Preferred Offloading Modalities for Management of Diabetic Foot Ulcers in Private Clinical Settings: A Survey of Australian Podiatrists

Background Diabetic peripheral neuropathy is a common complication of diabetes mellitus. Neuropathy predisposes patients to diabetic foot ulcers (DFU) due to the loss of protective sensation and associated deformities. Management of foot ulcers are multifactorial, but pressure offloading can be considered as one of the most important aspects of management. According to IWGDF Guidelines, non-removable knee-high offloading devices are recommended as the 1st line of treatment for these ulcers. However, this is a very underutilised treatment modality. This study aimed to evaluate the practitioner preferred offloading modalities and reasons for their preference. Methods This project was approved by the university’s human research ethics committee. An online survey was distributed amongst Australian podiatrist via an industry related social media group. The survey collected simple demographical information, management strategies, preferred offloading modalities for the management of diabetic foot ulcers and reasons for their preferred method. Results Sixty-three podiatrists completed the survey with the majority practicing in private clinics. All practitioners treat diabetic foot ulcers regularly with most participants treating up to ten ulcer cases per week and 14% of participants treating more than 20 ulcers per week. Contrary to the IWGDF guidelines, standard therapeutic footwear was the most preferred method of management for the treatment of diabetic foot ulcers, with ease of use reported as the main reason for practitioners using this modality. Non-compliance to the use of non-removable knee-high offloading devices include perceived patient non-compliance and poor tolerance. Conclusion This study shows that practitioners’ offloading strategies do not adhere to the IWGDF guidelines. The reasons for not adhering to the guidelines seems to be a clinical practicality rather than evidence-based practice. Reasons for choosing a management strategy is multi-factorial (not just reducing plantar pressures). Further studies may be required to evaluate the effectiveness of therapeutic footwear in ulcer healing, taking into consideration other factors such as practitioner and patient preference, clinical practicality, and access to support. Based on the findings, this study provides suggestions on how to overcome the barriers that prevent podiatrist from adhering to the recommendations of the IWGDF when selecting offloading devices in general clinical practice.

Defining and grouping children’s therapeutic footwear and criteria for their prescription: an international expert Delphi consensus study

ObjectivesThis study aimed to achieve an expert consensus on how to define and group footwear interventions for children, with a further focus on the design characteristics and prescription of off-the-shelf stability footwear for children with mobility impairment.SettingA group of multinational professionals, from clinicians to those involved in the footwear industry, were recruited to ensure a spectrum of opinions.ParticipantsThirty panellists were contacted, of which 24 consented to participate and six withdrew before round 1, a further two withdrew after round 1. Sixteen panellists completed the consensus exercise.Primary and secondary outcome measuresA Delphi consensus method was employed with round 1 split into three sections: (1) terms and definitions, (2) specifics of off-the-shelf stability footwear design and (3) criteria for clinical prescription of off-the-shelf stability footwear. The panel was asked to rate their level of agreement with statements and to provide further insights through open-ended questions. The opinions of the experts were analysed to assess consensus set at 75% agreement or to modify or form new statements presented through the subsequent two rounds.ResultsTherapeutic footwear was the agreed term to represent children’s footwear interventions, with grouping and subgrouping of therapeutic footwear being dependent on their intended clinical outcomes (accommodative, corrective or functional). Both the heel counter and topline as well as the stiffness and width of the sole were identified as potentially influencing mediolateral stability in children’s gait. A consensus was achieved in the prescription criteria and outcome measures for off-the-shelf stability therapeutic footwear for cerebral palsy, mobile symptomatic pes planus, Duchenne muscular dystrophy, spina bifida and Down’s syndrome.ConclusionsThrough a structured synthesis of expert opinion, this study has established a standardisation of terminology and groupings along with prescription criteria for the first time. Reported findings have implications for communication between stakeholders, evidence-based clinical intervention and standardised outcome measures to assess effectiveness.

