Oral session 6: Biomechanics and offloading O6.1 Do diabetic foot ulcers affect daily activity, energy expenditure and sleep? Helen Sheahan, Queensland Health, Brisbane, Australia Kimberley Canning, Queensland Health, Brisbane, Australia Nishka Refausse, Queensland Health, Brisbane, Australia Ewan Kinnear, Queensland Health, Brisbane, Australia Betty Mulder, Queensland Health, Brisbane, Australia Greg Jorgensen, Queensland Health, Brisbane, Australia James Walsh, Queensland Health, Brisbane, Australia Peter Lazzarini, Queensland University of Technology, Brisbane, Australia Aim: Very few studies have investigated daily activity, energy expenditure and sleep in people with active diabetic foot ulcers (DFU)., The aim of this case-control study was to investigate daily activity, energy expenditure and sleep in people with DFU compared to those with diabetes and no history of DFU. Methods: Participants with type 2 diabetes were recruited into three groups: i) current neuropathic foot ulcers (DFU), ii) peripheral neuropathy without DFU history (DPN), iii) nil peripheral neuropathy or DFU history (DNIL)., Exclusion criteria included peripheral arterial disease and mobility aid use., Participants wore a multi-sensor SenseWear Pro 3 Armband device continuously for 7 days and completed an Epworth Sleepiness Scale., The Armband is a validated automated measure of free-living daily activity (steps, Metabolic Equivalent Tasks (MET), physical activity (>3 METs) duration), energy expenditure(kJ) (total and physical activity (>3 METs)) and sleep (duration)., Data on age, sex, BMI, diabetes duration and HbA1c were also collected. Results: Sixty-six (30 DFU, 22 DPN and 14 DNIL) participants were recruited; mean±SD age 61±12 years, 71% males, BMI 32.6±5.9, diabetes duration 13±9 years, HbA1c 8.4±4.2, and average METs 1.2±0.2., No significant demographic differences were reported between groups (p > 0.2); except for mean age (57±11 DFU, 68±9 DPN; 58±11 NIL; p = 0.001)., Mean steps per day was different between groups: 3 271±2 417 DFU, 5 007±3 349 DPN and 5 859±2 381 DNIL (p = 0.01)., Mean daily energy expenditure (kJ) was also different between groups: 13 006± 3 559 DFU, 11 060±1 916 DPN and 10 868±1 307 DNIL (p < 0.02)., No significant differences were reported between groups for average METs, physical activity duration or energy expenditure, sleep time or Epworth score (p > 0.2). Conclusions: Findings indicate people with diabetes and active foot ulcers walk much less, but expend much more energy in doing so than those people with diabetes and no foot ulcer history., Sleep and physical activity parameters showed no differences., Further research is required to investigate safe “activity dosing” and balancing of daily energy demands to optimise wound healing in people with DFU. www.diabeticfoot.nl Page 1 of 5 O6.2 Gait and perceived comfort implications of offloading devices’: size and induced limb length inequality Ryan Crews, Rosalind Franklin University, North Chicago, IL, United States Joseph Candela, Rosalind Franklin University, North Chicago, IL, United States Ghazizadeh Ramin, Rosalind Franklin University, North Chicago, IL, United States Aim: Removable cast walkers (RCW) help heal diabetic foot ulcers (DFU) by offloading the injured foot during weight bearing activities. However, patients’ RCW compliance is often poor. RCW designs give little consideration to the impeded gait or postural instability they induce. This study evaluated how 1) using an elevating device (lift) on the contralateral foot and 2) modifying RCW size, would impact detrimental changes in gait and comfort associated with RCW. Methods: Twenty-five adults at risk for DFU were recruited. Subjects walked a 20m walkway in five different conditions: control (bilateral athletic shoes), short RCW with and without contralateral lift, tall RCW with and without contralateral lift. A 7.3m GaitRite mat recorded spatial and temporal parameters of steps and Pedar-X pressure insoles recorded bilateral pressure data. Subjects rated the comfort of each footwear condition with a 12cm visual analog scale. Results: In comparison to the control condition, the short RCW had a significantly smaller reduction in velocity than the tall RCW (9.5 ±2.8% vs. 15.1±3.0%). The lift did not significantly alter gait velocity. Plantar pressure data indicated the offloaded foot was best offloaded in the tall RCW and no-lift conditions. Conversely, the contralateral foot saw the least pressure in the short RCW