Clinical trial • Phase III • Infectious Disease|Endocrinology

GENTAMICIN for Diabetic foot osteomyelitis

Phase III trial of GENTAMICIN for Diabetic foot osteomyelitis.

Overview

Trial Therapeutic Area: Infectious Disease|Endocrinology
Trial Disease: Diabetic foot osteomyelitis
Trial Stage: Phase III
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 16-02-2026
First CTIS Authorization Date: 10-04-2026

Trial design

Randomised, levofloxacin orion 500 mg film-coated tablets (500 mg; route: oral; schedule: not specified); amoxicillin mip pharma 1000 mg tablets (1000 mg; route: oral; schedule: not specified); ciprofloxacin orion 500 mg film-coated tablets (500 mg; route: oral; schedule: not specified); kefexin 750 mg film-coated tablet (750 mg; route: oral; schedule: not specified); piperacillin/tazobactam 4 g/0.5 g for infusion (route: intravenous; dose details provided as product labels; schedule: not specified); doximed 100 mg tablet (doxycycline 100 mg; route: oral; schedule: not specified); ceftriaxon 2 g for infusion (2 g; route: intravenous; schedule: not specified); cotrim forte tablets (sulfamethoxazole/trimethoprim; route: oral; schedule: not specified); vancomycin mip pharma 1000 mg for infusion (1 g; route: intravenous; schedule: not specified); meropenem 1 g for injection/infusion (1 g; route: intravenous; schedule: not specified); metronidazole (iv or oral formulations listed; dose formulations per product labels; schedule: not specified); clindamycin 300 mg capsule (300 mg; route: oral; schedule: not specified); amoxin comp 500 mg/125 mg tablet (amoxicillin/clavulanate; route: oral; schedule: not specified); flucloxacillin 1 g tablet (1 g; route: oral; schedule: not specified); cefuroxim 1500 mg for injection/infusion (1.5 g; route: intravenous; schedule: not specified).-controlled Phase III trial across 2 sites in Finland.

Randomised: Yes
Comparator: Levofloxacin Orion 500 mg film-coated tablets (500 mg; route: oral; schedule: Not specified); Amoxicillin MIP Pharma 1000 mg tablets (1000 mg; route: oral; schedule: Not specified); Ciprofloxacin Orion 500 mg film-coated tablets (500 mg; route: oral; schedule: Not specified); Kefexin 750 mg film-coated tablet (750 mg; route: oral; schedule: Not specified); Piperacillin/Tazobactam 4 g/0.5 g for infusion (route: intravenous; dose details provided as product labels; schedule: Not specified); Doximed 100 mg tablet (doxycycline 100 mg; route: oral; schedule: Not specified); Ceftriaxon 2 g for infusion (2 g; route: intravenous; schedule: Not specified); Cotrim forte tablets (sulfamethoxazole/trimethoprim; route: oral; schedule: Not specified); Vancomycin MIP Pharma 1000 mg for infusion (1 g; route: intravenous; schedule: Not specified); Meropenem 1 g for injection/infusion (1 g; route: intravenous; schedule: Not specified); Metronidazole (IV or oral formulations listed; dose formulations per product labels; schedule: Not specified); Clindamycin 300 mg capsule (300 mg; route: oral; schedule: Not specified); Amoxin comp 500 mg/125 mg tablet (amoxicillin/clavulanate; route: oral; schedule: Not specified); Flucloxacillin 1 g tablet (1 g; route: oral; schedule: Not specified); Cefuroxim 1500 mg for injection/infusion (1.5 g; route: intravenous; schedule: Not specified).
Target Sample Size: 84
Trial Duration For Participant: 168

Eligibility

Recruits 84 Vulnerable population not selected. Written informed consent is required prior to any study procedures; participants must be 18 years or older. Inability to provide valid written informed consent is an exclusion criterion. No assent/parental consent provisions are provided (adults only)..

Pregnancy Exclusion: Pregnancy or breastfeeding or intending to become pregnant during the study
Vulnerable Population: Vulnerable population not selected. Written informed consent is required prior to any study procedures; participants must be 18 years or older. Inability to provide valid written informed consent is an exclusion criterion. No assent/parental consent provisions are provided (adults only).

Inclusion criteria

{"criterion_text":"- Written informed consent obtained prior to any study procedures\n- Aged 18 years or older at screening\n- Clinical and radiological diagnosis of acute or chronic osteomyelitis associated with diabetic foot ulcer or infection\n- Able to comply with study procedures and attend scheduled visits\n- For women of childbearing potential, willing to use effective contraception for the duration of the study and for at least three months afterward, following local guidelines and CTFG recommendations.\n- Adequate renal function as determined by creatinine clearance ≥60 mL/min"}

Exclusion criteria

{"criterion_text":"- Known allergy or hypersensitivity to any study medication or ingredients (vancomycin, gentamicin, calcium sulfate).\n- Pregnancy or breastfeeding or intending to become pregnant during the study\n- Participation in another clinical trial involving an investigational product within 30 days prior to enrollment\n- Inability to provide valid written informed consent\n- Any severe concomitant disease or condition which, in investigator opinion, would pose an unacceptable risk or interfere with valid study results.\n- History of substance abuse or psychiatric conditions interfering with protocol adherence."}

Endpoints

Primary endpoints

{"endpoint_text":"- \tHealed ulcer/osteomyelitis resolution at 12 and 24 weeks (no further antimicrobial treatment, stable wound closure)","definition_or_measurement_approach":"Outcome measured at 12 and 24 weeks; defined as healed ulcer/osteomyelitis resolution indicated by no further antimicrobial treatment and stable wound closure."}

Recruitment

Planned Sample Size: 84
Recruitment Window Months: 54
Consent Approach: Written informed consent obtained prior to any study procedures. Participants must be aged 18 years or older and provide their own consent. Inability to provide valid written informed consent is an exclusion criterion. Languages of consent documents not specified in the record.

Geography

Total Number Of Sites: 2
Total Number Of Participants: 84

Finland

Earliest CTIS Part Ii Submission Date: 24-03-2026
Latest Decision Or Authorization Date: 10-04-2026
Processing Time Days: 17
Number Of Sites: 2
Number Of Participants: 84

Sites

Site Name: Pirkanmaan hyvinvointialue
Department Name: Department of Musculoskeletal Surgery
Principal Investigator Name: Ilkka Kaartinen
Principal Investigator Email: ilkka.kaartinen@pirha.fi
Contact Person Name: Ilkka Kaartinen
Contact Person Email: ilkka.kaartinen@pirha.fi

Site Name: HUS-yhtymae
Department Name: Department of Plastic and Reconstructive Surgery
Principal Investigator Name: Toni Seppälä
Principal Investigator Email: toni.p.seppala@helsinki.fi
Contact Person Name: Toni Seppälä
Contact Person Email: toni.p.seppala@helsinki.fi

Sponsor

Primary sponsor

Full Name: Pirkanmaan hyvinvointialue
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: Finland

Investigational products

Investigational Product Name: Gensumycin 40 mg/ml injektioneste, liuos
Active Substance: GENTAMICIN
Modality: Small molecule
Routes Of Administration: LOCAL USE
Route: LOCAL USE
Authorisation Status: Authorised
Maximum Dose: 240 mg (max daily amount reported)

Investigational Product Name: Vancomycin MIP Pharma 500 mg, Infuusiokuiva-aine, liuosta varten
Active Substance: VANCOMYCIN HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: LOCAL USE
Route: LOCAL USE
Authorisation Status: Authorised
Maximum Dose: 1 g (max daily amount reported)

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