NCT05177107: DANCE

Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis

Terminated Phase 2 Last updated 19 August 2025

What this trial tests

Phase 2 trial testing Bacteriophage Therapy in Osteomyelitis in 41 participants. Terminated before completion.

Timeline

24 November 2021

Primary endpoint
30 January 2025

30 May 2025

Quick facts

Lead sponsor	Adaptive Phage Therapeutics, Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	41
Start date	24 November 2021
Primary completion	30 January 2025
Estimated completion	30 May 2025
Sites	15 locations across United States

Drugs / interventions tested

• Bacteriophage Therapy — full drug profile →
• Placebo

Conditions studied

• Osteomyelitis — all drugs for Osteomyelitis →
• Diabetic Foot Osteomyelitis — all drugs for Diabetic Foot Osteomyelitis →

Sponsor

Adaptive Phage Therapeutics, Inc.

Who can join

Adults 18 to 85, any sex, with Osteomyelitis or Diabetic Foot Osteomyelitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase 2b randomized trial designed to evaluate bacteriophage therapy in subjects with diabetic foot osteomyelitis.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Regulations of phage therapy across the world.
   Yang Q, Le S, Zhu T, Wu N. · · 2023 · cited 86× · PMID 37869667 · DOI 10.3389/fmicb.2023.1250848
2. Current status of bacteriophage therapy for severe bacterial infections.
   Sawa T, Moriyama K, Kinoshita M. · · 2024 · cited 49× · PMID 39482746 · DOI 10.1186/s40560-024-00759-7
3. Current Status of Phage Therapy against Infectious Diseases and Potential Application beyond Infectious Diseases.
   Xu HM, Xu WM, Zhang L. · · 2022 · cited 15× · PMID 36263241 · DOI 10.1155/2022/4913146
4. Short and oral antimicrobial therapy for diabetic foot infection: a narrative review of current knowledge.
   Maurer SM, Hepp ZS, McCallin S, Waibel FWA, et al · · 2022 · cited 13× · PMID 35415069 · DOI 10.5194/jbji-7-61-2022
5. Phage therapy: a promising approach for <i>Staphylococcus aureus</i> diabetic foot infections.
   Plumet L, Magnan C, Costechareyre D, Sotto A, et al · · 2025 · cited 6× · PMID 40366171 · DOI 10.1128/jvi.00458-25
6. Phage and Endolysin Therapy Against Antibiotics Resistant Bacteria: From Bench to Bedside.
   Taati Moghadam M, Mohebi S, Sheikhi R, Hasannejad-Bibalan M, et al · · 2025 · cited 4× · PMID 40661138 · DOI 10.1002/mco2.70280
7. The landscape of biofilm models for phage therapy: mimicking biofilms in diabetic foot ulcers using 3D models.
   Martinet MG, Thomas M, Bojunga J, Pletz MW, et al · · 2025 · cited 3× · PMID 40066272 · DOI 10.3389/fmicb.2025.1553979
8. Bacteriophage Therapy: Current Strategies and Future Perspectives.
   Zhou Z, Fu H, Li M, Han Z, et al · · 2026 · PMID 41777249 · DOI 10.1002/mco2.70645