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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Ulcer at Lower Leg
• Intervention / Treatment: Device: ChloraSolv

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 Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Mölndal, Sweden, 43180
    • Dept of Orthopaedic Surgery
  • Stockholm, Sweden, 11883
    • Sårcentrum Södersjukhuset Stockholm
  • Skåne
    • Malmö, Skåne, Sweden
      • Department of Endocrinology Skåne University Hospital Malmö
  • Sörmland
    • Eskilstuna, Sörmland, Sweden, 63188
      • Primary Care Center Tunafors
  • Västra Frölunda
    • Göteborg, Västra Frölunda, Sweden, 42677
      • Wästerläkarna Primary Care Center
  • Västra Götaland
    • Göteborg, Västra Götaland, Sweden, 40545
      • Carlanderska sjukhuset
    • Göteborg, Västra Götaland, Sweden, 41345
      • Medicinkliniken, Diabetescentrum, Sahlgrenska Universitetssjukhuset
    • Göteborg, Västra Götaland, Sweden, 41665
      • Närhälsan Olskroken Primary Care Center
    • Skövde, Västra Götaland, Sweden, 54185
      • Hudmottagningen Skaraborgs Sjukhus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Active treatment with ChloraSolv; Single arm	Device: ChloraSolv; Weekly application of ChloraSolv for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary objective of this clinical investigation is to evaluate the debriding effect of ChloraSolv® on chronic (more than 1 month) lower leg ulcer.	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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	12 weeks

Collaborators and Investigators

• Sponsor: RLS Global

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2019
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 17, 2019

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ChloraSolv 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No