People suffering from diabetes are at risk of developing foot ulcerations, which, if left untreated, could also lead to amputation. Monitoring of the foot temperature can help in the prevention of these foot complications, and various studies have shown that elevated temperatures may be indicative of ulceration. Over the years there have been various devices that were designed for foot temperature monitoring, both for clinical and home use. The technologies used vary from infrared (IR) thermometry, liquid crystal thermography (LCT), IR thermography and a vast range of analogue and digital temperature sensors that were incorporated in different measurement platforms. All these systems are able to collect thermal data from the foot, some being able to acquire data only when the foot is stationary and others being able to acquire from the foot in motion, which can give a more in-depth insight to any emerging problems. The aim of this review is to evaluate the available literature related to the technologies used in these systems, outlining the benefits of each and what further developments may be required to make the foot temperature analysis more effective.
Background: Diabetic foot ulceration is a severe complication of diabetes characterized by chronic inflammation and impaired wound healing. This study aimed 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 daily for 4 weeks on the affected area. The following parameters were evaluated at baseline and weekly: 1) wound area, measured by drawing a map of the ulcer and then calculated with photo editing software tools, and 2) clinical appearance of the ulcer, assessed by recording the presence/absence of dry/wet necrosis, infection, fibrin, neoepithelium, exudate, redness, and 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 treatment-related adverse events were observed.
Conclusions: The results of this open-label study show the potential benefits of adelmidrol + trans-traumatic acid topical administration to promote reepithelialization of diabetic foot ulcers. Further studies are needed to confirm the observed results.
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: Onychomycosis is a chronic fungal nail infection caused predominantly by dermatophytes, and less commonly by nondermatophyte molds and Candida species. Onychomycosis treatment includes oral and topical antifungals, the efficacy of which is evaluated through randomized, double-blind, controlled trials for US Food and Drug Administration approval. The primary efficacy measure is complete cure (complete mycologic and clinical cure). The secondary measures are clinical cure (usually ≤10% involvement of target nail) and mycologic cure (negative microscopy and culture). Some lasers are US Food and Drug Administration 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 of 2020 to evaluate the efficacy rates demonstrated by randomized controlled trials of laser monotherapy for dermatophyte onychomycosis of the great toenail.
Results: Randomized controlled trials assessing the efficacy of laser monotherapy for dermatophyte toenail onychomycosis are limited. Many studies measured cure rates by means of nails instead of patients, and performed only microscopy or culture, not both. Only one included study reported mycologic 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 (mycologic cure [negative microscopy and culture] and ≤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, mycologic, 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.
Laser systems are a new treatment area for onychomycosis. As of January 2012, the US Food and Drug Administration (FDA) has approved four laser systems for the “temporary increase of clear nail in onychomycosis.” The FDA has approved these devices on the basis of “substantial equivalence” to predicate devices with similar technical specifications and applications. Laser therapy appears to be a promising alternative to traditional pharmacotherapy, but these systems have been tested in only limited clinical trials; therefore, it is not possible to compare their efficacy to the oral and topical drugs currently used in the treatment of onychomycosis. (J Am Podiatr Med Assoc 102 (5): 428-430, 2012)
The increasing resistance of bacteria to antibiotics and the frequency of comorbid conditions of patients make the treatment of diabetic foot infections problematic. In this context, photodynamic therapy could be a useful tool to treat infected wounds. The aim of this study was to evaluate the effect of repeated applications of a phthalocyanine derivative (RLP068) on the bacterial load and on the healing process.
The present analysis was performed on patients with clinically infected ulcers who had been treated with RLP068. A sample for microbiological culture was collected at the first visit before and immediately after the application of RLP068 on the ulcer surface, and the area was illuminated for 8 minutes with a red light. The whole procedure was repeated three times per week at two centers (Florence and Arezzo, Italy) (sample A), and two times per week at the third center (Stuttgart, Germany) (sample B) for 2 weeks.
Sample A and sample B were composed of 55 and nine patients, respectively. In sample A, bacterial load decreased significantly after a single treatment, and the benefit persisted for 2 weeks. Similar effects of the first treatment were observed in sample B. In both samples, the ulcer area showed a significant reduction during follow-up, even in patients with ulcers infected with gram-negative germs or with exposed bone.
