Photodynamic therapy for infected diabetic foot ulcers

NewsBot · Oct 18, 2012

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Phase IIa randomised, placebo-controlled study of antimicrobial photodynamic therapy in bacterially colonised, chronic leg ulcers and diabetic foot ulcers. A new approach to antimicrobial therapy.
Morley S, Griffiths J, Philips G, Moseley H, O'Grady C, Mellish K, Lankester CL, Faris B, Young RJ, Brown SB, Rhodes LE.
Br J Dermatol. 2012 Oct 15

Background: With increasing problems of antibiotic-resistance, photodynamic therapy (PDT) is being developed as a novel anti-microbial treatment. Following light activation, cationic photosensitiser 3,7-Bis(di-n-butylamino) phenothiazin-5-ium bromide (PPA904) kills a broad spectrum of bacteria in vitro and this has a variety of potential clinical applications.

Objectives: To determine if PDT in bacterially colonised chronic leg ulcers and chronic diabetic foot ulcers can reduce bacterial load, and potentially lead to accelerated wound healing.

Methods: 16 patients with chronic leg ulcers and 16 patients with diabetic foot ulcers (each 8 active treatment/8 placebo) were recruited into a blinded, randomised, placebo-controlled, single treatment, Phase IIa trial. All patients had ulcer duration >3 months, bacterially colonised with >10(4) cfu/ml. After quantitatively assessing pre-treatment bacterial load via swabbing, PPA904 or placebo was applied topically to wounds for 15 minutes, followed immediately by 50 J/cm(2) of red light and the wound again sampled for quantitative microbiology. Wound area was measured for up to 3 months following treatment.

Results: Treatment was well tolerated with no reports of pain or other safety issues. In contrast to placebo, patients on active treatment showed a reduction in bacterial load immediately post-treatment (p<0.001). After 3 months, 50% (4 of 8) of actively treated chronic leg ulcer patients showed complete healing, compared to 12.5% (1 of 8) placebo patients.

Conclusions: This first controlled study of PDT in chronic wounds demonstrated significant reduction in bacterial load. An apparent trend towards wound healing was observed; further study of this aspect with larger patient numbers is indicated.
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NewsBot · Oct 26, 2012

Press Release:
Combined antimicrobial and light therapy effective for treating foot ulcers

Results from a phase II study show that antimicrobial photodynamic therapy (PDT) is significantly more effective than placebo for treating patients with chronic leg ulcers.

Writing in the British Journal of Dermatology, Lesley Rhodes (University of Manchester, UK) and colleagues report that after 3 months, 50.0% of ulcers treated with PDT had healed completely compared with only 12.5% of those in the placebo group.

The patients in the study all had ulcers for over 3 months (16 chronic leg ulcers; 16 diabetic foot ulcers). They were randomly assigned in a blinded fashion to treatment with placebo or PDT (eight chronic leg ulcers and eight diabetic foot ulcers in each group).

The patients had the antimicrobial PPA904 or a placebo lotion applied to their wounds before both groups were exposed to 50 J/cm2 of red light. The wounds were swabbed before and after treatment to assess bacterial counts and the antibacterial efficacy of the treatments, and the patients were followed up at 3 months for assessment of wound healing.

There was a significant reduction in the bacterial load of all wounds treated with PDT immediately after treatment (approximately 1 log in magnitude), whereas there was no change in those treated with placebo.

In addition, wound healing was significantly better with antimicrobial and PDT than placebo, although the analysis was restricted to those with chronic leg ulcers, "as there were insufficient data points for the longer times following treatment," for patients with diabetic foot ulcers, say the researchers.

No major adverse events linked to the treatment were observed, notes the team.

"Bacterial colonization of chronic wounds can both delay healing and lead to life threatening clinical infections," write the authors.

They say that the PDT method "appears to be safe and convenient and should be adaptable for use in non-hospital settings, such as local practitioner surgeries or in patient's homes."

