Chronic Ulcer at Lower Leg Clinical Trial
Official title:
An Open, Single-arm, Multi Centre Pilot Investigation to Evaluate the Debriding Effect of ChloraSolv® on Chronic Wounds, Covered With Devitalised Tissue, During Six Weeks Treatment
| Verified date | April 2021 |
| Source | RLS Global |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objective of this clinical investigation is to evaluate the debriding effect of ChloraSolv® on chronic (more than 1 moth) lower leg ulcer.
| Status | Completed |
| Enrollment | 59 |
| Est. completion date | June 30, 2020 |
| Est. primary completion date | April 30, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Primary Care Center Tunafors | Eskilstuna | Sörmland |
| Sweden | Carlanderska Sjukhuset | Göteborg | Västra Götaland |
| Sweden | Medicinkliniken, Diabetescentrum, Sahlgrenska Universitetssjukhuset | Göteborg | Västra Götaland |
| Sweden | Närhälsan Olskroken Primary Care Center | Göteborg | Västra Götaland |
| Sweden | Wästerläkarna Primary Care Center | Göteborg | Västra Frölunda |
| Sweden | Department of Endocrinology Skåne University Hospital Malmö | Malmö | Skåne |
| Sweden | Dept of Orthopaedic Surgery | Mölndal | |
| Sweden | Hudmottagningen Skaraborgs Sjukhus | Skövde | Västra Götaland |
| Sweden | Sårcentrum Södersjukhuset Stockholm | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| RLS Global |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. | 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) | 12 weeks |