Status:
COMPLETED
An Open, Single-arm, Multi Centre Pilot Investigation to Evaluate the Debriding Effect of ChloraSolv® on Chronic Wounds
Lead Sponsor:
RLS Global
Conditions:
Chronic Ulcer at Lower Leg
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of this clinical investigation is to evaluate the debriding effect of ChloraSolv® on chronic (more than 1 moth) lower leg ulcer.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT03808181
Start Date
January 31 2019
End Date
June 30 2020
Last Update
April 8 2021
Active Locations (9)
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1
Department of Endocrinology Skåne University Hospital Malmö
Malmo, Skåne County, Sweden
2
Primary Care Center Tunafors
Eskilstuna, Sörmland, Sweden, 63188
3
Wästerläkarna Primary Care Center
Gothenburg, Västra Frölunda, Sweden, 42677
4
Carlanderska Sjukhuset
Gothenburg, Västra Götaland County, Sweden, 40545