However, "further investigation is indicated in larger patient numbers, using optimized drug formulation and light source, and repeat treatments, to attempt to achieve greater, sustained bacterial cell kill and to assess wound healing," they add.
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NewsBot · Sep 8, 2019

The benefits of antimicrobial photodynamic therapy with RLP068 in
the management of diabetic foot ulcers.
Martinelli N, Curci V, Quarantiello A, Saldalamacchia G
Drugs in Context 2019;8:

This article is the first part of a literature review concerning
diabetic foot ulcers and the use of antimicrobial photodynamic
therapy (PDT). Diabetic foot ulcers are associated with high
morbidity, mortality, and healthcare costs. Natural healing is
often delayed by microbial infection or colonisation, which
might lead to serious complications, such as amputation.
Furthermore, antibiotic treatment could have limited success
because of the development of bacterial resistance and severely
limited drug delivery to the ulcer due to vascular damage.
PDT has antimicrobial effects and has been used to reduce the
total and pathogenic microbial load in diabetic ulcers without
inducing bacterial resistance. It is safe and can be used to
improve outcomes. A clinical trial demonstrated that PDT with
RLP068 reduced the microbial load of diabetic ulcers in 62
patients. This article reports previously published evidence and
presents four, unpublished, clinical cases treated in the real-life
setting.
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NewsBot · Sep 15, 2019

The benefits of antimicrobial photodynamic therapy with RLP068 in the management of diabetic foot ulcers.
Martinelli N et al
Drugs Context. 2019 Aug 20

This article is the first part of a literature review concerning diabetic foot ulcers and the use of antimicrobial photodynamic therapy (PDT). Diabetic foot ulcers are associated with high morbidity, mortality, and healthcare costs. Natural healing is often delayed by microbial infection or colonisation, which might lead to serious complications, such as amputation. Furthermore, antibiotic treatment could have limited success because of the development of bacterial resistance and severely limited drug delivery to the ulcer due to vascular damage. PDT has antimicrobial effects and has been used to reduce the total and pathogenic microbial load in diabetic ulcers without inducing bacterial resistance. It is safe and can be used to improve outcomes. A clinical trial demonstrated that PDT with RLP068 reduced the microbial load of diabetic ulcers in 62 patients. This article reports previously published evidence and presents four, unpublished, clinical cases treated in the real-life setting.
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NewsBot · Feb 20, 2020

Antimicrobial Photodynamic Therapy in Infected Diabetic Foot Ulcers: A Multicenter Preliminary Experience.
Matteo Monami, Alessia Scatena, Michael Schlecht, Ralf Lobmann, Letizia Landi, Lucia Ricci, and Edoardo Mannucci
Journal of the American Podiatric Medical Association: January 2020, Vol. 110, No. 1, Article_5.

Background: 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.

Methods: 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.

Results: 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.

Conclusions: RLP068 seems to be a promising topical wound management procedure for the treatment of infected diabetic foot ulcers.
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NewsBot · Jun 24, 2020

Photodynamic Topical Antimicrobial Therapy for Infected Diabetic Foot Ulcers in Patients With Diabetes: A Case Series
Enrico Brocco, MD, Vincenzo Curci, MD, Roberto Da Ros, MD, ...
The International Journal of Lower Extremity Wounds June 19, 2020

Diabetic foot ulcers (DFUs) are common, complex, costly complications, associated with frequent recurrences and increased morbidity and mortality. DFUs can be prevented and their healing can be mostly influenced by appropriately and aggressively managing any infection, but the role of antiseptic therapies in reducing healing time lacks sufficient evidence. Several therapeutic interventions have been developed based on the principles of photomedicine to overcome the issue of poor drug circulation in infected areas, with the aim of killing microbial agents while leaving the surrounding host cells unharmed. Such techniques use absorption of photons by specific chromophores. Among these, RLP068 is a tetracationic Zn(II) phthalocyanine derivative activated by exposure to red light, used as a topical treatment for superficial bacterial and fungal infections. The photoactivation of RLP068 results in the production of singlet oxygen and other reactive oxygen species, able to affect a range of cellular targets, including cell membrane and/or wall, cytoplasm, and cellular components, resulting in a rapid, broad range, bactericidal and fungicidal effect. The phase IIa study showed that photoactivated RPL068 is capable of inducing a dose-dependent reduction in total and pathogen microbial load in infected diabetic foot ulcers. In this article, a case series of 22 DFU treated with photoactivated RLP068 at 5 different centers in Italy is presented. Considering microbial agents reduction, ulcer healing facilitation, healing rate (9 DFUs out of 22), and amputation rate (only 1 case over 22), the decrease in the cost of DFU seems to be a point in favor of RLP068 and its cost-effectiveness.
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NewsBot · Mar 29, 2022

