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

NCT ID: NCT04838600

Last Updated: 2023-12-04

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 34 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-07
• Study Completion Date: 2023-11-20

Brief Summary

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.

Detailed Description

As above

Conditions

Chronic Leg Ulcer; Chronic Diabetic Foot Ulcer

Keywords

Leg ulcer; DFU; ChloraSolv; Debridement

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

ChloraSolv

Debridement with ChloraSolv until the wound is visually assessed as clean.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RLS Global

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders Jönsson, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopedic Clinic Mölndal Hospital Sweden

Locations

Vårdcentralen Tunafors

Eskilstuna, , Sweden

Capio Lundby Sjukhus

Gothenburg, , Sweden

Carlanderska Hospital

Gothenburg, , Sweden

Wästerläkarna

Gothenburg, , Sweden

Wetterhälsan Munksjöstaden

Jönköping, , Sweden

Orthopedic Clinic Mölndal Hospital

Mölndal, , Sweden

Framtidens vårdavdelning

Trelleborg, , Sweden

Countries

Sweden

Other Identifiers

PN-00025

Identifier Type: -

Identifier Source: org_study_id