Diabetic Foot… · Phase III (2025-524723-52-00)

Status Authorised, recruitment pending · 1 EU/EEA countries · 2 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Authorised, recruitment pending

Participants planned 84

Countries 1

Sites 2

Diabetic Foot Osteomyelitis

To compare the Stimulan Rapid Cure™ medical device used as local antibiotic treatment for diabetic foot osteomyelitis to a control group receiving systemic antibiotic therapy

Key facts

Sponsor: Pirkanmaan hyvinvointialue
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18], Diseases [C] - Bacterial Infections and Mycoses [C01]
Decision date (initial): 2026-04-10
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To compare the Stimulan Rapid Cure™ medical device used as local antibiotic treatment for diabetic foot osteomyelitis to a control group receiving systemic antibiotic therapy

Conditions and MedDRA coding

Diabetic Foot Osteomyelitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

Written informed consent obtained prior to any study procedures
Aged 18 years or older at screening
Clinical and radiological diagnosis of acute or chronic osteomyelitis associated with diabetic foot ulcer or infection
Able to comply with study procedures and attend scheduled visits
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.
Adequate renal function as determined by creatinine clearance ≥60 mL/min

Exclusion criteria 6

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Gensumycin 40 mg/ml injektioneste, liuos

PRD11564929 · Product

Active substance: Gentamicin
Substance synonyms: 2-[4,6-DIAMINO-3-[3-AMINO-6-(1-METHYLAMINOETHYL)OXAN-2-YL]OXY-2-HYDROXY-CYCLOHEXYL]OXY-5-METHYL-4-METHYLAMINO-OXANE-3,5-DIOL, 2-[4,6-DIAMINO-3-[3-AMINO-6-(1-METHYLAMINOETHYL)OXAN-2-YL]OXY-2-HYDROXYCYCLOHEXYL]OXY-5-METHYL-4-METHYLAMINOOXANE-3,5-DIOL
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: LOCAL USE
Max daily dose: 240 mg milligram(s)
Max total dose: 240 mg milligram(s)
Max treatment duration: 8 Week(s)
Authorisation status: Authorised
ATC code: J01GB03 — GENTAMICIN
Marketing authorisation: 8959
MA holder: AMDIPHARM LIMITED
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Vancomycin MIP Pharma 500 mg, Infuusiokuiva-aine, liuosta varten

PRD12772906 · Product

Active substance: Vancomycin Hydrochloride
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: LOCAL USE
Max daily dose: 1 g gram(s)
Max total dose: 1 g gram(s)
Max treatment duration: 8 Week(s)
Authorisation status: Authorised
ATC code: J01XA01 — VANCOMYCIN
Marketing authorisation: 28523
MA holder: MIP PHARMA GMBH
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Comparator 16

Ciprofloxacin Orion 500 mg kalvopäällysteiset tabletit

PRD11858540 · Product

Active substance: Ciprofloxacin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 500 mg milligram(s)
Max total dose: 14000 mg milligram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: J01MA02 — CIPROFLOXACIN
Marketing authorisation: 23576
MA holder: ORION CORPORATION
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Amoxicillin MIP Pharma 1000 mg tabletit

PRD2501754 · Product

Active substance: Amoxicillin
Substance synonyms: AMOXICILLINE, AMOXICILLINUM
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 3 g gram(s)
Max total dose: 84 g gram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: J01CA04 — AMOXICILLIN
Marketing authorisation: 28607
MA holder: MIP PHARMA GMBH
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Flucloxacillin Orion 1 g kalvopäällysteiset tabletit

PRD11857867 · Product

Active substance: Flucloxacillin
Substance synonyms: FLOXACILLIN, (2S,5R,6R)-6-[[3-(2-CHLORO-6-FLUORO-PHENYL)-5-METHYL-OXAZOLE-4-CARBONYL]AMINO]-3,3-DIMETHYL-7-OXO-4-THIA-1-AZABICYCLO[3.2.0]HEPTANE-2-CARBOXYLIC ACID
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 4500 mg milligram(s)
Max total dose: 126000 mg milligram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: J01CF05 — FLUCLOXACILLIN
Marketing authorisation: 33657
MA holder: ORION CORPORATION
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Amoxin comp 500 mg / 125 mg tabletti, kalvopäällysteinen

PRD11854010 · Product

Active substance: Amoxicillin Trihydrate
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 1500 mg milligram(s)
Max total dose: 42000 mg milligram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: J01CR02 — AMOXICILLIN AND ENZYME INHIBITOR
Marketing authorisation: 14871
MA holder: RATIOPHARM GMBH
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Levofloxacin Orion 500 mg kalvopäällysteiset tabletit

PRD3200071 · Product

Active substance: Levofloxacin
Substance synonyms: HR355
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 500 mg milligram(s)
Max total dose: 14000 mg milligram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: J01MA12 — LEVOFLOXACIN
Marketing authorisation: 32809
MA holder: ORION CORPORATION
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Kefexin 750 mg tabletti, kalvopäällysteinen

PRD545792 · Product

Active substance: Cefalexin Monohydrate
Substance synonyms: CEPHALEXIN MONOHYDRATE
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 2250 mg milligram(s)
Max total dose: 63000 mg milligram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: J01DB01 — -
Marketing authorisation: 12220
MA holder: ORION CORPORATION
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Piperacillin/Tazobactam Fresenius Kabi 4 g/0,5 g infuusiokuiva-aine, liuosta varten

