2. Materials and Methods
lower limb amputation, DFUs, cognitive impairment, Charcot neuroarthropathy, infection, psychiatric, ulcer
ULCER, DIABETES MELLITUS, BEST, INFECTION, PERIPHERAL NEUROPATHY
This manuscript presents preliminary qualitative findings from an ongoing parallel randomized control trial (ClinicalTrials.gov Identifier: NCT04460573) to investigate the influence of a sensorized offloading walker on health outcomes in people with DFUs, termed Smart Monitoring of patient Activity via Remote Technologies for Best Optimizing Offloading Therapy (SMARTBOOT). All participants signed an approved consent form before enrolling in this study. The study protocol and consent form were approved by the University of Southern California Institutional Review Board (protocol number: HS-20-00526). A computer-generated list (MATLAB software) randomly assigned participants in a 1:1:1 ratio to one of three offloading device groups: (1) irremovable cast walker (iRCW, reference group), (2) original removable cast walker (oRCW, control group), or (3) smart removable cast walker (sRCW, intervention group). The offloading component was identical between groups and only the method for managing adherence was different. All participants wore their offloading device for 12 weeks, or until their ulcer was deemed healed by a physician. Participants were recruited from the Keck School of Medicine (Los Angeles Metropolitan, CA, USA). To be included in the study, individuals had to be over 18 years of age, have diabetes mellitus, have a plantar ulcer, have evidence of peripheral neuropathy, and be ambulatory at home with or without assistance, and be willing and able to provide informed consent. Individuals were excluded from participating in the study if they had major foot deformity so that the patient could not fit to standard offloading (e.g., Charcot neuroarthropathy), active infection, major lower limb amputation, changes in psychotropic or sleep medication in the last 6 weeks, any clinically significant medical or psychiatric condition, severe cognitive impairment, or laboratory abnormality that would interfere with the ability to participate in the study. Additionally, individuals were excluded from participating in the study if they were being considered for revascularization during the study, concurrently participating in exercise training, or unable or unwilling to attend prescribed clinic visits or comply with protocol. Only participants who completed all self-report data (TAM and all participant characteristics reported in this manuscript) were included in the analysis. Study groups are depicted in The sRCW and its validity were described in detail in our prior publication on healthy controls [Participants completed the following patient-reported outcomes: the Montreal Cognitive Assessment (MoCA) to assess cognition [To assess perspectives on device acceptability, participants also completed a 15-item questionnaire based on the Technology Acceptance Model (TAM) [Participants who reported identifying as Hispanic or Latino were classified as Hispanic or Latino, while those who did not were classified as Non-Hispanic or Latino. Additionally, participants who reported experiencing at least one fall in the past 12 months were categorized as fallers, while those who did not report experiencing any falls in the past 12 months were categorized as non-fallers.Spearman correlations were performed to determine associations between participant characteristics and TAM ratings. Chi-squared tests of independence were performed to examine the relationship between TAM ratings with ethnicity (Hispanic or Latino, Non-Hispanic or Latino), as well as TAM ratings with 12-month retrospective fall status (faller, non-faller). All statistical analyses were performed using IBM SPSS Statistics 25 (IBM, Chicago, IL, USA). Statistical significance in all tests was considered to be a 2-sided 