An Open, Single-arm, Multi Centre Pilot Investigation to Evaluate the Debriding Effect of ChloraSolv® on Chronic Wounds

Approximately 58 subjects from at least two sites in Sweden will be included. Subjects presented with lower leg ulcer, covered with devitalised tissue for 50% or more and being candidate for cleansing, debridement/desloughing will be enrolled. Weekly application of Investigational Product for 6 weeks. Follow-up for wound status evaluation after 12 weeks from baseline. Total time in investigation is 12 weeks.

Inclusion criteria

• Full skin ulcer at lower leg covered with devitalised tissue ≥50%
• Candidate for cleansing, debridement/desloughing
• Wound area ≥2 cm²
• Male or female, 18 years of age and above
• Able to read and understand the Patient Informed Consent and to provide meaningful written informed consent
• Able and willing to follow the Protocol requirements

Exclusion criteria

• Clinical signs of system progression infection with or without ostemyelitis
• Wound located where treatment is not possible
• Subjects not suitable for the investigation according to the investigator's judgment
• Subjects included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator
• Known allergy/hypersensitivity to any of the components of the investigational device
• Pregnant or breast feeding women
• Other significant medical condition that the investigator determines could interfere with compliance or study assessments
• Subjects with wounds of duration less than one month
• Wound area greater than approximately 60 cm²