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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03808181
Recruitment Status : Completed
First Posted : January 17, 2019
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
RLS Global

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Ulcer at Lower Leg Device: ChloraSolv Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 31, 2019
Actual Primary Completion Date : April 30, 2020
Actual Study Completion Date : June 30, 2020

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Arms and Interventions
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Arm Intervention/treatment
Active treatment with ChloraSolv
Single arm
 Device: ChloraSolv
Weekly application of ChloraSolv for 6 weeks


Outcome Measures
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Primary Outcome Measures :
  1. The primary objective of this clinical investigation is to evaluate the debriding effect of ChloraSolv® on chronic (more than 1 month) lower leg ulcer. [ Time Frame: 6 weeks ]
    The debriding effect of ChloraSolv® will be assessed by planimetry (photography) prior to and after each debridement. The photos will be sent for evaluation by an independent assessor.


Secondary Outcome Measures :
  1. 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. [ Time Frame: 12 weeks ]
    The objectives to evaluate change of devitalised tissue and change in wound area will be assessed by planimetry (photography) prior to and after each debridement. The photos will be sent for evaluation by an independent assessor. Pain during treatment will be assessed by the patient using a Visual Analogue Scale (VAS) for pain. The condition of the wound, need for sharp debridement, overall evaluation of the product and safety parameters are assessed by the health care professional treating the patient and the information is collected in the Case Report Form (CRF)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03808181


Locations
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Sweden
Department of Endocrinology Skåne University Hospital Malmö
Malmö, Skåne, Sweden
Primary Care Center Tunafors
Eskilstuna, Sörmland, Sweden, 63188
Wästerläkarna Primary Care Center
Göteborg, Västra Frölunda, Sweden, 42677
Carlanderska Sjukhuset
Göteborg, Västra Götaland, Sweden, 40545
Medicinkliniken, Diabetescentrum, Sahlgrenska Universitetssjukhuset
Göteborg, Västra Götaland, Sweden, 41345
Närhälsan Olskroken Primary Care Center
Göteborg, Västra Götaland, Sweden, 41665
Hudmottagningen Skaraborgs Sjukhus
Skövde, Västra Götaland, Sweden, 54185
Dept of Orthopaedic Surgery
Mölndal, Sweden, 43180
Sårcentrum Södersjukhuset Stockholm
Stockholm, Sweden, 11883
Sponsors and Collaborators
RLS Global
More Information
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Responsible Party: RLS Global
ClinicalTrials.gov Identifier: NCT03808181    
Other Study ID Numbers: ChloraSolv 01
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No