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Randomized Controlled Trial
. 2025 May 9;6(5):100565.
doi: 10.1016/j.medj.2024.11.018. Epub 2024 Dec 30.

Randomized double-blind study on safety and tolerability of TP-102 phage cocktail in patients with infected and non-infected diabetic foot ulcers

Ran Nir-Paz  1 , Hadil Onallah  1 , Michal Dekel  2 , Yechiel N Gellman  1 , Amir Haze  1 , Ronen Ben-Ami  2 , Ron Braunstein  3 , Ronen Hazan  3 , Danna Dror  1 , Yonatan Oster  1 , Meir Cherniak  1 , Fabienne Attal  1 , Ana Raquel Barbosa  4 , Helena Dordio  4 , Alexandra Wagner  4 , Daniela Jones-Dias  4 , José Neves  5 , Margarida Barreto  4 , Clara Leandro  6 , Sofia Côrte-Real  4 , Miguel Garcia  4
Affiliations
Randomized Controlled Trial

Randomized double-blind study on safety and tolerability of TP-102 phage cocktail in patients with infected and non-infected diabetic foot ulcers

Ran Nir-Paz et al. Med. .

Abstract

Background: Phage therapy offers a promising alternative for treating serious infections, including diabetic foot ulcers (DFUs), through the lytic action of phages. This randomized double-blind study was conducted to evaluate the safety and tolerability of the TP-102 bacteriophage cocktail in patients with DFUs non-infected and infected with Staphylococcus aureus, Pseudomonas aeruginosa, and/or Acinetobacter baumannii.

Methods: Nineteen participants with DFUs were randomized after susceptibility testing. TP-102 was applied topically at 10⁹ plaque-forming units (PFUs)/mL/cm³ to the target ulcer: 1 week for non-infected DFUs and 28 days for infected DFUs (PEDIS grade 2/3). The study was conducted in Israel.

Findings: Main outcomes included the incidence and severity of TP-102-related adverse events, microbiological data, and ulcer healing. Thirteen patients received TP-102. No treatment-related adverse events were reported. Although the study was underpowered to determine the superiority of TP-102 over placebo, a greater proportion of patients in the TP-102 + standard of care (SOC) group showed microbiological reduction of target bacteria (t = 26) compared to the placebo + SOC group (80% versus 50%, p = 1.000). Additionally, a higher proportion of TP-102 patients reached 50% and 75% wound closure compared to placebo (5/7 [71.4%] versus 1/3 [33.3%], p = 0.500 and 2/7 [28.6%] versus none, p = 1.000, respectively). One patient in the TP-102 group achieved wound closure.

Conclusions: TP-102 was well tolerated and safe, showing potential as a groundbreaking treatment in this field. Further studies are needed to confirm its safety and efficacy in larger populations with diabetic foot infections (ClinicalTrials.gov: NCT04803708).

Funding: None to declare.

Keywords: Translation to patients; bacteriophage; clinical trial; diabetes; diabetic foot ulcers; infection; phage.

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Conflict of interest statement

Declaration of interests R.N.-P. has been a scientific consultant for BiomX and has participated in and served as a PI and on data safety monitoring boards for a clinical trial by Technophage. R.B.-A. has actively contributed to clinical boards with GlaxoSmithKline and Merck Sharp and has also been involved in lecturing events associated with Teva and Gilead Sciences. S.C.-R. and C.L. participated in a clinical trial by Technophage as cohort escalation committee and safety review committee members, respectively; they are inventors in Technophage’s patents. M.G. is a board member of Technophage S.A., Vector B2B, and LxBio Pharmaceuticals S.A.

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