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BACKGROUND:Diabetic foot ulceration is a severe complication of diabetes characterized by chronic inflammation and impaired wound healing. This study aims to evaluate the effect of a medical device gel based on Adelmidrol + Trans traumatic acid in the healing process of diabetic foot ulcers. METHODS: Thirty-seven diabetic patients with foot ulcers of mild/moderate grade were treated with the gel applied daily for 4 weeks on the affected area. The following parameters were evaluated at baseline and weekly: a) wound area, measured drawing a map of the ulcer then calculated with Photoshop6 tools, b) clinical appearance of the ulcer, assessed recording the presence/absence of dry/wet necrosis, infection, fibrin, neoepithelium, exudate, redness, granulation tissue. RESULTS: Topical treatment led to progressive healing of diabetic foot ulcers with a significant reduction of the wound area and an improvement in the clinical appearance of the ulcers. No adverse events treatment-related were observed. CONCLUSIONS: The results of this open-label study show the potential benefits of Adelmidrol + Trans traumatic acid topical administration to promote re-epithelialization of diabetic foot ulcers. Further studies need to confirm the observed results.
BACKGROUND: Normative studies on the Arch Height Index (AHI), Arch Rigidity Index (ARI), and arch stiffness have primarily focused on healthy populations, with little consideration of pathology. The purpose of this study was to create a normative sample of the aforementioned measurements in a pathological sample and to identify relationships between arch structure measurements and pathology. METHODS: AHI was obtained bilaterally at 10% and 90% weightbearing conditions using the Arch Height Index Measurement System (AHIMS). ARI and arch stiffness were calculated using AHI measurements. Dependent t-tests compared right and left, dominant and non-dominant, and injured and non-injured limbs. Measurements of the dominant foot were compared between sexes using independent t-tests. Relationships between arch stiffness and age, sex, and AHI were examined using the coefficient of determination (R2). One-way ANOVAs were used to determine differences between arch structure measurements and number of pathologies or BMI. RESULTS: A total of 110 participants reported either one (n=55), two (n=38), or three or more (n=17) pathologies. Plantar fasciitis (n=31) and hallux valgus (n=28) were the most commonly reported primary concerns. AHI, ARI, and arch stiffness did not differ between limbs for any comparisons, nor between sexes. Between subgroups of BMI and number of pathologies, no differences exist in AHI or ARI; however, BMI was found to have an impact on AHI (10%WB) and arch stiffness (p<.05). Arch stiffness showed a weak relationship to AHI, where a higher AHI was associated with a stiffer arch (R2=0.06). CONCLUSIONS: Normative AHI, ARI and arch stiffness values were established in a pathological sample with a large incidence of plantar fasciitis and hallux valgus. Findings suggest relationships between arch stiffness and both BMI and arch height; however, few trends were noted in AHI and ARI. Determining relationships between arch structure and pathology is helpful for both clinicians and researchers.
Background: Foot dimension information is important both for footwear design and clinical applications. In recent years, non-contact three-dimensional foot digitizers/scanners became popular as they are non-invasive and are both valid and reliable for the most of measures. Some of them also offer automated calculations of basic foot dimensions. The study aimed to determine test-retest reliability, objectivity, and concurrent validity of the Tiger full foot 3D scanner as well as the relationship between the manual measures of the medial longitudinal arch of the foot and its alternative parameters obtained automatically by the scanner. Methods: Intraclass correlation coefficients and the values of minimal detectable change were used to assess the reliability and objectivity of the scanner. Concurrent validity and the relationship between the arch height measures were determined by the Pearson's correlation coefficient and the limits of agreement between the scanner and the calliper method. Results: Both the relative and absolute agreement between the repeated measurements obtained by the scanner show excellent reliability and objectivity of linear measures and only good to nearly good test-retest reliability and objectivity of the arch height. Correlations between the values obtained by the scanner and the calliper were generally higher in linear measures (rp{greater than or equal to}0.929). The representativeness of state of bony architecture by the soft tissue margin of the medial foot arch demonstrate the lowest correlations among the all measurements (rp{less than or equal to}0.526). Conclusions: The Tiger full foot 3D scanner offers both excellent reliability and objectivity in linear measures, which correspond to those obtained by the calliper method. However, values obtained by the both methods shouldn't be used interchangeably. The arch height measure is less accurate, which could limit its use in some clinical applications. Orthotists and related professions probably appreciate scanner more than other specialists.
