Treatment of Diabetic Foot Ulcers With Inforatio Technique to Promote Wound Healing: A Feasibility Trial.

Chronic foot ulcers have extensive consequences for diabetic patients' quality of life and increase risks of amputation and death. The aim of this trial was to assess the feasibility of conducting a larger clinical trial to evaluate the clinical effect of inforatio technique on healing of diabetic foot ulcers (DFUs). Inforatio technique is a novel minimal invasive procedure where small cuts are made on wound beds with punch biopsy tools. This study was a feasibility trial conducted at an outpatient wound care clinic at Zealand University Hospital. Twelve patients with DFUs were included. During a 90-day follow-up, participants visited the clinic 5 times and received inforatio technique twice. Feasibility was assessed with regard to recruitment, acceptability, burden, benefits, protocol adherence, and adverse events. The recruitment rate was 1 patient per eighth day (95% confidence interval [CI] = [4th-13th]), and the retention rate was 100% (95% CI = [74-100]). During follow-up, healing was observed for 4 ulcers (33%, 95% CI = [10-65]) with a mean time for healing of 59 days (range, 22-89) (95% CI = [5-113]). Five ulcers had a reduction of wound area and 3 ulcers had an increase in area from baseline to 90-day follow-up. No temporal relationship was found between inforatio application and wound area increase. There were no patient-reported harmful effects and no adverse events with probable relation to inforatio technique. Patient acceptability and participant adherence were promising. Thus, a larger clinical trial for evaluating the clinical effect of inforatio technique is considered feasible to conduct.

Inforatio technique to promote wound healing of diabetic foot ulcers: study protocol for a parallel-group, evaluator-blinded, randomised clinical trial.

INTRODUCTION: Diabetic foot ulcers (DFUs) are associated with extensive consequences for the affected patients and treatment of these hard-to-heal ulcers is known for being challenging. New treatment methods to supplement the current standard care may improve the prognosis for these patients.A preceding feasibility trial with promising results, facilitated this trial that aims to study the effect of a novel simple treatment, called inforatio technique, which may promote healing of DFUs. The inforatio technique is a minimally invasive procedure where small cuts are made on wound beds with punch biopsy tools. METHODS AND ANALYSIS: This multicentre randomised clinical trial will be conducted at outpatient clinics at Zealand University Hospital, Herlev University Hospital, Slagelse Hospital and Nykoebing Falster Hospital. 100 participants will be included and randomised in a 1:1 ratio to either a control group that receives usual care or an intervention group that receives both usual care and the inforatio technique.The primary outcome is complete healing evaluated on digital images by blinded observers. It is not possible to blind participants or the outpatient clinic staff because the inforatio technique is visible in wound beds after application. Change in EQ-5D-5L (EuroQoL-5 Dimension- 5 Level) Visual Analogue Scale Score and Wound-QoL Global Score from baseline to end of follow-up are secondary outcomes. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Danish National Committee on Health Research Ethics on 15 December 2021 (approval ID: SJ-904). Trial results are planned to be published in a high-impact peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT05189470.

Benefits and Harms of Exercise Therapy for Patients With Diabetic Foot Ulcers: A Systematic Review.

AIM: Exercise therapy is a core element in the treatment of diabetes, but the benefits and harms for patients with a diabetic foot ulcer (DFU) are unknown. We therefore aimed to systematically review the benefits on health-related quality of life (HRQoL) and harms of exercise therapy for patients with DFU. METHODS: We searched 6 major databases. We performed citation and reference searches of included studies and contacted authors of ongoing trials. We included randomized controlled trials (RCTs) to assess potential benefits on HRQoL and harms of exercise therapy. Observational studies were included to identify potential harms of exercise therapy. RESULTS: We included 10 published publications of 9 trials and results from 2 unpublished trials including a total of 281 individuals with DFUs receiving various forms of exercise therapy. Due to lack of HRQoL measurements and high heterogeneity, it was not possible to perform meta-analyses. Results on HRQoL was present in one unpublished study. Harms reported ranged from musculoskeletal problems, increased wound size, to amputation; however, no safe conclusions could be drawn from the available data due to high heterogeneity and risk of bias in the trials. CONCLUSIONS/INTERPRETATION: Protective strategies are often preferred over therapeutic exercise that might have unforeseen consequences for patients over time. Based on the current literature, no evidence-based recommendations can be provided on the benefits and harms of exercise therapy for patients with DFUs. Well-conducted RCTs are needed to guide rehabilitation including detailed description of adverse events and an exercise program in a semisupervised or fully supervised setting.

Rasch analysis of the Western Ontario Osteoarthritis of the Shoulder index - the Danish version.

PURPOSE: The Western Ontario Osteoarthritis of the Shoulder (WOOS) index is a disease-specific, patient-reported, 19-question survey that measures the quality of life among patients with osteoarthritis (OA). The purpose of this study was to validate the Danish version of WOOS for OA and fractures (FRs) using modern test theory. PATIENTS AND METHODS: The study included 1,987 arthroplasties in 1,943 patients that were reported to the Danish Shoulder Arthroplasty Register between 2006 and 2011. These included 847 OA and 1,140 FR cases. RESULTS: Principal component analysis indicated the unidimensionality of WOOS. The person reliabilities showed a floor-ceiling effect, indicating that a dichotomy was the best fit for the WOOS scale. For OA, WOOS showed good reliability (item and person reliability of 0.98 and 0.76) and good targeting, with a person mean of -0.56 logits. FR also showed good targeting (person mean of -0.08) and good reliability (item and person reliabilities of 1.00 and 0.86, respectively). All WOOS items fit well with the OA sample except items 5 and 6 (pertaining to grinding and the influence of weather). In addition, item 6 showed signs of degrading the scale with an outfit mean square of 2.46. Only item 6 showed a misfit for FR with no sign of scale degradation. The residual principal component analysis confirmed the unidimensionality of FR but not OA. Six items displayed clinically significant differential item functioning between OA and FR. CONCLUSION: Rasch analysis showed that WOOS had a good fit with the Rasch model when used as a dichotomous scale for OA and FR. However, the results were valid only when WOOS was divided into two categories with a threshold of 950 (50% of the maximum score). For the use of WOOS in future clinical research, we recommend that a dichotomous score be reported as a measure of clinical failure in OA and FR.