Antimicrobial Photodynamic Therapy in Infected Diabetic Foot Ulcers: A Multicenter Preliminary Experience

Monami, Matteo; Scatena, Alessia; Schlecht, Michael; Lobmann, Ralf; Landi, Letizia; Ricci, Lucia; Mannucci, Edoardo

doi:10.7547/18-069

Cited by 13 publications

(17 citation statements)

References 21 publications

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“…The author had the same conclusion from the study as ours, namely that photodynamic therapy seems to represent a good alternative therapeutic choice for refractory chronic venous ulcers [ 21 ]. Monami et al performed A-PDT in patients with clinically infected ulcers who had been treated with RLP068 and demonstrated that the photosensitizer RLP068 under illumination seems to be a promising topical wound management procedure for the treatment of infected diabetic foot ulcers [ 22 ]. What process may underlie tissue healing after PDT?…”

Section: Discussionmentioning

confidence: 99%

Photodynamic Therapy for the Treatment of Infected Leg Ulcers—A Pilot Study

et al. 2021

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Chronic and infected leg ulcers (LUs) are painful, debilitating, resistant to antibiotics, and immensely reduce a patient’s quality of life. The purpose of our study was to demonstrate the efficacy of photodynamic therapy (PDT) for the treatment of infected chronic LUs. Patients were randomized into two experimental groups: the first group received 5-aminolevulinic acid photodynamic therapy (ALA-PDT) (10 patients), and the second group of 10 patients received local octenidine dihydrochloride (Octenilin gel) exposed to a placebo light source with an inserted filter that mimiced red light. In the PDT group, we used 20% ALA topically applied for 4 hrs and irradiation from a Diomed laser source with a wavelength of 630 nm at a fluency of 80 J/cm2. ALA-PDT was performed 10 times during a 14-day hospitalization in 10 patients of both sexes aged 40–85 years with chronic leg ulcers. Treatments were carried out at 3-week intervals for 3–5 cycles. At 8-month follow-up with the PDT group, complete remission (CR) was obtained in four patients (40%), partial response (>50% reduction in ulcer diameter) in four patients (40%), and no response in two patients (20%) who additionally developed deterioration of the local condition with swelling, erythema, and inflammation. To assess the degree of pain during the trials, we used a numeric rating scale (NRS). From the preliminary results obtained, we concluded that PDT can be used to treat leg ulcers as a minimally invasive and effective method with no serious side effects, although further studies on a larger group of patients with LUs are warranted.

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Section: Discussionmentioning

confidence: 99%

Photodynamic Therapy for the Treatment of Infected Leg Ulcers—A Pilot Study

et al. 2021

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“…Given the effectiveness and safety profile of the PDT-RLP068 system, along with preliminary data arising from clinical studies, 20 the addition of the PDT-RLP068 system to SoC was assumed to provide a benefit in terms of reduction of the time needed to reach a meaningful clinical target suggestive of the activation of the healing process (i.e., 40% reduction of the ulcers’ area). Accordingly, the effectiveness was measured in term of “additional days with clinical target achieved”.…”

Section: Methodsmentioning

confidence: 99%

“… 16 PDT could strongly contribute to wound healing of infected lesions through: immediate reduction of the local bacterial load; 17 effectiveness against all known classes of microorganisms; including wild type and resistant strains (also as biofilm status); 18 , 19 no induction of resistance as shown in vitro by multiple antimicrobial PDT treatments; 18 excellent safety and tolerability profile, thus safe for host tissues. 20 …”

Section: Introductionmentioning

confidence: 99%

“…Several observational studies in patients with DFU showed immediate significant reduction versus placebo of the total bacterial load after the initial administration 17 , 18 and significant improvement of the ulcer healing process after repeated applications. 20 Moreover, an observational study involving 36 patients with infected vascular, hard-to-heal leg ulcers treated twice over a four-day period before skin grafting surgery, has been completed. 21 …”

Section: Introductionmentioning

confidence: 99%

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New Perspective to Improve Care of Patients with Infected Diabetic Foot Ulcer: Early Economic Impact of the Use of Photodynamic Therapy with RLP068 (Based) System

