An Open, Single-arm, Multi Centre Pilot Investigation to Evaluate the Debriding Effect of ChloraSolv® on Chronic Wounds
- Conditions
- Chronic Ulcer at Lower Leg
- Interventions
- Device: ChloraSolv
- Registration Number
- NCT03808181
- Lead Sponsor
- RLS Global
- 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.
- Detailed Description
Approximately 58 subjects from at least two sites in Sweden will be included. Subjects presented with lower leg ulcer, covered with devitalised tissue for 50% or more and being candidate for cleansing, debridement/desloughing will be enrolled. Weekly application of Investigational Product for 6 weeks. Follow-up for wound status evaluation after 12 weeks from baseline. Total time in investigation is 12 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Active treatment with ChloraSolv ChloraSolv Single arm
- Primary Outcome Measures
Name Time Method The primary objective of this clinical investigation is to evaluate the debriding effect of ChloraSolv® on chronic (more than 1 month) lower leg ulcer. 6 weeks 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.
- Secondary Outcome Measures
Name Time Method 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 The objectives to evaluate change of devitalised tissue and change in wound area will be assessed by planimetry (photography) prior to and after each debridement. The photos will be sent for evaluation by an independent assessor. Pain during treatment will be assessed by the patient using a Visual Analogue Scale (VAS) for pain. The condition of the wound, need for sharp debridement, overall evaluation of the product and safety parameters are assessed by the health care professional treating the patient and the information is collected in the Case Report Form (CRF)
Trial Locations
- Locations (9)
Hudmottagningen Skaraborgs Sjukhus
🇸🇪Skövde, Västra Götaland, Sweden
Dept of Orthopaedic Surgery
🇸🇪Mölndal, Sweden
Carlanderska Sjukhuset
🇸🇪Göteborg, Västra Götaland, Sweden
Medicinkliniken, Diabetescentrum, Sahlgrenska Universitetssjukhuset
🇸🇪Göteborg, Västra Götaland, Sweden
Department of Endocrinology Skåne University Hospital Malmö
🇸🇪Malmö, Skåne, Sweden
Primary Care Center Tunafors
🇸🇪Eskilstuna, Sörmland, Sweden
Wästerläkarna Primary Care Center
🇸🇪Göteborg, Västra Frölunda, Sweden
Närhälsan Olskroken Primary Care Center
🇸🇪Göteborg, Västra Götaland, Sweden
Sårcentrum Södersjukhuset Stockholm
🇸🇪Stockholm, Sweden