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

NCT04838600 | Terminated

• 1 other identifier: PN-00025
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 7

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.

Conditions

Chronic Leg Ulcer; Chronic Diabetic Foot Ulcer

Keywords

Leg ulcer; DFU; ChloraSolv; Debridement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Relative change in devitalized tissue and wound size at End of Treatment, compared to Baseline, assessed by planimetry

  1 - 24 weeks

Interventions

ChloraSolv DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Known allergy/hypersensitivity to any of the components of ChloraSolv
• Renal insufficiency defined as serum creatinine \>200 μmol/L
• Macroangiopathy expected to demand vascular intervention or percutaneous angioplasty performed less than 3 months after start of treatment; toe pressure \<30mm Hg
• Kidney or pancreas transplanted
• Patient under cortisone treatment \>60mg/day
• Patient treated with chemotherapy or any other immune-inhibiting drugs 12 months before start of treatment
• Other identified on-going pathologies in the area of wound, such as cancer
• Pregnancy or breastfeeding
• Subjects included in other ongoing clinical investigations which could interfere with this investigation, as judged by the investigator
• 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.

Sponsors & Collaborators

• RLS Global: lead

Study Sites (7)

Vårdcentralen Tunafors

Eskilstuna, Sweden

Location

Capio Lundby Sjukhus

Gothenburg, Sweden

Location

Carlanderska Hospital

Gothenburg, Sweden

Location

Wästerläkarna

Gothenburg, Sweden

Location

Wetterhälsan Munksjöstaden

Jönköping, Sweden

Location

Orthopedic Clinic Mölndal Hospital

Mölndal, Sweden

Location

Framtidens vårdavdelning

Trelleborg, Sweden

Location

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Anders Jönsson, MD

  Orthopedic Clinic Mölndal Hospital Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 9, 2021
• Study Start: June 7, 2021
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (7)