Effectiveness of saline water and lidocaine injection treatment of intractable plantar keratoma: a randomised feasibility study.

BACKGROUND: An intractable plantar keratoma (IPK) is a conical thickening of the epidermis' stratum corneum and a common cause of foot pain which can have a significant, detrimental impact on the mobility, quality of life and independence of individuals. Conservative treatments are currently offered to patients with IPK, but they are unsatisfactory since they do not offer a sufficient or permanent reduction of symptoms. The purpose of this study was the evaluation of the feasibility, safety and effectiveness of innovative treatments for intractable plantar keratoma (IPK). METHODS: A randomized single blind trial with 40 patients divided with block randomization in four parallel groups was conducted to compare treatment combinations: conservative sharp debridement only or sharp debridement with needle insertion, physiological water injection or lidocaine injection. All patients obtained the same treatment four times at a four-week interval. At each visit, visual analog scale (VAS), Foot Function Index (FFI) and IPK size were evaluated. VAS and FFI were also completed at a six and twelve-month follow-up. RESULTS: Our findings in regards to feasibility demonstrated recruitment challenges because of the anticipated pain that would be provoked by needle insertion may not be worth the potential pain relief compared to debridement alone from the patient's perspective. This was also the principal cause of drop out. Our preliminary results show no main effect of group for any of the clinical outcomes: pain felt on VAS, FFI score, IPK's size (p > 0.05). However, the analysis revealed a statistically significant effect of time on VAS (p < 0.001), FFI score (p < 0.001) and IPK's size (width and depth (p < 0.001); length (p = 0.001)), but no group x time interaction was found (p > 0.05). CONCLUSIONS: This study demonstrates that IPK treatment consisting of sharp debridement with needle insertion, physiological saline water injection or lidocaine injection is feasible and safe. There was a non-statistically significant trend toward diminishing pain intensity compared to scalpel debridement alone. The pain provoked by needle insertion and injection treatments must be addressed with a scientifically proven protocol to make it more comfortable for patients before these treatments could be considered in further studies. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04777227 . 2 March, 2021 - Retrospectively registered (All participants were recruited prior to registration).

Quality of Diabetic Foot Ulcer Care: Evaluation of an Interdisciplinary Wound Care Clinic Using an Extended Donabedian Model Based on a Retrospective Cohort Study.

OBJECTIVES: Diabetic foot ulcer (DFU), a serious complication of diabetes, is associated with increased morbidity and mortality and presents a substantial socioeconomic burden. However, DFU quality of care has been insufficiently studied. Therefore, the aim of this study was to evaluate the quality of DFU care at an interdisciplinary wound care clinic in Canada, based on an extended Donabedian model: structure, process and outcome quality indicators combined with patient characteristics. METHODS: This was a retrospective cohort study of 140 adult patients with diabetes who were treated between 2012 and 2018 at a wound care clinic in a university-affiliated hospital in the Québec City area of Canada. Twenty-two internationally recognized quality-of-care indicators were identified from the literature. Data were collected from medical files, and the results were used to document the selected quality-of-care indicators. RESULTS: The principal indicators regarding structure and process were met, and outcome indicators were influenced by study population characteristics, particularly peripheral artery disease and critical limb ischemia. Moreover, this study highlights that quality-of-care indicators are essential when evaluating DFU outcomes, as structure and process indicators can also affect wound healing outcomes. CONCLUSIONS: This study suggests that DFU care at a Canadian wound care clinic, with an interdisciplinary approach, meets most quality-of-care indicators. The socioeconomic burden of DFUs for patients, health-care organizations and policymakers, and the paucity of quality and performance evaluations, call for more studies evaluating DFU care.

Outcomes and prognosis of diabetic foot ulcers treated by an interdisciplinary team in Canada.

The aim of this study was to determine the wound healing outcomes of patients with a plantar diabetic foot ulcer (DFU) treated with an interdisciplinary team approach, and to identify associated variables. A retrospective observational cohort study of 140 adult patients, with a plantar DFU, treated between 2012 and 2018 at a wound care clinic of a University affiliated hospital was conducted. Predictive and explicative analyses were conducted with logistic multivariate methods and with a Receiver Operating Characteristics curve. The best predictor of wound healing at 3 months was a 41.8% wound size reduction at 4 weeks (AUC: 0.86; sensitivity: 83.1%; specificity: 67.2%, positive predictive value: 72.8%; negative predictive value: 78.9%; positive and negative likelihood ratios: 2.53 and 0.25, respectively). Main baseline variables independently associated with this predictor were: a monophasic Doppler waveform (OR 7.52, 95% CI [2.64-21.39]), cigarette smoking (OR 4.7, 95% CI [1.44-15.29]), and male gender (OR 3.58, 95% CI [1.30-9.87]). The health care provider should be cautious and intensify its management of DFUs particularly with patients of male gender; smoking, having a monophasic waveform with a hand-held Doppler, and not achieving a minimal 41.8% wound area reduction at 4 weeks of treatment.