A survey of offloading practices for diabetes-related plantar neuropathic foot ulcers.
ABSTRACT: BACKGROUND: Offloading is key to preventing or healing plantar neuropathic foot ulcers in diabetes. Total contact casts or walkers rendered irremovable are recommended in guidelines as first-line options for offloading, however the use of such devices has been found to be low. This study aimed to investigate offloading practices for diabetes-related plantar neuropathic ulcers. METHODS: An online survey of closed and open-ended questions was administered via SurveyMonkey®. Forty-one podiatrists experienced in high-risk foot practice, from 21 high-risk foot services around Australia, were approached to participate. RESULTS: The response rate was 88%. Participants reported using 21 modalities or combinations of modalities, for offloading this ulcer type. The most frequently used modalities under the forefoot and hallux were felt padding, followed by removable casts or walkers, then non-removable casts or walkers. Participants indicated that many factors were considered when selecting offloading modality, including: compliance, risk of adverse effects, psycho-social factors, restrictions on activities of daily living, work needs and features of the wound. The majority of participants (83%) considered non-removable casts or walkers to be the gold-standard for offloading this ulcer type, however they reported numerous, particularly patient-related, barriers to their use. CONCLUSIONS: Selecting offloading for the management of foot ulceration is complex. Felt padding, not the gold-standard non-removable cast or walker, was reported as the most commonly selected modality for offloading plantar neuropathic ulceration. However, further evaluation of felt padding in high quality clinical trials is required to ascertain its effectiveness for ulcer healing.
Project description:INTRODUCTION:The offloading is crucial to heal neuropathic diabetic foot ulcer (DFU). Removable offloading are the most used devices. Orthèse diabète is a new customized removable knee-high offloading device immobilizing foot and ankle joints, with some specific and innovative features that may improve offloading. We aimed to evaluate the efficiency of this device in DFU healing. RESEARCH, DESIGN AND METHODS:The evaluation of Offloading using a new removable ORTHOsis in DIABetic foot study is a French multicenter (13 centers) randomized controlled trial with blinded end points evaluation. Adults with neuropathic DFU were randomly assigned to either Orthèse Diabète (experimental device), or any type of conventional (usually used in France) removable offloading devices (control group). The primary outcome was the 3-month proportion of patients with fully healed DFU. RESULTS:Among 112 randomized patients (men 78%, age 62±10 years), the primary outcome occurred in 19 (33%) participants using conventional device vs 19 (35%) Orthèse Diabète users (p=0.79). Study groups were also comparable in terms of prespecified secondary end points including occurrence of new DFU (25% vs 27% in conventional and experimental groups), ipsilateral lower-limb amputation (4% vs 10%) or infectious complications (14% vs 13%) (p>0.05 for all). Adverse events were comparable between groups, including 4 deaths unrelated to study allocation (1 sudden death, 2 ventricular arrhythmias and 1 pancreatic cancer). Adverse events believed to be related to the device were higher in the Orthèse Diabète group than in the control group (15% vs 4%). Orthèse Diabète was less frequently worn than conventional devices (46% vs 66%, p=0.04). CONCLUSIONS:Orthèse Diabète, a new removable offloading orthosis immobilizing foot and ankle joints did not show superiority compared with conventional removable devices in neuropathic DFU healing and cannot be recommended to heal DFU. TRIAL REGISTRATION NUMBER:NCT01956162.
Project description:OBJECTIVE:To 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 METHODS:Forty-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. RESULTS:A 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 cm(2) (P < 0.001) in the TCC group and from 2.18 to 0.45 cm(2) (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). CONCLUSIONS:The 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.
Project description:Repetitive stress on the neuropathic plantar foot is the primary cause of diabetic foot ulcers. After healing, recurrence is common. Modulating plantar pressure has been associated with extension of ulcer free days. Therefore, the goal of this study was to determine the effects of an injectable allograft adipose matrix in providing a protective padding and reducing the pressure in the plantar foot.After healing his recurrent ulcer using total contact casting, a 71-year-old man with a 9-year history of recurrent diabetic foot ulcers was treated with injection of allograft adipose matrix, procured from donated human tissue. This was delivered under postulcerative callus on the weight-bearing surface of the distal end of the first ray resection. As is standard in our clinic for tissue augmentation procedures, our patient underwent serial plantar pressure mapping using an in-shoe pressure monitoring system.There was a 76.8% decrease in the mean peak pressure due to the fat matrix injected into the second metatarsal region and a 70.1% decrease in mean peak pressure for the first ray resection at the site of the postulcerative callus. By 2 months postoperatively, there was no evidence of residual callus. This extended out to the end of clinical follow-up at 4 months.The results from this preliminary experience suggest that allograft adipose matrix delivered to the high risk diabetic foot may have promise in reducing tissue stress over pre- and postulcerative lesions. This may ultimately assist the clinician in extending ulcer-free days for patients in diabetic foot remission.
