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

RLS Global

Status: Completed

Conditions: Chronic Ulcer at Lower Leg

Treatments: Device: ChloraSolv

Study type: Interventional

Funder types: Industry

Identifiers

NCT03808181

ChloraSolv 01

Details and patient eligibility

About

The primary objective of this clinical investigation is to evaluate the debriding effect of ChloraSolv® on chronic (more than 1 moth) lower leg ulcer.

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

Active treatment with ChloraSolv

Other group

Description:

Single arm

Treatment:

Device: ChloraSolv