NCT04838600

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 34 (actual)
• Sponsor: RLS Global · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	ChloraSolv	Debridement with ChloraSolv until the wound is visually assessed as clean.

Timeline

• Start date: 2021-06-07
• Primary completion: 2023-11-20
• Completion: 2023-11-20
• First posted: 2021-04-09
• Last updated: 2023-12-04

Locations

7 sites across 1 country: Sweden