and lift conditions. The varied footwear conditions yielded significantly (p<.05) different comfort ratings (Figure 1). Conclusions: The most comfortable footwear condition was the short RCW plus contralateral foot lift. It remains unknown whether the reduced loading of the contralateral foot and improved patient comfort (which may lead to improved RCW compliance) observed in that footwear condition, outweigh the drawback of reduced offloading of the RCW foot. Mean comfort rating for each condition is presented with error bars representing standard deviation values. Each star above a footwear condition indicates a successively lower mean value compared to other conditions (p<.05). sRCW= short RCW; tRCW= tall RCW www.diabeticfoot.nl Page 2 of 5 O6.3 Total contact cast treatment for the diabetic foot; with or without antithrombotic prophylaxis? I.M. Reeder, University Hospital Maastricht, Maastricht, Netherlands R. Sleegers, University Hospital Maastricht, Maastricht, Netherlands M.A. Witlox, University Hospital Maastricht, Maastricht, Netherlands N.C. Schaper, University Hospital Maastricht, Maastricht, Netherlands J.P.S. Hermus, Department of Orthopaedic surgery, Maastricht University Medical Centre, Maastricht, Maastricht, Netherlands Aim: Below knee immobilisation with a cast is according to several studies associated with deep venous thrombosis (DVT), incidence rates up to 19% have been reported1. International guidelines provide contradictory advice about the use of low molecular weight heparin (LMWH) in patients treated with casts2. A total contact cast (TCC) is frequently used in diabetic patients for non-traumatic complications and may result in an increased DVT risk., In our clinic LMWH is not prescribed. Therefore, the aim of this study was to determine the incidence of DVT or other thromboembolic events in diabetic patients treated with a TCC without any antithrombotic therapy. Methods: All patients treated for at least 2 weeks at our outpatient clinic by our multidisciplinary foot-team with a below knee TCC, for a diabetic foot ulcer and/or an acute Charcot, between May 1997 and August 2014 were eligible for inclusion in this retrospective study. Patients with antithrombotic therapy were excluded. The development of a DVT, defined according to international criteria (including echo) or a thromboembolic event during TCC treatment and during 2 months follow-up was objectified using the electronic patient file of the hospital. In case of missing data the general practitioner and/or the patient was contacted. Results: A total of 101 patients (mean age 59 year, 64 male) were analysed. The majority, 73 patients, were treated for more than 6 weeks with a TCC. The total number of persondays of TCC treatment was 10.984, with a median duration of 84 days (interquartile ranges 42-161). Per patient 2.15 episodes of TCC treatment was given of which 0.39 for Charcot, 1.08 for a foot ulcer and 0.68 for the combination of both. No patient experienced a thromboembolic event during treatment or during follow-up. Conclusion: During a total at risk exposure of more than 10.000 TCC days and during 2 months follow-up, no patient experienced a thromboembolic event. The absence of a DVT or other thromboembolic event in diabetic patients treated with TCC suggests that nontraumatic lower limb immobilisation with a TCC is in these patients not an indication for antithrombotic prophylaxis. 1.M.R. Lassen et al. N Engl J Med 2002 Sep 5;347(10):726-30. 2.M.C. Struijk-Mulder et al. J Thromb Haemost 2010;8:678–83. www.diabeticfoot.nl Page 3 of 5 O6.4 Can’t Stand The Pressure: The association between unprotected standing, walking and wound healing Bijan Najafi, University of Arizona, College of Medicine, Tucson, AZ, United States Gurtej Grewal, University of Arizona, College of Medicine, Tucson, AZ, United States Manish Bharara, University of Arizona, College of Medicine, Tucson, AZ, United States Robert Menzies, Hamad Medical Co, Doha, Qatar K. Talal, Hamad Medical Co, Doha, Qatar David Armstrong, University of Arizona, College of Medicine, Tucson, AZ, United States Aims: To report patterns of physical activity and their relationship to wound healing success in patients with diabetic foot ulcers protected with removable or irremovable offloading devices. Methods: Forty-nine patients with plantar neuropathic foot ulcers were randomized to wear either a removable cast walker (RCW) or an irremovable instant total contact cast (iTCC). Primary outcome measures