Chronic Leg UlcerChloraSolv02NCT04838600
A PMCF Investigation on Chronic LU and DFU in Need of Debridement With ChloraSolv®
An observational study of Chronic Leg Ulcer and Chronic Diabetic Foot Ulcer, run by RLS Global at 7 sites in Sweden.
Trial 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 65 subjects will be enrolled (calculated dropout range 20%) from at least 6-12 sites in Sweden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Leg Ulcer, Chronic Diabetic Foot Ulcer
- What is being tested?
- ChloraSolv
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 7 sitesSweden
- Study dates
- 7 Jun 2021to 20 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigation population will comprise of 65 subjects fulfilling the eligibility criteria of the PMCF investigation.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Sweden7 sites
Vårdcentralen Tunafors
Eskilstuna
Capio Lundby Sjukhus
Gothenburg
Carlanderska Hospital
Gothenburg
Wästerläkarna
Gothenburg
Wetterhälsan Munksjöstaden
Jönköping
Orthopedic Clinic Mölndal Hospital
Mölndal
Framtidens vårdavdelning
Trelleborg
About this study
Official title: A Multicenter, Prospective, Observational, Post-Market Clinical Follow-up Investigation to Confirm Clinical Performance and Safety of ChloraSolv® When Used on Chronic Leg Ulcers and Chronic Diabetic Foot Ulcers in Need of Debridement
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 65 subjects will be enrolled (calculated dropout range 20%) from at least 6-12 sites in Sweden. Subjects presented with chronic leg ulcers and chronic diabetic foot ulcers in need of debridement will be enrolled and receive application of ChloraSolv per clinical routine at treating site and in accordance with the ChloraSolv Instruction for Use for up to 24 weeks. Subjects will attend a baseline visit to assess eligibility and collect demographic and baseline data and initiate treatment. There will be two follow up visits in the investigation. The first follow up visit will take place at End of Treatment, as based on investigator judgement and clinical routine at the treating site, maximum 24 weeks post baseline per the IFU. After End of Treatment, subjects will continue in the investigation with wound management per clinical routine at the treating sites for 6 weeks. At 6 weeks post End of Treatment, subjects will attend a Follow-up visit to assess safety, wound status and relative change in wound size. Besides confirmation of the clinical performance and safety when used in a larger population the investigation also includes analysis of treatment period duration. Additionally, health economy parameters will be analyzed. The investigation will be monitored to confirm the already known precautions as well as identify new precautions and possible contraindications for the use of the device. Photography of the wound pre and post debridement will be performed to confirm wound size and amount of devitalized tissue in the wound.
Read the detailed description
As above
- Conditions
- Chronic Leg Ulcer, Chronic Diabetic Foot Ulcer
- Being tested
- ChloraSolv
- Keywords
- Leg ulcer, DFU, ChloraSolv, Debridement
- Medical subject headings
- Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloraSolvDevice
Debridement with ChloraSolv until the wound is visually assessed as clean.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clean wound bed at End of Treatment, as assessed by investigator
When the investigator judges that the wound is clean primary endpoint is reached and confirmed by planimetry.
Measured: 1 - 24 weeks
Secondary outcomes (1)
Relative change in devitalized tissue and wound size at End of Treatment, compared to Baseline, assessed by planimetry
Assessed by planimetry
Measured: 1 - 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start7 Jun 2021
- Primary completion20 Nov 2023
- Study completion20 Nov 2023
Why it stopped: RLS Global in bankruptcy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- RLS Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anders Jönsson, MD, Principal investigator, Orthopedic Clinic Mölndal Hospital Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838600
- Sponsor's protocol ID
- PN-00025
- Acronym
- ChloraSolv02
- Status last verified
- Aug 2023
- First submitted
- 6 Apr 2021
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an observational study required by the notified body to confirm clinical performance and safety.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Observational, Post-Market Clinical Follow-up Investigation to Confirm Clinical Performance and Safety of ChloraSolv® When Used on Chronic Leg Ulcers and Chronic Diabetic Foot Ulcers in Need of Debridement
- ClinicalTrials.gov ID
- NCT04838600
- Acronym / sponsor ID
- ChloraSolv02 / PN-00025
- Conditions
- Chronic Leg Ulcer, Chronic Diabetic Foot Ulcer
- Keywords
- Leg ulcer, DFU, ChloraSolv, Debridement
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: RLS Global in bankruptcy
- Enrolment
- 34 participants (actual)
- Lead sponsor
- RLS GlobalIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 65 subjects will be enrolled (calculated dropout range 20%) from at least 6-12 sites in Sweden. Subjects presented with chronic leg ulcers and chronic diabetic foot ulcers in need of debridement will be enrolled and receive application of ChloraSolv per clinical routine at treating site and in accordance with the ChloraSolv Instruction for Use for up to 24 weeks. Subjects will attend a baseline visit to assess eligibility and collect demographic and baseline data and initiate treatment. There will be two follow up visits in the investigation. The first follow up visit will take place at End of Treatment, as based on investigator judgement and clinical routine at the treating site, maximum 24 weeks post baseline per the IFU. After End of Treatment, subjects will continue in the investigation with wound management per clinical routine at the treating sites for 6 weeks. At 6 weeks post End of Treatment, subjects will attend a Follow-up visit to assess safety, wound status and relative change in wound size. Besides confirmation of the clinical performance and safety when used in a larger population the investigation also includes analysis of treatment period duration. Additionally, health economy parameters will be analyzed. The investigation will be monitored to confirm the already known precautions as well as identify new precautions and possible contraindications for the use of the device. Photography of the wound pre and post debridement will be performed to confirm wound size and amount of devitalized tissue in the wound.
Detailed description
As above
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigation population will comprise of 65 subjects fulfilling the eligibility criteria of the PMCF investigation.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChloraSolvDebridement with ChloraSolv until the wound is visually assessed as clean. | Device | – |
Primary outcome
Incidence of clean wound bed at End of Treatment, as assessed by investigator
Time frame: 1 - 24 weeks
When the investigator judges that the wound is clean primary endpoint is reached and confirmed by planimetry.
1 secondary outcome
Relative change in devitalized tissue and wound size at End of Treatment, compared to Baseline, assessed by planimetry
Time frame: 1 - 24 weeks
Results and safety
The study was stopped early (reason given: RLS Global in bankruptcy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: No. This is an observational study required by the notified body to confirm clinical performance and safety.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Jönsson, MD principal investigator
Orthopedic Clinic Mölndal Hospital Sweden
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Leg Ulcer and Chronic Diabetic Foot Ulcer, run by RLS Global at 7 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: RLS Global in bankruptcy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clean wound bed at End of Treatment, as assessed by investigator (time frame: 1 - 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.