Efficacy and safety of ALA-PDT in treatment of diabetic foot ulcer with infection
Xinying Li et al
Photodiagnosis Photodyn Ther. 2022 Mar 21

Background: Diabetic foot ulcers (DFUs) with infection is a major clinical issue, as the infection not only potentially devastate the wound healing, but also is the factor that most often leads to amputation. Nevertheless, traditional antibiotic treatment is often insufficient to clear the infection, which could lead to side effects. Photodynamic therapy (PDT) has broad-spectral antibacterial activity. Meanwhile, it is difficult to induce antibiotic resistance. Here, we aim to evaluate the safety and efficacy of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) in the treatment of DFUs with infection.

Methods: In our study, 5 diabetic patients with infectious DFUs were diagnosed by pathological examination and the depth of wound was examined by X-Ray. All patients' wounds were firstly irradiated with 20% ALA-PDT (635 nm, 100 J/cm2, 80 mW/cm2) using the red LED to control the infection. Treatment will be combined with debridement if there is granulation necrosis or secretion on the wound surface. PDT sessions were performed weekly in all patients until healing was achieved. All patients were followed up for 0.6-1.2 years after treatment.

Results: In 5 patients, the DFUs with infection was completely controlled by ALA-PDT. There was no recurrence of DFUs in the follow-up of 0.9 years (range, 0.6-1.2 years) after the treatment.

Conclusions: ALA-PDT treatment for DFUs with infection show successful outcomes and ultimately avoid amputations.
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NewsBot · May 18, 2023

Photodynamic therapy for infected foot ulcers in people with diabetes mellitus: a systematic review
Maria Girlane Sousa Albuquerque Brandão et al
Sao Paulo Med J. 2023 May 12;141(6)

Background: Ulceration of the feet in patients with diabetes is a frequent complication that increases morbidity, mortality, hospitalization, treatment costs, and non-traumatic amputations.

Objective: To present a systematic review of the treatment of patients with diabetes mellitus and infected foot ulcers using photodynamic therapy.

Design and setting: A systematic review was performed in the postgraduate program in nursing at the Universidade da Integração Internacional da Lusofonia Afro-Brasileira, Ceará, Brazil.

Methods: PubMed, CINAHL, Web of Science, EMBASE, Cochrane Library, Scopus, and LILACS databases were screened. The methodological quality, risk of bias, and quality of evidence of each study were assessed. Review Manager was used for the meta-analysis.

Results: Four studies were included. They highlighted significantly better outcomes in patient groups treated with photodynamic therapy than those in the control groups that were treated with topical collagenase and chloramphenicol (P = 0.036), absorbent (P < 0.001), or dry covers (P = 0.002). Significant improvements were noted in terms of the microbial load in the ulcers and tissue repair, with a reported reduction in the need for amputation by up to 35 times. Photodynamic therapy resulted in significantly better outcomes between the experimental and control groups (P = 0.04).

Conclusion: Photodynamic therapy is significantly more effective in treating infected foot ulcers than standard therapies.
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NewsBot · Feb 20, 2024

Adjuvant effect of antimicrobial photodynamic therapy (aPDT) in the treatment of diabetic foot ulcers: A case series
Rita de Cassia Ferreira et al
J Biophotonics. 2024 Jan 22

This study aimed to evaluate the clinical evolution of patients with diabetic foot ulcer treated with antimicrobial photodynamic therapy (aPDT) using the Bates-Jensen (BJ) scale. A total of 21 patients were monitored, with an average age of 58 years. Patients underwent the standard treatment protocol of the institution, supplemented with aPDT utilizing 0.01% methylene blue (MB) and laser irradiation (660 nm, 100 mW, 6 J per point). Following aPDT, the lesions were protected with hydrofiber dressings containing silver. The Bates-Jensen Scale was employed at pre-treatment and post-aPDT sessions to assess lesion progression. The results demonstrated a significant difference between pre- and post-treatment values in the overall BJ score. The use of MB in aPDT proved to be an effective, safe, well-tolerated treatment with high patient adherence and the potential for implementation in the care of diabetic foot conditions.
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