A PMCF Investigation on Chronic LU and DFU in Need of Debridement With ChloraSolv® (ChloraSolv02)

A Multicenter, Prospective, Observational, Post-Market Clinical Follow-up Investigation to Confirm Clinical Performance and Safety of ChloraSolv® When Used on Chronic Leg Ulcers and Chronic Diabetic Foot Ulcers in Need of Debridement

This is a single-arm, observational, multicenter PMCF investigation designed to confirm clinical performance and safety of ChloraSolv when exposed to larger population of clinical users. Approximately 65 subjects will be enrolled (calculated dropout range 20%) from at least 6-12 sites in Sweden. Subjects presented with chronic leg ulcers and chronic diabetic foot ulcers in need of debridement will be enrolled and receive application of ChloraSolv per clinical routine at treating site and in accordance with the ChloraSolv Instruction for Use for up to 24 weeks. Subjects will attend a baseline visit to assess eligibility and collect demographic and baseline data and initiate treatment. There will be two follow up visits in the investigation. The first follow up visit will take place at End of Treatment, as based on investigator judgement and clinical routine at the treating site, maximum 24 weeks post baseline per the IFU. After End of Treatment, subjects will continue in the investigation with wound management per clinical routine at the treating sites for 6 weeks. At 6 weeks post End of Treatment, subjects will attend a Follow-up visit to assess safety, wound status and relative change in wound size. Besides confirmation of the clinical performance and safety when used in a larger population the investigation also includes analysis of treatment period duration. Additionally, health economy parameters will be analyzed. The investigation will be monitored to confirm the already known precautions as well as identify new precautions and possible contraindications for the use of the device. Photography of the wound pre and post debridement will be performed to confirm wound size and amount of devitalized tissue in the wound.

Study Overview

• Status: Terminated
• Conditions: Chronic Diabetic Foot Ulcer; Chronic Leg Ulcer
• Intervention / Treatment: Device: ChloraSolv

Detailed Description

As above

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

• Study Contact: Name: Caroline Gröndahl, MSc; Phone Number: +46764194910; Email: caroline.grondahl@rlsglobal.se

Study Locations

• Sweden
  • Eskilstuna, Sweden
    • Vårdcentralen Tunafors
  • Gothenburg, Sweden
    • Capio Lundby Sjukhus
  • Göteborg, Sweden
    • Carlanderska Hospital
  • Göteborg, Sweden
    • Wästerläkarna
  • Jönköping, Sweden
    • Wetterhälsan Munksjöstaden
  • Mölndal, Sweden
    • Orthopedic Clinic Mölndal Hospital
  • Trelleborg, Sweden
    • Framtidens vårdavdelning

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

The investigation population will comprise of 65 subjects fulfilling the eligibility criteria of the PMCF investigation.

Description

Inclusion Criteria:

1. Chronic leg ulcers and chronic diabetic foot ulcers in need of debridement
2. Male or female, 18 years of age and above
3. Able to read and understand the Patient Informed Consent and to provide meaningful written informed consent

Exclusion Criteria:

1. Known allergy/hypersensitivity to any of the components of ChloraSolv
2. Renal insufficiency defined as serum creatinine >200 μmol/L
3. Macroangiopathy expected to demand vascular intervention or percutaneous angioplasty performed less than 3 months after start of treatment; toe pressure <30mm Hg
4. Kidney or pancreas transplanted
5. Patient under cortisone treatment >60mg/day
6. Patient treated with chemotherapy or any other immune-inhibiting drugs 12 months before start of treatment
7. Other identified on-going pathologies in the area of wound, such as cancer
8. Pregnancy or breastfeeding
9. Subjects included in other ongoing clinical investigations which could interfere with this investigation, as judged by the investigator
10. Subjects not suitable for the investigation according to the investigator's judgment or other significant medical conditions that the investigator determines could interfere with compliance or investigation assessments.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of clean wound bed at End of Treatment, as assessed by investigator	When the investigator judges that the wound is clean primary endpoint is reached and confirmed by planimetry.	1 - 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change in devitalized tissue and wound size at End of Treatment, compared to Baseline, assessed by planimetry	Assessed by planimetry	1 - 24 weeks

Collaborators and Investigators

• Sponsor: RLS Global
• Investigators: Principal Investigator: Anders Jönsson, MD, Orthopedic Clinic Mölndal Hospital Sweden

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Actual): November 20, 2023
• Study Completion (Actual): November 20, 2023

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: DFU; Debridement; ChloraSolv; Leg ulcer
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Leg Ulcer
• Other Study ID Numbers: PN-00025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is an observational study required by the notified body to confirm clinical performance and safety.

Drug and device information, study documents

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