EUREKA study - The evaluation of real-life use of a biophotonic system in chronic wound management: An interim analysis

Objective: Interest has grown regarding photobiomodulation (PBM) with low-level light therapy, which has been shown to positively affect the stages of the wound healing process. In a real-life context clinical setting, the objective of the EUREKA study was to investigate efficacy, safety, and quality of life associated with the use of a BioPhotonic gel (LumiHeal\u2122) in the treatment of chronic wounds such as venous leg ulcers (VLUs), diabetic foot ulcers (DFUs), and pressure ulcers (PUs). This BioPhotonic gel represents a new, first-in-class emission spectrum of light, including fluorescence, to induce PBM and modulate healing. Design: The multicenter, prospective, interventional, uncontrolled, open-label study enrolled 100 patients in 12 wound centers in Italy. We performed an early interim analysis based on the first 33 subjects (13 VLU, 17 DFU, 3 PU) in seven centers who completed the study. Main results: Seventeen patients (52%) achieved total wound closure (full re-epithelialization for 2 weeks) during the study period. Two patients (6%) were considered \u201calmost closed\u201d (decrease of the wound area of more than 90% at study end) and three others (9%) were considered \u201cready for skin grafting\u201d. No related serious adverse events were observed, and the compliance was excellent. After the treatment, the average time to \u201cpain-free\u201d was 11.9 days in the VLU group. Quality of life was improved with overall increase of 26.4% of the total score (Cardiff Wound Impact Schedule, p=0.001). Conclusion: The study revealed a positive efficacy profile of the BioPhotonic gel in promoting wound healing and reactivating the healing process in different types of chronic, hard-to-heal wounds. The treatment was shown to be safe and well tolerated by the patients, and a reduction of pain perception was also detected during the treatment period. The improvement of the quality of life was accompanied by a high level of clinician satisfaction

Sensors and Biosensors for C-Reactive Protein, Temperature and pH, and Their Applications for Monitoring Wound Healing: A Review

Wound assessment is usually performed in hospitals or specialized labs. However, since patients spend most of their time at home, a remote real time wound monitoring would help providing a better care and improving the healing rate. This review describes the advances in sensors and biosensors for monitoring the concentration of C-reactive protein (CRP), temperature and pH in wounds. These three parameters can be used as qualitative biomarkers to assess the wound status and the effectiveness of therapy. CRP biosensors can be classified in: (a) field effect transistors, (b) optical immunosensors based on surface plasmon resonance, total internal reflection, fluorescence and chemiluminescence, (c) electrochemical sensors based on potentiometry, amperometry, and electrochemical impedance, and (d) piezoresistive sensors, such as quartz crystal microbalances and microcantilevers. The last section reports the most recent developments for wearable non-invasive temperature and pH sensors suitable for wound monitoring

Synergism of Therapies After Postoperative Autograft Failure in a Patient With Melanoma of the Foot Misdiagnosed as a Pressure Ulcer

Amelanotic melanoma of the foot is a diagnostic challenge for physicians as it often appears as a benign lesion. In order to make the correct diagnosis at early stages, it is recommended to perform a biopsy of worsening lesions that are refractory to standard treatments, particularly nonhealing wounds

Definition of treatment goals in terms of clinician-reported disease severity and patient-reported outcomes in moderate-to-severe adult atopic dermatitis: a systematic review