Project description:Diabetic foot ulcers are frequently related to elevated pressure under a bony prominence. Conservative treatment includes offloading with orthopaedic shoes and custom made orthotics or plaster casts. While casting in plaster is usually effective in achieving primary closure of foot ulcers, recurrence rates are high. Minimally invasive surgical offloading that includes correction of foot deformities has good short and long term results. The surgery alleviates the pressure under the bony prominence, thus enabling prompt ulcer healing, negating the patient's dependence on expensive shoes and orthotics, with a lower chance of recurrence. The purpose of this protocol is to compare offloading surgery (percutaneous flexor tenotomy, mini-invasive floating metatarsal osteotomy or Keller arthroplasty) to non-surgical treatment for patients with diabetic foot ulcers in a semi-crossover designed RCT.One hundred patients with diabetic neuropathy related foot ulcers (tip of toe ulcers, ulcers under metatarsal heads and ulcers under the hallux interphalangeal joint) will be randomized (2:3) to a surgical offloading procedure or best available non-surgical treatment. Group 1 (surgery) will have surgery within 1 week. Group 2 (controls) will be prescribed an offloading cast applied for up to 12 weeks (based on clinical considerations). Following successful offloading treatment (ulcer closure with complete epithelization) patients will be prescribed orthopaedic shoes and custom made orthotics. If offloading by cast for at least 6 weeks fails, or the ulcer recurs, patients will be offered surgical offloading. Follow-up will take place till 2 years following randomization. Outcome criteria will be time to healing of the primary ulcer (complete epithelization), time to healing of surgical wound, recurrence of ulcer, time to recurrence and complications.The high recurrence rate of foot ulcers and their dire consequences justify attempts to find better solutions than the non-surgical options available at present. To promote surgery, RCT level evidence of efficacy is necessary.Israel MOH_2017-08-10_000719. NIH: NCT03414216.
Project description:BACKGROUND:In people with diabetes, offloading high-risk foot regions by optimising footwear, or insoles, may prevent ulceration. This systematic review aimed to summarise and evaluate the evidence for footwear and insole features that reduce pathological plantar pressures and the occurrence of diabetic neuropathy ulceration at the plantar forefoot in people with diabetic neuropathy. METHODS:Six electronic databases (Medline, Cinahl, Amed, Proquest, Scopus, Academic Search Premier) were searched in July 2019. The search period was from 1987 to July 2019. Articles, in English, using footwear or insoles as interventions in patients with diabetic neuropathy were reviewed. Any study design was eligible for inclusion except systematic literature reviews and case reports. Search terms were diabetic foot, physiopathology, foot deformities, neuropath*, footwear, orthoses, shoe, footwear prescription, insole, sock*, ulcer prevention, offloading, foot ulcer, plantar pressure. RESULTS:Twenty-five studies were reviewed. The included articles used repeated measure (n?=?12), case-control (n?=?3), prospective cohort (n?=?2), randomised crossover (n?=?1), and randomised controlled trial (RCT) (n?=?7) designs. This involved a total of 2063 participants. Eleven studies investigated footwear, and 14 studies investigated insoles as an intervention. Six studies investigated ulcer recurrence; no study investigated the first occurrence of ulceration. The most commonly examined outcome measures were peak plantar pressure, pressure-time integral and total contact area. Methodological quality varied. Strong evidence existed for rocker soles to reduce peak plantar pressure. Moderate evidence existed for custom insoles to offload forefoot plantar pressure. There was weak evidence that insole contact area influenced plantar pressure. CONCLUSION:Rocker soles, custom-made insoles with metatarsal additions and a high degree of contact between the insole and foot reduce plantar pressures in a manner that may reduce ulcer occurrence. Most studies rely on reduction in plantar pressure measures as an outcome, rather than the occurrence of ulceration. There is limited evidence to inform footwear and insole interventions and prescription in this population. Further high-quality studies in this field are required.