PRD767185 · Product

Active substance: Piperacillin Sodium
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 12 g gram(s)
Max total dose: 336 g gram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
Marketing authorisation: 23777
MA holder: FRESENIUS KABI AB
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Meropenem AptaPharma 1 g injektio-/infuusiokuiva-aine, liuosta varten

PRD12044543 · Product

Active substance: Meropenem Trihydrate
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 3 g gram(s)
Max total dose: 84 g gram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: J01DH02 — MEROPENEM
Marketing authorisation: 43663
MA holder: APTA MEDICA INTERNACIONAL D.O.O.
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cefuroxim MIP Pharma 1500 mg injektio/infuusiokuiva-aine, liuosta varten

PRD12590348 · Product

Active substance: Cefuroxime
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 4.5 g gram(s)
Max total dose: 126 g gram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: J01DC02 — -
Marketing authorisation: 29920
MA holder: MIP PHARMA GMBH
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Clindamycin Orion 300 mg kapseli, kova

PRD11862986 · Product

Active substance: Clindamycin
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 1200 mg milligram(s)
Max total dose: 33600 mg milligram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: J01FF01 — CLINDAMYCIN
Marketing authorisation: 18923
MA holder: ORION CORPORATION
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cotrim forte tabletit

PRD604000 · Product

Active substance: Sulfamethoxazole
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 320 mg milligram(s)
Max total dose: 8960 mg milligram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: J01EE01 — SULFAMETHOXAZOLE AND TRIMETHOPRIM
Marketing authorisation: 10610
MA holder: RATIOPHARM GMBH
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Vancomycin MIP Pharma 1000 mg, Infuusiokuiva-aine, liuosta varten

PRD12772966 · Product

Active substance: Vancomycin Hydrochloride
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 2 g gram(s)
Max total dose: 56 g gram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: J01XA01 — VANCOMYCIN
Marketing authorisation: 28524
MA holder: MIP PHARMA GMBH
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metronidazole Braun 5 mg/ml infuusioneste, liuos

PRD11869190 · Product

Active substance: Metronidazole
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 1500 mg milligram(s)
Max total dose: 42000 mg milligram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: J01XD01 — METRONIDAZOLE
Marketing authorisation: 11984
MA holder: B.BRAUN MELSUNGEN AG
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Trikozol 400 mg tabletit

PRD11840123 · Product

Active substance: Metronidazole
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 1200 mg milligram(s)
Max total dose: 33600 mg milligram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: P01AB01 — METRONIDAZOLE
Marketing authorisation: 8556
MA holder: ORION CORPORATION
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ceftriaxon Fresenius Kabi 2 g infuusiokuiva-aine, liuosta varten

PRD669082 · Product

Active substance: Ceftriaxone Sodium
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 2 g gram(s)
Max total dose: 56 g gram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: J01DD04 — -
Marketing authorisation: 23454
MA holder: FRESENIUS KABI AB
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Doximed 100 mg tabletti

PRD12700817 · Product

Active substance: Doxycycline Monohydrate
Substance synonyms: DOXYCYCLINE HYDRATE
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 200 mg milligram(s)
Max total dose: 5600 mg milligram(s)
Max treatment duration: 4 Week(s)
Authorisation status: Authorised
ATC code: J01AA02 — DOXYCYCLINE
Marketing authorisation: 11061
MA holder: RATIOPHARM GMBH
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pirkanmaan hyvinvointialue

Sponsor organisation: Pirkanmaan hyvinvointialue
Address: Elamanaukio 2
City: Tampere
Postcode: 33520
Country: Finland

Scientific contact point

Organisation: Pirkanmaan hyvinvointialue
Contact name: Ilkka Kaartinen

Public contact point

Organisation: Pirkanmaan hyvinvointialue
Contact name: Ilkka Kaartinen

Locations

1 EU/EEA country · 2 investigational sites

By country

Country	MS status	Planned subjects	Sites
Finland	Authorised, recruitment pending	84	2
Rest of world	—	0	—

Investigational sites

Finland

2 sites · Authorised, recruitment pending

Pirkanmaan hyvinvointialue

Department of Musculoskeletal Surgery, Elamanaukio 2, 33520, Tampere

HUS-yhtymae

Department of Plastic and Reconstructive Surgery, Stenbackinkatu 11, 00290, Helsinki

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Protocol_EU-CT 2025-524723-52-00_Redacted	2
Recruitment arrangements (for publication)	K1_Recruitment arrangements	2
Subject information and informed consent form (for publication)	L1_SIS and ICF_Study participant_redacted	2
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Amoxicillin	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Amoxin comp	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Ciprofloxacin	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Clindamycin per os	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Doksisykliini	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Flukloksasilliini	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Gentamysiini	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Kefexin	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Keftriaksoni	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Kefuroksiimi	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Levofloxacin	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Meropenem	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Metronidatsoli	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Metronidatsoli per os	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Piperasilliini-Tazobaktaami	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Sulfa-trimetopriimi	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Vankomysiini	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Vankomysiini	1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2026-02-16	Finland	Acceptable 2026-04-07	2026-04-10

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

Overview

Key facts

Trial design

Main objective

Conditions and MedDRA coding

Eligibility criteria

Inclusion criteria 6

Exclusion criteria 6

Endpoints

Primary endpoints 1

Investigational products

Test 2

Comparator 16

Sponsors and contacts

Pirkanmaan hyvinvointialue

Scientific contact point

Public contact point

Locations

By country

Investigational sites

Results and documents

Documents 21 files

Application history

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