend on patient compliance. The window around the ulcer allows for daily wound care, drainage of the ulcer and the use of vacuum-assisted closure (VAC) treatment. The complication rate is comparable to that of total contact casting.