RLP068 seems to be a promising topical wound management procedure for the treatment of infected diabetic foot ulcers.
We reviewed the use of compression staples made of the memory metal alloy nitinol for fixation in foot surgery. A retrospective study was performed of 31 feet in 27 patients who underwent arthrodesis or an osteotomy fixated using compression staples. OSStaples (BME, San Antonio, Texas) were used in 18 feet, and Memodyn staples (Telos Medical, Fallston, Maryland) were used in 13 feet. A total of 48 compression staples were implanted. The following procedures were performed and fixated using compression staples: 15 Akin osteotomies, 2 first metatarsal base epiphysiodeses, 3 first metatarsal–cuneiform fusions, 2 naviculocuneiform fusions, 3 calcaneocuboid fusions, 4 talonavicular fusions, 3 subtalar joint fusions, and 2 Evans osteotomies. In our clinical experience, compression staples provide an adequate source of internal fixation in foot surgery. Good bone apposition and stabilization and compression of the bone surfaces before staple fixation are important when using staple fixation to promote an optimal environment for bone healing. (J Am Podiatr Med Assoc 96(2): 102–106, 2006)
Recently, there has been a resurgence of interest in potential phototherapy technologies for the local treatment of bacterial and fungal infection. Currently, onychomycosis is the principle disease that is the target of these phototherapies in podiatric medicine. Some of these technologies are currently undergoing in vitro and in vivo trials approved by institutional review boards. The three light-based technologies are ultraviolet light therapy, near infrared photo-inactivation therapy, and photothermal ablative antisepsis. Each of these technologies have markedly dissimilar mechanisms of action. In this review, each technology will be discussed from the perspectives of history, photobiology, individual mechanism of action, safety, and potential clinical efficacy, with data presented from published material. This review is intended to give podiatric physicians detailed information on state-of-the-art infectious disease phototherapy. (J Am Podiatr Med Assoc 99(4): 348–352, 2009)
The number of people with diabetes is expected to reach 592 million in the year 2035. Diabetic foot lesions are responsible for more hospitalizations than any other complication of diabetes. The aims of this study were to examine for the first time a new biocompatible and biodegradable tridimensional collagen-based matrix, GBT013, in humans for diabetic foot ulcer wound healing and to evaluate its ease of use to better define a protocol for a future clinical trial. Seven adult patients with a diabetic foot ulcer of grade 1A to 3D (University of Texas Diabetic Wound Classification) were treated using GBT013, a new collagen-based advance dressing and were monitored in two specialized foot care units for a maximum of 9 weeks. Five of seven wounds achieved complete healing in 4 to 7 weeks. Nonhealed ulcers showed a significant reduction of the wound surface (>44%). GBT013 was well tolerated and displayed positive wound healing outcomes as a new treatment strategy of chronic foot ulcers in diabetic patients.
Background: The Noveon is a unique dual-wavelength near-infrared diode laser used to treat onychomycosis. The device operates at physiologic temperatures that are thermally safe for human tissue. It uses only 870- and 930-nm near-infrared light, wavelengths that have unique photolethal effects on fungal pathogens. These wavelengths lack the teratogenic danger presented by ultraviolet light and the photoablation toxic plume associated with pulsed Nd:YAG lasers.
Methods: In this randomized controlled study, treatments followed a predefined protocol and laser parameters and occurred on days 1, 14, 42, and 120. Toes were cultured and evaluated, and measurements were taken from standardized photographs obtained periodically during the 180 day follow-up period.
Results: We treated mycologically confirmed onychomycosis in 26 eligible toes (ten mild, seven moderate, and nine severe). All of the patients were followed-up for 180 days. An independent expert panel, blinded regarding treatment versus control, found that at 180 days, 85% of the eligible treated toenails were improved by clear nail linear extent (P = .0015); 65% showed at least 3 mm and 26% showed at least 4 mm of clear nail growth. Of the 16 toes with moderate to severe involvement, ten (63%) improved, as shown by clear nail growth of at least 3 mm (P = .0112). Simultaneous negative culture and periodic acid–Schiff was noted in 30% at 180 days.
Conclusions: These results indicate a role for this laser in the treatment of onychomycosis, regardless of degree of severity. Ease of delivery and the lack of a need to monitor blood chemistry are attractive attributes. (J Am Podiatr Med Assoc 100(3): 166–177, 2010)