LIBRETTO: Stimulan™ Local Antibiotic Delivery System Versus 4-Week Systemic Antibiotic Therapy for Diabetic Foot Osteomyelitis – A Prospective, Randomized, Controlled Trial

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524723-52-00

Enrollment

Registered

2026-04-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Osteomyelitis

Brief summary

• Healed ulcer/osteomyelitis resolution at 12 and 24 weeks (no further antimicrobial treatment, stable wound closure)

Interventions

DRUGCefuroxim MIP Pharma 1500 mg injektio/infuusiokuiva-aine

DRUGliuosta varten

DRUGVancomycin MIP Pharma 500 mg

DRUGInfuusiokuiva-aine

DRUGAmoxicillin MIP Pharma 1000 mg tabletit

DRUGMetronidazole Braun 5 mg/ml infuusioneste

DRUGliuos

DRUGVancomycin MIP Pharma 1000 mg

DRUGDoximed 100 mg tabletti

DRUGCeftriaxon Fresenius Kabi 2 g infuusiokuiva-aine

DRUGLevofloxacin Orion 500 mg kalvopäällysteiset tabletit

DRUGCiprofloxacin Orion 500 mg kalvopäällysteiset tabletit

DRUGClindamycin Orion 300 mg kapseli

DRUGkova

DRUGPiperacillin/Tazobactam Fresenius Kabi 4 g/0

DRUG5 g infuusiokuiva-aine

DRUGMeropenem AptaPharma 1 g injektio-/infuusiokuiva-aine

DRUGFlucloxacillin Orion 1 g kalvopäällysteiset tabletit

DRUGKefexin 750 mg tabletti

DRUGkalvopäällysteinen

DRUGAmoxin comp 500 mg / 125 mg tabletti

DRUGTrikozol 400 mg tabletit

DRUGGensumycin 40 mg/ml injektioneste

DRUGCotrim forte tabletit

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• Healed ulcer/osteomyelitis resolution at 12 and 24 weeks (no further antimicrobial treatment, stable wound closure)	—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 11, 2026