An innovative sealed shoe to off-load and heal diabetic forefoot ulcers – a feasibility study

Jarl, Gustav; Tranberg, Roy

doi:10.1080/2000625x.2017.1348178

Cited by 18 publications

(15 citation statements)

References 14 publications

(15 reference statements)

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“…A validation set of 30 publications was created, including key studies known to the authors published since our previous search (July 29, 2014) . Using this set, the search strings used were validated; ie, each publication had to be identified before the search strings were used in this systematic review.…”

Section: Methodsmentioning

confidence: 99%

Effectiveness of offloading interventions to heal foot ulcers in persons with diabetes: a systematic review

Lazzarini

Jarl

Gooday

et al. 2020

Diabetes Metabolism Res

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246

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Background Offloading interventions are commonly used in clinical practice to heal foot ulcers. The aim of this updated systematic review is to investigate the effectiveness of offloading interventions to heal diabetic foot ulcers. Methods We updated our previous systematic review search of PubMed, EMBASE, and Cochrane databases to also include original studies published between July 29, 2014 and August 13, 2018 relating to four offloading intervention categories in populations with diabetic foot ulcers: (a) offloading devices, (b) footwear, (c) other offloading techniques, and (d) surgical offloading techniques. Outcomes included ulcer healing, plantar pressure, ambulatory activity, adherence, adverse events, patient‐reported measures, and cost‐effectiveness. Included controlled studies were assessed for methodological quality and had key data extracted into evidence and risk of bias tables. Included non‐controlled studies were summarised on a narrative basis. Results We identified 41 studies from our updated search for a total of 165 included studies. Six included studies were meta‐analyses, 26 randomised controlled trials (RCTs), 13 other controlled studies, and 120 non‐controlled studies. Five meta‐analyses and 12 RCTs provided high‐quality evidence for non‐removable knee‐high offloading devices being more effective than removable offloading devices and therapeutic footwear for healing plantar forefoot and midfoot ulcers. Total contact casts (TCCs) and non‐removable knee‐high walkers were shown to be equally effective. Moderate‐quality evidence exists for removable knee‐high and ankle‐high offloading devices being equally effective in healing, but knee‐high devices have a larger effect on reducing plantar pressure and ambulatory activity. Low‐quality evidence exists for the use of felted foam and surgical offloading to promote healing of plantar forefoot and midfoot ulcers. Very limited evidence exists for the efficacy of any offloading intervention for healing plantar heel ulcers, non‐plantar ulcers, and neuropathic ulcers with infection or ischemia. Conclusion Strong evidence supports the use of non‐removable knee‐high offloading devices (either TCC or non‐removable walker) as the first‐choice offloading intervention for healing plantar neuropathic forefoot and midfoot ulcers. Removable offloading devices, either knee‐high or ankle‐high, are preferred as second choice over other offloading interventions. The evidence bases to support any other offloading intervention is still weak and more high‐quality controlled studies are needed in these areas.

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Section: Methodsmentioning

confidence: 99%

Effectiveness of offloading interventions to heal foot ulcers in persons with diabetes: a systematic review

Lazzarini

Jarl

Gooday

et al. 2020

Diabetes Metabolism Res

Self Cite

246

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show abstract

“…This sensor is small, can be embedded in the insole of the shoe, is capable of long-term data collection (> 100 days), and is commercially available. This new sensor has been used in a study to assess adherence to wearing footwear (25). However, the validity and feasibility of this temperature sensor have not been investigated.…”

Section: Discussionmentioning

confidence: 99%

Validity and feasibility of a temperature sensor for measuring use and non-use of orthopaedic footwear

