Chronic Ulcer at Lower Leg
Conditions
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.
Interventions
DEVICEChloraSolv
Weekly application of ChloraSolv for 6 weeks
Sponsors
RLS Global
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Full skin ulcer at lower leg covered with devitalised tissue ≥50% 2. Candidate for cleansing, debridement/desloughing 3. Wound area ≥2 cm² 4. Male or female, 18 years of age and above 5. Able to read and understand the Patient Informed Consent and to provide meaningful written informed consent 6. Able and willing to follow the Protocol requirements
Exclusion criteria
1. Clinical signs of system progression infection with or without ostemyelitis 2. Wound located where treatment is not possible 3. Subjects not suitable for the investigation according to the investigator's judgment 4. Subjects included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator 5. Known allergy/hypersensitivity to any of the components of the investigational device 6. Pregnant or breast feeding women 7. Other significant medical condition that the investigator determines could interfere with compliance or study assessments 8. Subjects with wounds of duration less than one month 9. Wound area greater than approximately 60 cm²
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Sweden
Outcome results
None listed