BACKGROUND: Atopic dermatitis (AD) is a chronically relapsing skin disease. Although a definitive cure is not available, appropriate treatment can control the disease. The advent of biologic drugs has led to the need for a clear definition of the disease severity and treatment response. A standardized list of outcomes that defines clinician-reported disease severity and patients' reported severity are therefore essential. Solid criteria to define the response to treatment and treatment failure are lacking to date.OBJECTIVE: This systematic review defines treatment goals in terms of clinician-reported disease severity and patient-reported outcomes, referring to the published moderate-to-severe AD clinical trials. The application of these goals in daily clinical practice will ensure a better selection of available treatment options, thus increasing patient quality of care.MATERIALS AND METHODS: A systematic literature search was performed to identify the treatments goals of randomized controlled clinical trials (RCTs) on moderate-to-severe adult AD published between January 2000 and October 2020.RESULTS: In total, 14 studies met the eligibility criteria. The most widely used tools in terms of clinician-reported disease severity were the Scoring of Atopic Dermatitis (SCORAD) followed by the Eczema Area Severity Score (EASI) and Investigator Global Assessment (IGA). For disease severity scales as efficacy outcome in RCTs, the greatest standardization and reproducibility was for improvement of at least 50% in EASI score and IGA score reduction of ≥2 grades from baseline. The most widely used tools from the patients' perspective were the Dermatology Life Quality Index (DLQI), Numeric Rate Scale (NRS)-itch and Patient Oriented Eczema Measure Score (POEM). In terms of patients' reported efficacy outcomes in RCTs, a numerical DLQI, NRS-itch and POEM score improvement of at least 4 points from baseline was reported.CONCLUSIONS: This systematic review highlights the need for collaboration between experts in order to define and optimize treatment outcomes. Despite considerable progress in harmonizing outcome measures, promoted by the foundation of the Harmonizing Outcome Measures for Eczema (HOME) initiative in 2008, our results demonstrate that this endpoint is still an unmet need. Based on the literature data we propose a minimum treatment goal algorithm for use in daily clinical practice aimed at stimulating a discussion on how the care of AD patients could be further improved

Blue light emission in the management of hard to heal wounds: a case series

Backgroun: Blue light (400 and 450 nm) contributes to bringing the inflammatory phase under control, increases angiogenesis, stimulates the metabolism of all cellular processes, reduces scar formation, increases collagen production, and decreases the bacterial burden. Methods: The aim of this study was to promote the healing process in 20 hard-to-heal wounds using a portable light-emitting diodes device that emits blue light (Emoled™). The primary endpoint of the study was to calculate in the three etiologic groups the reduction in wound size by the average delta area in square centimeters and as a percentage, and by the average healing rate (mm/Days). The secondary endpoint was to assess the wound bed score and to assess patients' pain (numerical rating scale). Results: At week 4 the average healing rate was 0.098 mm/days for venous leg ulcers, 0.353 mm/days for traumatic ulcers, and 0.09 mm/days for vasculitis. Overall 16 patients had a reduction in wound size, two patients were completely healed, and there was no improvement in two patients. At week 4, the average wound bed score had increased to 12.8 and average pain had decreased to 2.35. Almost all patients (n=19) showed pain reduction, and all the patients increased wound bed score. Conclusions: The blue LED device is promising in terms of promoting wound healing, improving WBS and reducing pain in patients affected by long-term wounds that do not respond to standard treatment

HS-TIME: A Modified TIME Concept in Hidradenitis Suppurativa Topical Management

Hidradenitis suppurativa (HS) is a chronic inflammatory disorder characterized by lesions such as abscesses and fistulas. The disease may require medical and/or surgical treatment, and the role of wound care is crucial. The acronym TIME (tissue nonviable, inflammation/infection, moisture imbalance, edge of wound) is widely recognized as a standardized approach to wound bed preparation

Wound Management Strategy for Treatment of Localized Cutaneous Leishmaniasis Using the TIME Framework

The current drugs available for the treatment of cutaneous leishmaniasis (CL) often cause several adverse events, and the risk-benefit ratio is low due to the risk of severe complications. Current treatment recommendations are based on data from areas endemic for leishmaniasis and are not always perfectly applicable, especially in cases of imported CL. Thus, it is crucial to assess the level of severity in each case to provide the most appropriate treatment modality. The World Health Organization recommends simple wound care (with unspecified strategies) or local therapy as first-line treatment. Systemic treatments should be reserved for selected patients. Additionally, there is little evidence in the literature regarding local treatments, such as paromomycin ointments, imiquimod, local infiltration with antimonials, and physical treatments such as cryotherapy or thermotherapy