Toenail onychomycosis is a common condition that is equally challenging for podiatrists and patients. This case study documents a 26-year-old woman with bilateral total dystrophic onychomycosis of at least 5 years' duration. She had previously failed to respond to treatment with ciclopirox nail lacquer 8% and despite hiding her condition with nail polish, was suffering from embarrassment, distress and low self-esteem. At initial consult, one hundred percent of both great toenails were affected. After discussion of all treatment options, the patient opted for topical efinaconazole 10% solution, once daily for 48 weeks. Significant improvement was noted at the first (4 week) assessment period. This improvement was maintained through each subsequent virtual consult and complete cure was seen at a 30-week follow-up visit. To the author's knowledge this is the first published report on the use of efinaconazole in total dystrophic onychomycosis. It suggests that the product may be effective in patients with even the most severe and treatment recalcitrant disease, who are unwilling or unable to tolerate systemic antifungal therapy.
Background: Syndesmosis is an important soft tissue component supporting the ankle stability and commonly injured accompanying with ankle fractures. The accurate reduction and fixation of syndesmosis is essential to obtain better functional results. Therefore, we aimed to find a practical method using the mortise view of ankle to determine the optimal syndesmosis fixation angle intraoperatively. Methods: We randomly selected 200 adults (100 women and 100 men) between 18 - 60 years of age. Three-dimensional anatomical models of tibia and fibula were created using Materialise MIMICS 21. We created a best fit plane on articular surface of medial malleolus and a ninety degrees vertical plane to medial malleolus plane. We determined two splines on cortical borders of tibia and fibula distant from the most superior point of ankle joint in horizontal view. We created two spheres that fit to the predefined splines. The optimal syndesmosis fixation angle was determined measuring the angle between the line connecting the center points of spheres, and the ninety degrees vertical plane to medial malleolus plane. Results: We observed no statistically significant difference between gender groups in terms of optimal syndesmosis fixation angles. The mean age of our study population was 47.1 {plus minus} 10.5. The optimal syndesmosis fixation angle according to mortise view was found as 21 {plus minus} 4.3 degrees. Conclusions: We determined the optimal syndesmosis fixation angle as 21 {plus minus} 4.3 degrees in accordance with the mortise view of ankle. The surgeon could evaluate the whole articular surface of ankle joint with the medial and lateral syndesmotic space in mortise view accurately and at the same position syndesmosis fixation could be performed at 21 {plus minus} 4.3 degrees.
Vaporous Hyperoxia Therapy (VHTTM), a patented FDA-510 (k) cleared technology, is an adjunct therapy used in conjunction with standard wound care (SWC). VHT is said to improve the health of wounded tissue by administering a low-frequency, non-contact, non-thermal ionic anti-microbial hydrating mist alternating with concentrated topical oxygen therapy (TOT). VHT was used to treat 36 subjects with chronic diabetic foot ulcers (DFUs) that were previously treated unsuccessfully with SWC. The average age of DFU in the study was 11 months old and the average size was over 3 cm2. Wounds were either Wagner Grade 2 or 3 and most commonly on the plantar surface around the midfoot. Treatment consisted of twice weekly applications of VHT and wound debridement. Subjects were followed to wound closure, 20 weeks, or 40 treatments, whichever came first. The combination of SWC and VHT in the group that met and maintained compliance throughout the study period achieved an 83% DFU closure rate within a 20-week time period. The average time for DFU closure in this study was 9.4 weeks. Historical analysis of SWC shows a 30.9% healing rate of all wounds, not differentiating chronic wounds. Accordingly, SWC/VHT increases chronic diabetic foot ulcer healing rates by 2.85 times compared with SWC alone. The purpose of this study was two-fold: first, to observe the effect of VHT on healing rates and time to healing in previously nonhealing DFUs and second, to compare VHT with SWC, TOT and hyperbaric oxygen therapy (HBOT) and ultrasound therapies.
Background: To evaluate clinicians' compliance to follow national guidelines for tetanus vaccination prophylaxis in high-risk foot patients. Methods: We retrospectively evaluated 114 consecutive patients between June 2011 and March 2019 who presented with a foot infection resulting from a puncture injury through the emergency department. Eighty-three patients had diabetes mellitus and 31 patients did not have diabetes mellitus. Electronic medical records were used to collect a broad range of study data on patient demographics, previous medical history, previous tetanus immunization history and tetanus status upon presentation to the emergency department (ED), peripheral arterial disease, sensory neuropathy, laboratory values, and clinical / surgical outcomes. Results: 46.5% of the patients who presented to the ED with a puncture wound did not have up-to-date tetanus immunization. Of those patients, 79.2% received a tetanus-containing vaccine booster, 3.8% received intramuscular tetanus immunoglobulins (TIG), 3.8% received both tetanus-containing vaccine booster and TIG, and 20.8% received no form of tetanus prophylaxis. When comparing data between patients with and without diabetes, there were no statistical significant differences in tetanus prophylaxis. Conclusion: Guidelines for tetanus prophylaxis amongst high-risk foot patients in this study center are not followed in all patients. Patients with DM are at high risks of exposure to tetanus, we recommend physicians to take a detailed tetanus immunization history and vaccinate them if tetanus history is unclear.