Lorenzoni¹,

Chiavetta²,

Curci³

et al. 2021

CEOR

Self Cite

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Objective To perform an early economic evaluation of a system based on photodynamic advanced adjuvant therapy with photosensitizer RLP068/CI to facilitate the healing process of foot/leg skin lesions/ulcers with an excellent safety profile. Design An early short-term (10 weeks) cost-effectiveness and a budget impact analysis (over 5 years) comparing photodynamic therapy with photosensitizer RLP068/CI based (PDT-RLP068) system added to Standard of Care (SoC) vs SoC alone. Setting The Italian National Healthcare System perspective considering both the outpatient and the day-hospital regimen. Participants Hypothetical patients with diabetic foot infection (DFI) grades I/IIB. Interventions The PDT-RLP068 system as an add-on to Standard of Care (SoC) vs SoC alone as the first-line treatment for the management of DFIs. Main Outcomes Days within which the clinical target was achieved and direct health costs for patients’ management. Results Additional costs generated by the use of the PDT-RLP068 system progressively decreased as time to reach the target induced by the novel system decreased. In the outpatient regimen, when time to reach clinical target decreased in the range 7–28 days, ICERs varied from about 1€ to 70€ for each additional day gained with clinical target achieved. The system was dominant when halving time to reach the target in the outpatient regimen and even for modest reduction of time in day-hospital regimen. In terms of budget impact, when considering day-hospital regimen, if the PDT-RLP068 based system allowed a shortened duration to reach the clinical target of between 7–28 days, BI was 8,100,000€ to 700,000€, with saving less than 2,000,000€ with 50% reduction of time. Considering the inpatient setting, the use of the PDT-RLP068 system would result in saving even with the modest impact on the time needed to activate the healing process. Conclusion The early economic evaluation performed suggested that, if the claimed effectiveness of the technology demonstrated in case reports and in preliminary clinical studies can be confirmed in larger population studies, and allowing for shortening of the time needed to activate the healing process, the PDT-RLP068 system could offer the chance to improve care for DFI patients without compromising the sustainability of the system.

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“…Therefore bacteria are not able to develop resistance even after multiple uses of PDT [ 18 ]. Recently, there have been many promising studies on the efficacy of phthalocyanines in photodynamic antimicrobial chemotherapy (PACT) [ 19 , 20 , 21 , 22 , 23 , 24 ]. In 2020, Monami et al published promising results of a clinical trial in which patients with diabetic foot ulcers underwent photodynamic therapy using a phthalocyanine derivative ( I , RLP068, Figure 1 ) as a PS [ 19 ].…”

Section: Introductionmentioning

confidence: 99%

New Metallophthalocyanines Bearing 2-Methylimidazole Moieties—Potential Photosensitizers against Staphylococcus aureus

Wierzchowski

Ziental

Łażewski

et al. 2022

IJMS

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Newly developed tetra- and octasubstituted methimazole-phthalocyanine conjugates as potential photosensitizers have been obtained. Synthesized intermediates and final products were characterized by the MALD-TOF technique and various NMR techniques, including 2D methods. Single-crystal X-ray diffraction was used to determine the crystal structures of dinitriles. The studied phthalocyanines revealed two typical absorption bands—the Soret band and the Q band. The most intense fluorescence was observed for octasubstituted magnesium(II) phthalocyanine in DMF (ΦFL = 0.022). The best singlet oxygen generators were octasubstituted magnesium(II) and zinc(II) phthalocyanines (Φ∆ 0.56 and 0.81, respectively). The studied compounds presented quantum yields of photodegradation at the level between 10−5 and 10−6. Due to their low solubility in a water environment, the liposomal formulations were prepared. Within the studied group, octasubstituted zinc(II) phthalocyanine at the concentration of 100 µM activated with red light showed the highest antibacterial activity against S. aureus equal to a 5.68 log reduction of bacterial growth.

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Antimicrobial Photodynamic Therapy in Infected Diabetic Foot Ulcers: A Multicenter Preliminary Experience

Cited by 13 publications

References 21 publications

Photodynamic Therapy for the Treatment of Infected Leg Ulcers—A Pilot Study

Photodynamic Therapy for the Treatment of Infected Leg Ulcers—A Pilot Study

New Perspective to Improve Care of Patients with Infected Diabetic Foot Ulcer: Early Economic Impact of the Use of Photodynamic Therapy with RLP068 (Based) System

New Metallophthalocyanines Bearing 2-Methylimidazole Moieties—Potential Photosensitizers against Staphylococcus aureus

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