Project description:AIMS:To assess the effect of data-driven custom-made footwear concepts on plantar pressure relief to prevent diabetic foot ulceration. METHODS:Twenty-four neuropathic diabetic patients at high risk of foot ulceration were measured for in-shoe plantar pressures during walking in four data-driven custom-made footwear conditions, an athletic shoe and an off-the-shelf non-therapeutic shoe. Two evidence-based footwear conditions (Shoe-A; Insole-A) follow a scientific-based design protocol, are handmade, and use in-shoe plantar pressure guided optimization. One evidence-based insole condition (Insole-B) uses a barefoot plantar pressure and 3D foot shape-based computer-assisted design and manufacturing (CADCAM) routine. And one insole condition (Insole-C) uses a barefoot and in-shoe plantar pressure and 3D foot shape-based CADCAM design and optimization routine. Patient satisfaction was scored on walking comfort, shoe fit, weight and appearance. RESULTS:All data-driven footwear conditions significantly reduced metatarsal head peak pressure compared with the non-therapeutic shoe (17-53% relief). Shoe-A and Insole-A showed the lowest metatarsal head peak pressures (mean 112-155 kPa, 90-98% of cases <200 kPa), significantly lower than for Insole-B and Insole-C (mean 119-199 kPa, 52-100% <200 kPa). Patient satisfaction was not significantly different between footwear concepts. CONCLUSIONS:This study proves the offloading efficacy of a scientific-based, handmade, and in-shoe plantar pressure data-driven approach to custom-made footwear design, and advocates its implementation to optimize diabetic footwear for plantar foot ulcer prevention.
Project description:Off-loading is essential for diabetic foot management, but remains understudied. The evaluation of Off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) trial aims to evaluate the efficacy of a new removable device "Orthèse Diabète" in the healing of diabetic foot.ORTHODIAB is a French multi-centre randomized, open label trial, with a blinded end points evaluation by an adjudication committee according to the Prospective Randomized Open Blinded End-point. Main endpoints are adjudicated based on the analysis of diabetic foot photographs. Orthèse Diabète is a new removable off-loading orthosis (PROTEOR, France) allowing innovative functions including real-time evaluation of off-loading and estimation of patients' adherence. Diabetic patients with neuropathic plantar ulcer or amputation wounds (toes or transmetatarsal) are assigned to one of 2 parallel-groups: Orthèse Diabète or control group (any removable device) according to a central computer-based randomization. Study visits are scheduled for 6 months (days D7 and D14, and months M1, M2, M3, and M6). The primary endpoint is the proportion of patients whose principal ulcer is healed at M3. Secondary endpoints are: the proportion of patients whose principal ulcer is healed at M1, M2 and M6; the proportion of patients whose initial ulcers are all healed at M1, M2, M3, and M6; principal ulcer area reduction; time-related ulcer-free survival; development of new ulcers; new lower-extremity amputation; infectious complications; off-loading adherence; and patient satisfaction. The study protocol was approved by the French National Agency for Medicines and Health Products Safety, and by the ethics committee of Saint-Louis Hospital (Paris). Comprehensive study information including a Patient Information Sheet has been provided to each patient who must give written informed consent before enrolment. Monitoring, data management, and statistical analyses are providing by UMANIS Life Science (Paris), independently to the sponsor. Since 27/10/2013, 13 centres have agreed to participate in this study, 117 participants were included, and 70 have achieved the study schedules. The study completion is expected for the end of 2016, and the main results will be published in 2017.ORTHODIAB trial evaluates an innovating removable off-loading device, seeking to improve diabetic foot healing (ClinicalTrials.gov identifier: NCT01956162).