Effects of novel diabetic therapeutic footwear on preventing ulcer recurrence in patients with a history of diabetic foot ulceration: study protocol for an open-label, randomized, controlled trial

Background Recurrence after the healing of a foot ulcer is very common among patients with diabetes mellitus. Novel diabetic therapeutic footwear consisted of merino wool, vibration chip, and orthopedic insoles is designed to influence multifaceted mechanisms of foot ulcer occurrence. The aim of this study is to examine the effect of the optimally designed therapeutic footwear on preventing ulcer recurrence in patients with a history of diabetic foot ulcers (DFU). Methods/design The trial is designed as a two arms, parallel-group, open-label randomized controlled intervention study. The Log-rank Test was used for calculating sample size based on the latest national multicenter survey data of DFU in China. Three hundred and twenty participants will be recruited from the Diabetic Foot Care Center, West China Hospital, Sichuan University. Adults with diabetic peripheral neuropathy, healed foot ulceration in the 3 months prior to randomization, and aged ≥18 years, will be recruited. Participants will be randomized to receive novel diabetic therapeutic footwear (n = 160) or their own footwear (n = 160). The primary outcome will be the incidence of ulcer recurrence. The secondary outcome will be measurements of barefoot dynamic plantar pressures, the influence of footwear adherence on ulcer recurrence, and the incidence of cardiovascular events. Assessment visits and data collection will be obtained at baseline, 1, 3, 6, 9, and 12 months. The intention-to-treat principle will be applied. A cox regression model will be used to calculate the hazard ratio for the incidence of ulcer recurrence. The change of barefoot dynamic plantar pressures will be assessed using repeated measures ANOVA. The study protocol has been approved by the Ethics Committee of The Biomedical Research Ethics Committee of West China Hospital, Sichuan University (Reference No. 2019(96)). Discussion This clinical trial will give information on the ability of novel diabetic footwear on preventing ulcer recurrence in patients with a history of diabetic foot ulceration. If the optimally designed therapeutic footwear does work well, the findings will contribute to the development of innovative treatment devices for preventing foot ulcer recurrence in high-risk patients. Trial registration Chinese Clinical Trial Registry ChiCTR1900025538. Registered on 31 August 2019.

Material Analysis for Therapeutic Insoles

Background: Customized footwear with appropriate insole material for offloading is widely used for preventing ulceration indiabetic and leprosy affected patients.Methods: Finite element analysis was carried outon a 3 dimensionally modelledinsole. The insole was tested with the boundary condition of constant geometry, constant loading and varied material properties to identify the biomechanical behaviour of material.Results: The study demonstrates that Ethylene Vinyl Acetate and Micro Cellular Rubber reduce the elevated plantar pressure significantly in comparison to the other materials commonly used in fabricating foot orthosis.Conclusion: The comparison of the insole materials provides the health worker the required knowledge for selection of appropriate material for therapeutic insoles. The mechanical analysis of materials through the computer aided analysis would help therapeutic footwear designer to design, fabricate and use appropriate insoles.

Deformity and Clinical Outcomes Following Surgical Correction of Charcot Ankle

Category: Ankle, Ankle Arthritis, Diabetes, Hindfoot, Trauma Introduction/Purpose: Deformity associated with Charcot Foot Arthropathy leads to a poor quality of life in affected individuals. Deformity in the midfoot appears to be predictive of clinical outcomes following surgical correction. The goal of this retrospective study was to determine if that same methodology could be applied to patients treated for Charcot Foot Arthropathy involving the ankle joint. Methods: Fifty-six consecutive patients underwent surgical reconstruction of Charcot Foot deformity involving the ankle joint by a single surgeon over a fourteen year period. Preoperative patient characteristics and tibiotalar alignment, were recorded. Surgical treatment included single stage debridement of active infection and ankle arthrodesis with application of a circular external fixator when infection was present (39 of 56, 69.6%) or retrograde locked intramedullary nailing in the absence of infection (17 of 56, 30.3%). Clinical outcomes were graded based on limb salvage, resolution of infection and chronic wounds, and the ability to ambulate with therapeutic footwear or accommodative orthoses. The average follow-up was 7.5 (range 1.1-14.0) years. Results: One patient died at 134.3 weeks following surgery of unrelated causes and 8 underwent amputation. Twenty eight of 56 patients (50.0%) achieved a favorable (excellent or good) clinical outcome. There was no significant association between preoperative or postoperative alignment and clinical outcomes. Insulin-dependent diabetics were approximately 3 times more likely to have a poor clinical outcome. Conclusion: Surgical correction of Charcot deformity involving the ankle joint was associated with a high complication rate and risk for failure. The lessons learned from this highly co-morbid patient population with complex deformities can be used as a benchmark for applying modern surgical techniques.