Status:
TERMINATED
A PMCF Investigation on Chronic LU and DFU in Need of Debridement With ChloraSolv®
Lead Sponsor:
RLS Global
Conditions:
Chronic Leg Ulcer
Chronic Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
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...
Detailed Description
As above
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
June 7 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 20 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04838600
Start Date
June 7 2021
End Date
November 20 2023
Last Update
December 4 2023
Active Locations (7)
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1
Vårdcentralen Tunafors
Eskilstuna, Sweden
2
Capio Lundby Sjukhus
Gothenburg, Sweden
3
Carlanderska Hospital
Gothenburg, Sweden
4
Wästerläkarna
Gothenburg, Sweden