Background: Diabetic foot ulcers (DFUs) are main cause of hospitalizations and amputations in diabetic patients. Failure of standard foot care is the most important cause of impaired DFUs healing. Dakin's solution (DS; sodium hypochlorite) is a promising broad spectrum bactericidal antiseptic for DFUs management. Studies investigating the efficacy of using DS solution on DFUs healing process are scarce. Accordingly, this is the first evidence based randomized control trial study conducted to evaluate the effect of using diluted DS compared with the standard care in the management of infected DFUs. Methods: Randomized control trial study was conducted to assess the efficacy of DS in the management of infected DFUs. Patients were randomly distributed to control group (DFUs irrigated with normal saline) and intervention group (DFUs irrigated with 0.1% DS). Patients were followed for at least 24 weeks for healing, reinfection or amputations. In-vitro antimicrobial testing on DS was performed including determination of its minimum inhibitory concentration (MIC), minimum bactericidal concentration (MBC), minimum biofilm inhibitory concentration (MBIC), minimum biofilm eradication concentration (MBEC) and suspension test. Results: Replacing normal saline irrigation in DFU standard care with 0.1% DS followed by soaking the ulcer with commercial sodium hypochlorite (0.08 %) after patient discharge significantly improved ulcer healing (p< 0.001) and decreased number of amputations and hospitalizations (p< 0.001). The endpoint of death from any cause (RR 0.13; p = 0.029) and the amputation rate (RR 0.27; p<0.001) were also significantly reduced. The effect on ulcer closure (OR 11.9; p<0.001) was significantly enhanced in comparison to the control group. Moreover, DS irrigation for inpatients, significantly decreased bacterial load (p< 0.001), The in-vitro analysis results of DS were: MIC (1.44%), MBC (2.88%), MBIC (1.08%) and MBEC (2.87%). Conclusions: Compared with standard care, diluted DS (0.1%) was more effective in the management of infected DFUs. DS (0.1%) irrigation with debridement followed by standard care is a promising method in the management of infected DFUs.
Background: Onychomycosis is a chronic fungal nail infection caused predominantly by dermatophytes, and less commonly by non-dermatophyte molds (NDMs) and Candida species. Onychomycosis treatment includes oral and topical antifungals, the efficacy of which is evaluated through randomized, double-blinded, controlled trials (RCTs) for USA FDA approval. The primary efficacy measure is complete cure (complete mycological and clinical cure). The secondary measures are clinical cure (usually {less than or equal to}10 % involvement of target nail) and mycological cure (negative microscopy and culture). Some lasers are FDA-approved for the mild temporary increase in clear nail; however, some practitioners attempt to use lasers to treat and cure onychomycosis. Methods: A systematic review of the literature was performed in July 2020 to evaluate the efficacy rates demonstrated by RCTs of laser monotherapy for dermatophyte onychomycosis of the great toenail. Results: RCTs assessing the efficacy of laser monotherapy for dermatophyte toenail onychomycosis are limited. Many studies measured cure rates via nails instead of patients, and performed only microscopy or culture, not both. Only one included study reported mycological cure rate in patients as negative light microscopy and culture (0%). The combined clinical cure rates in short- and long-pulsed laser studies were (13.0-16.7% and 25.9%, respectively). There was no study that reported the complete cure rate, however, one did report treatment success (mycological cure (negative microscopy and culture) and {less than or equal to}10% clinical involvement) in nails as 16.7%. Conclusions: The effectiveness of lasers as a therapeutic intervention for dermatophyte toenail onychomycosis is limited based on complete, mycological, and clinical cure rates. However, it may be possible to use different treatment parameters or lasers with a different wavelength to increase the efficacy. Lasers could be a potential management option for older patients and onychomycosis patients with coexisting conditions such as diabetes, liver and/or kidney diseases for whom systemic antifungal agents are contraindicated or have failed.