Project description:<h4>Background</h4>Elevated plantar pressures represent a significant risk factor for neuropathic diabetic foot (NDF) ulceration. Foot offloading, through custom-made insoles, is essential for prevention and healing of NDF ulcerations. Objective quantitative evaluation to design custom-made insoles is not a standard method. Aims: 1) to develop a novel quantitative-statistical framework (QSF) for the evaluation and design of the insoles' offloading performance through in-shoe pressure measurement; 2) to compare the pressure-relieving efficiency of traditional shape-based total contact customised insoles (TCCI) with a novel CAD-CAM approach by the QSF.<h4>Methods</h4>We recruited 30 neuropathic diabetic patients in cross-sectional study design. The risk-regions of interest (R-ROIs) and their areas with in-shoe peak pressure statistically ?200kPa were identified for each patients' foot as determined on the average of peak pressure maps ascertained per each stance phase. Repeated measures Friedman test compared R-ROIs' areas in three different walking condition: flat insole (FI); TCCI and CAD-CAM insoles.<h4>Results</h4>As compared with FI (20.6±12.9 cm2), both the TCCI (7±8.7 cm2) and the CAD-CAM (5.5±7.3 cm2) approaches provided a reduction of R-ROIs mean areas (p<0.0001). The CAD-CAM approach performed better than the TCCI with a mean pressure reduction of 37.3 kPa (15.6%) vs FI.<h4>Conclusions</h4>The CAD-CAM strategy achieves better offloading performance than the traditional shape-only based approach. The introduced QSF provides a more rigorous method to the direct 200kPa cut-off approach outlined in the literature. It provides a statistically sound methodology to evaluate the offloading insoles design and subsequent monitoring steps. QSF allows the analysis of the whole foot's plantar surface, independently from a predetermined anatomical identification/masking. QSF can provide a detailed description about how and where custom-made insole redistributes the underfoot pressure respect to the FI. Thus, its usefulness extends to the design step, helping to guide the modifications necessary to achieve optimal offloading insole performances.
Project description:High plantar pressures are implicated in the development of diabetes-related foot ulcers. Whether plantar pressures remain high in patients with chronic diabetes-related foot ulcers over time is uncertain. The primary aim of this study was to compare plantar pressures at baseline and three and six months later in participants with chronic diabetes-related foot ulcers (cases) to participants without foot ulcers (controls).Standardised protocols were used to measure mean peak plantar pressure and pressure-time integral at 10 plantar foot sites (the hallux, toes, metatarsals 1 to 5, mid-foot, medial heel and lateral heel) during barefoot walking. Measurements were performed at three study visits: baseline, three and six months. Linear mixed effects random-intercept models were utilised to assess whether plantar pressures differed between cases and controls after adjusting for age, sex, body mass index, neuropathy status and follow-up time. Standardised mean differences (Cohen's d) were used to measure effect size.Twenty-one cases and 69 controls started the study and 16 cases and 63 controls completed the study. Cases had a higher mean peak plantar pressure at several foot sites including the toes (p = 0.005, Cohen's d = 0.36) and mid-foot (p = 0.01, d = 0.36) and a higher pressure-time integral at the hallux (p<0.001, d = 0.42), metatarsal 1 (p = 0.02, d = 0.33) and mid-foot (p = 0.04, d = 0.64) compared to controls throughout follow-up. A reduction in pressure-time integral at multiple plantar sites over time was detected in all participants (p<0.05, respectively).Plantar pressures assessed during gait are higher in diabetes patients with chronic foot ulcers than controls at several plantar sites throughout prolonged follow-up. Long term offloading is needed in diabetes patients with diabetes-related foot ulcers to facilitate ulcer healing.
Project description:Background: Non-removable knee-high devices are the gold standard to treat diabetic foot ulcers located on the plantar forefoot, but they immobilize the ankle, which restricts daily life activities and has negative effects on joint functioning. Objective: To investigate the feasibility of sealing a therapeutic shoe to off-load and heal diabetic forefoot ulcers. Design: A case series of seven men with type 2 diabetes and a metatarsal head ulcer were prescribed therapeutic shoes and custom-made insoles. The shoe was sealed with a plastic band. Off-loading was assessed with the F-scan pressure measurement system. Adherence to wearing the shoe was assessed with a temperature sensor and by documenting the status of the seal. Results: The off-loading was effective and all ulcers healed. Median time to healing was 56 days (range 8-160). Complications were secondary ulcer (n = 1) and plantar hematoma (n = 1). Five of seven participants did not disturb the seal. Conclusions: Sealing a therapeutic shoe is a feasible way to off-load and heal forefoot ulcers. A controlled trial is needed to compare the effectiveness and safety of a sealed shoe to other non-removable devices.