included change in wound size, organization and magnitude of daily activity including position (i.e. sitting, standing, lying) and locomotion (speed, steps, etc.). Outcomes parameters were assessed on weekly basis until wound healing or till 12 weeks. Results: Proportion of healing at 12 weeks was higher in the iTCC, group (p=0.04). Significant differences in activity were observed between groups starting at week 4. RCW patients became more active (75% higher duration of standing, 100% longer duration of walking, and 126% longer continuous walking episode compared to iTCC group (p<0.05 for all). Overall, there was an inverse association between rate of weekly wound healing and number of steps taken per day (r<-0.33, p<0.05) for both groups. However, the RCW group had an even more profound correlation between duration of daily standing and weekly rate of healing (r=-0.67, p<0.05). The duration of standing was the only significant predictor for the success of wound healing at 12 weeks. Conclusion: The results from this study suggest significant and fascinating differences in activity patterns between removable and irremovable offloading devices. These patterns appear to start diverging at week 4, which may indicate decline in adherence to offloading. Results suggest that while walking may delay wound healing, unprotected standing might be an even more silent, sinister culprit. Support: Qatar National Research Foundation, NPRP 4-1026-3-277 www.diabeticfoot.nl Page 4 of 5 O6.5 Development of foot ulcers and amputations in type 2 diabetes mellitus patients without therapeutic footwear: a retrospective claims study Michael Minshall, DJO Global, Vista, CA, United States Emily Durden, Truven Health Analytics, Ann Arbor, MI, United States Donna McMorrow, Truven Health Analytics, Ann Arbor, MI, United States Roy Lidtke, Rush University Medical Center, Chicago, IL, United States Aims: Study purpose was to describe the primary and secondary development of foot ulcers and lower limb amputations in Type 2 Diabetes mellitus (T2DM) patients, without therapeutic footwear, using claims data over a 2-year period. Methods: Inclusion criterion were:1) ≥3 years (1 year before as pre-index, 2 years after a randomly assigned index date) of continuous medical and pharmacy enrollment in a health plan; 2) ≥1 inpatient and/or non-diagnostic outpatient medical claim with a T2DM diagnosis (ICD-9-CM 250.x0 or 250.x2) in the pre-index period; 3) aged >18 years; 4) without or evidence of foot ulcer for the primary (n=21 465) and secondary progression (n=4 792) groups, respectively. Included patients were propensity-score matched to an equal number of T2DM patients with therapeutic footwear claim(s) in order to assess untreated diabetic foot disease. Patients were excluded if they had any claims for therapeutic footwear. Comorbidity and T2DM complication characteristics at baseline and 2 years of follow up are described in Table 1. Results: The primary progression group demonstrated a 5.1% rate of foot ulcers at 2 years while the secondary progression group showed a 42.3% rate of additional foot ulcers at 2 years. The primary progression group demonstrated a 0.4% rate of lower limb amputations at 2 years while the secondary progression group showed a 6.3% rate of additional lower limb amputations at 2 years. Each population demonstrated increases over the 2-year study period in claims for both T2DM comorbidities and complications. Conclusions: The rapid development of foot ulcers and amputations in the primary and secondary progression groups highlight an important opportunity for public health interventions targeted towards foot ulcer and amputation prevention. Primary Primary Secondary Secondary T2DM Comorbidities Baseline 2-Years Baseline 2-Years Cardiovascular Conditions 52.2% 75.5% 67.4% 95.3% Depression 7.1% 12.0% 8.7% 15.8% Hypertension 63.7% 79.8% 71.0% 83.1% Kidney Disease 11.5% 17.6% 19.7% 27.7% Obesity 5.8% 10.5% 10.1% 16.3% Selected T2DM Complications Foot Ulceration 0%* 5.1%** 100%* 42.3%** Polyneuropathy 3.0% 4.5% 9.7% 13.3% Amputations of the lower limb 0.1% 0.4% 8.4% 6.3%* Atherosclerosis 13.2% 15.8% 29.8% 32.4% Diabetic retinopathy 10.5% 13.4% 19.5% 23.9% Diabetic nephropathy 6.5% 9.9% 11.9% 17.8% *Primary and secondary populations were selected for 0% and 100% foot ulcers at baseline, respectively. **Depicts additional foot ulcers and lower limb amputations after baseline. www.diabeticfoot.nl Page 5 of 5
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