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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2020-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chronic Ulcer at Lower Leg

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active treatment with ChloraSolv

Single arm

Group Type OTHER

ChloraSolv

Intervention Type DEVICE

Weekly application of ChloraSolv for 6 weeks

Interventions

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ChloraSolv

Weekly application of ChloraSolv for 6 weeks

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No