Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT02652169
Eligibility Criteria:
Inclusion Criteria:
* Males and females aged over 18 who are able to give informed consent
* Chronic venous ulcer with localized non-systemic soft-tissue infection diagnosed by senior infectious diseases specialist based on US FDA Guidance for Industry Chronic cutaneous ulcer and burn wounds June 2006:
* slough and necrotic tissue
* exsudate
* smell
* inflammation
* presence of granulation tissue
* pain
* Wound size ≥ 5 cm2 and \< 200 cm2
Exclusion Criteria:
* Non-treated diabetes mellitus, HbA1c \> 12 mg/dl
* Non treated (orthopaedic shoe) diabetic foot syndrome
* ABI \< 0,7
* Wound size 15 cm2 and \> 200 cm2
* CRP \> 5 mg/dl
* Leucocytes \> 15.000 /μl
* Infection of another site
* Infection of the ulcer with a pathogen with inherent resistance to amikacin and teicoplanin
* Known osteomyelitis
* Known erysipelas
* Known phlegmon
* Complicated deep tissue infection not solely treatable with PRF plus antimicrobial therapy in the opinion of a senior infectious diseases specialist
* Planned systemic antimicrobial therapy
* Active viral hepatitis (A/B/C) or active HIV infection or active syphilis
* Increased sensitivity to amikacin or teicoplanin, PHMB or macrogolol
* Increased sensitivity to tramexanic acid or batroxobin
* Presence of neoplastic growth in the ulcer
* Thrombocytopenic patients (\<150.000 G/L)
* Haemoglobin \< 95 g/L
* Known pregnancy or lactation
* Severe renal impairment (creatinine clearance \<30 ml/min)
* History or clinical signs of impairment of the cochlea or vestibularis system
* Neuromuscular diseases (i.e. Myasthenia gravis, Parkinson's disease)
* Aminoglycoside treatment less than four weeks before inclusion
* Other reasons opposing the study participation on the discretion of the investigators
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02652169
Study Brief:
Protocol Section:
NCT02652169