Clinical trial NCT03808181: An Open, Single-arm, Multi Centre Pilot Investigation to Evaluate the Debriding Effect of ChloraSolv® on Chronic Wounds
Official title: An Open, Single-arm, Multi Centre Pilot Investigation to Evaluate the Debriding Effect of ChloraSolv® on Chronic Wounds, Covered With Devitalised Tissue, During Six Weeks Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Ulcer at Lower Leg
Lead sponsor: RLS Global
Sponsor class: INDUSTRY
First posted: 2019-01-17
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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, 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: The primary objective of this clinical investigation is to evaluate the debriding effect of ChloraSolv® on chronic (more than 1 month) lower leg ulcer.
timeFrame: 6 weeks
Secondary outcomes:
measure: The secondary objectives are to evaluate change of devitalised tissue, change in wound area, pain during treatment, condition of the wound, need for sharp debridement and overall evaluation of the product and safety parameters.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Department of Endocrinology Skåne University Hospital Malmö
state: Skåne
city: Eskilstuna
country: Sweden
facility: Primary Care Center Tunafors
state: Sörmland
city: Göteborg
country: Sweden
facility: Wästerläkarna Primary Care Center
state: Västra Frölunda
city: Göteborg
country: Sweden
facility: Carlanderska Sjukhuset
state: Västra Götaland
city: Göteborg
country: Sweden
facility: Medicinkliniken, Diabetescentrum, Sahlgrenska Universitetssjukhuset
state: Västra Götaland
city: Göteborg
country: Sweden
facility: Närhälsan Olskroken Primary Care Center
state: Västra Götaland
city: Skövde
country: Sweden
facility: Hudmottagningen Skaraborgs Sjukhus
state: Västra Götaland
city: Mölndal
country: Sweden
facility: Dept of Orthopaedic Surgery
city: Stockholm
country: Sweden
facility: Sårcentrum Södersjukhuset Stockholm
Study officials:
References: