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

NCT03808181 | Completed

• 1 other identifier: ChloraSolv 01
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Chronic Ulcer at Lower Leg

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

  12 weeks

Study Arms (1)

Active treatment with ChloraSolv

OTHER

Single arm

Device: ChloraSolv

Interventions

ChloraSolv DEVICE

Weekly application of ChloraSolv for 6 weeks

Active treatment with ChloraSolv

Eligibility Criteria

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

You may qualify if:

• Full skin ulcer at lower leg covered with devitalised tissue ≥50%
• Candidate for cleansing, debridement/desloughing
• Wound area ≥2 cm²
• 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
• Able and willing to follow the Protocol requirements

You may not qualify if:

• Clinical signs of system progression infection with or without ostemyelitis
• Wound located where treatment is not possible
• Subjects not suitable for the investigation according to the investigator's judgment
• Subjects included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator
• Known allergy/hypersensitivity to any of the components of the investigational device
• Pregnant or breast feeding women
• Other significant medical condition that the investigator determines could interfere with compliance or study assessments
• Subjects with wounds of duration less than one month
• Wound area greater than approximately 60 cm²

Sponsors & Collaborators

• RLS Global: lead

Study Sites (9)

Department of Endocrinology Skåne University Hospital Malmö

Malmo, Skåne County, Sweden

Location

Primary Care Center Tunafors

Eskilstuna, Sörmland, 63188, Sweden

Location

Wästerläkarna Primary Care Center

Gothenburg, Västra Frölunda, 42677, Sweden

Location

Carlanderska Sjukhuset

Gothenburg, Västra Götaland County, 40545, Sweden

Location

Medicinkliniken, Diabetescentrum, Sahlgrenska Universitetssjukhuset

Gothenburg, Västra Götaland County, 41345, Sweden

Location

Närhälsan Olskroken Primary Care Center

Gothenburg, Västra Götaland County, 41665, Sweden

Location

Hudmottagningen Skaraborgs Sjukhus

Skövde, Västra Götaland County, 54185, Sweden

Location

Dept of Orthopaedic Surgery

Mölndal, 43180, Sweden

Location

Sårcentrum Södersjukhuset Stockholm

Stockholm, 11883, Sweden

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 17, 2019
• Study Start: January 31, 2019
• Primary Completion: April 30, 2020
• Study Completion: June 30, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (9)