Lutjeboer¹,

Netten²,

Postema³

et al. 2018

J Rehabil Med

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LAY ABSTRACTOrthopaedic footwear is frequently prescribed to patients with a wide variety of pathologies, such as diabetes mellitus, rheumatoid arthritis, degenerative foot disorders and muscle disorders. For these patients, orthopaedic footwear is used for a range of serious foot and/or ankle problems; for example, to prevent the onset or recurrence of foot ulcers, to reduce pain, to support anatomical foot deformities, enhance stability and mobility, and redistribute plantar pressure. Orthopaedic footwear is only effective if they are used. To date, the use of orthopaedic footwear has mostly been assessed using questionnaires, interviews or diaries. However, these methods are not objective and lack accuracy. Temperature measurement can be used to determine the use of orthopaedic footwear. This study uses a new temperature sensor to objectively monitor use and non-use of orthopaedic footwear. Ten healthy participants were monitored over a period of 48 h using the sensor in their footwear. Footwear use based on the sensor data was compared with the reference standard, a camera attached to the footwear. The study found that the temperature sensor is a valid instrument to measure footwear use and non-use.Objective: Adherence is a prerequisite for the effectiveness of orthopaedic footwear. The aim of this study is to assess the validity of a new temperature sensor for objective assessment of footwear use and non-use. Design: Observational study. Methods: The validity of a temperature sensor (Orthotimer, Balingen, Germany) to discriminate between time periods of use and non-use of footwear over a period of 48 h was assessed using 3 algorithms, in 10 healthy participants (mean age 32.8 years (standard deviation (SD) 14.1 years)). Footwear use measured with the sensor was compared with a reference standard, footwear use measured with a time-lapse sports camera secured to the shoe. Main outcome measure: Hours of footwear use. Results: Mean footwear use measured with the camera was 8.10 (SD 2.46) h per day. Mean footwear uses measured with the sensor and calculated with the 3 algorithms were 8.16 (SD 2.37), 8.86 (SD 2.48) and 4.91 (SD 3.17) h per day for the Groningen algorithm, algorithm-25, and algorithm-29, respectively. The correlation between footwear use assessed with the camera and with the sensor was: r Groningen = 0.995, r alg25 = 0.919 and r alg29 = 0.680). Conclusion: The temperature sensor is a valid instrument to measure footwear use and non-use when using the Groningen algorithm.

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“…All the ulcers healed in a median of 56 days, and only one patient exhibited complications due to this therapy. More examination is needed to judge the effectiveness and safety of non-extractable devices to be used in the treatment of DFUs [129]. Another author examined the use of extracorporeal shock waves (ESWTs) for the treatment of DFUs.…”

Section: Devicesmentioning

confidence: 99%

Diabetic Foot Ulcers: Current Advances in Antimicrobial Therapies and Emerging Treatments

et al. 2019

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Diabetic foot ulcers (DFUs) are very important diabetes-related lesions that can lead to serious physical consequences like amputations of limbs and equally severe social, psychological, and economic outcomes. It is reported that up to 25% of patients with diabetes develop a DFU in their lifetime, and more than half of them become infected. Therefore, it is essential to manage infection and ulcer recovery to prevent negatives outcomes. The available information plays a significant role in keeping both physicians and patients aware of the emerging therapies against DFUs. The purpose of this review is to compile the currently available approaches in the managing and treatment of DFUs, including molecular and regenerative medicine, antimicrobial and energy-based therapies, and the use of plant extracts, antimicrobial peptides, growth factors, ozone, devices, and nano-medicine, to offer an overview of the assessment of this condition.2 of 32 history [2]. DFUs are one of the most severe complications of diabetes, and more than half of those ulcers become infected. Every single one of these infected lesions has the potential to get worse and compromise the integrity of the lower limbs. To avoid amputations and improve the patient's quality of life, it is very important to implement a strict program for the prevention and treatment of ulcers, as well as proper management of infections [3]. Thus, it is critical to keep diabetes patients aware of new therapies and treatments and their availability in the healthcare system. The treatment of DFUs requires a multidisciplinary approach with proper medical tools, skills, and knowledge. This starts from patient education, with the application of new classifications to guide the treatment to prevent amputations. New diagnosis methods should become available, such as the 16S ribosomal DNA sequence in bacteria, to provide a better understanding of the microbiota in DFUs. It is reported that DFU has a polymicrobial nature, and, according to its geographical location, certain marked differences, wound characteristics, antibiograms according to local epidemiology, individualized antimicrobial guided therapy, regular debridement, regular assessment of wounds, and change of dressings. The latter characteristics are also aided by new biological and molecular therapies that were proven to improve infection control, the regulation of the local inflammatory profile, and improved quality of the cicatrizing process. In the next sections, this review presents an approach for the diagnosis and treatment of DFUs, focusing on the current advances in antimicrobial therapies, such as dressings,

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An innovative sealed shoe to off-load and heal diabetic forefoot ulcers – a feasibility study

Cited by 18 publications

References 14 publications

Effectiveness of offloading interventions to heal foot ulcers in persons with diabetes: a systematic review

Effectiveness of offloading interventions to heal foot ulcers in persons with diabetes: a systematic review

Validity and feasibility of a temperature sensor for measuring use and non-use of orthopaedic footwear

Diabetic Foot Ulcers: Current Advances in Antimicrobial Therapies and Emerging Treatments

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