Pressure UlcerNCT05547191
Evaluate Efficacy and Safety of ChloraSolv When Treating Pressure Ulcers in Need of Debridement
A study testing ChloraSolv in people with Pressure Ulcer, run by RLS Global at 6 sites in 3 countries.
Trial summary
This is an open, single-arm, multicentre and interventional investigation to evaluate the debriding effect of ChloraSolv when used on pressure ulcers in need of debridement. Approximately 54 subjects will be enrolled to have 47 evaluable subjects (calculated dropout range 15%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- ChloraSolv
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 1 Sep 2023to 20 Nov 2023
- Phase
- Interventional
- 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
Who may be able to join
- Pressure ulcer 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 written informed consent. If written consent is not possible due to the condition of the patient, one impartial witness shall sign and date the informed consent.
Who cannot join
- Known allergy/hypersensitivity to any of the components of ChloraSolv
- 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
- Wound requiring more than two (2) ChloraSolv syringes for one treatment
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United Kingdom4 sites
Buckinghamshire Healthcare NHS Trust
Aylesbury, England, HP21 8AL
Greater Glasgow Health Board
Glasgow, Scotland, G12 OXH
Liverpool University Hospitals NHS Foundation Trust
Liverpool, England, L7 8XP
East London NHS Foundation Trust
Newham, England, E18DE
Aland Islands1 site
Kirurgkliniken, Ålands hälso- och sjukvård
Mariehamn, Åland, 22111
About this study
Official title: An Open, Single-arm, Multicentre and Interventional Investigation to Evaluate the Debriding Effect of ChloraSolv® on Pressure Ulcers in Need of Debridement
This is an open, single-arm, multicentre and interventional investigation to evaluate the debriding effect of ChloraSolv when used on pressure ulcers in need of debridement. Approximately 54 subjects will be enrolled to have 47 evaluable subjects (calculated dropout range 15%).
ChloraSolv will be applied 1-2 times per week for 12 weeks or until the wound is deemed clean, whichever occurs first i.e. End of Treatment. A Follow-up visit for wound status evaluation will be performed 6 weeks from End of Treatment. Total time in investigation will be maximum 12+6 weeks.
Read more
Subjects will attend a baseline visit to assess eligibility and collect demographic and baseline data and initiate treatment. Photographs of the wound pre and post debridement will be taken at baseline, every week during the treatment period, at End of Treatment and at the Follow-up visit. Photographs will be used to calculate (by PictZar digital planimetry system) the area of devitalized tissue in the wound as well as wound size and calculation of volume.
Wound depth and undermining will be estimated by the investigator at all investigational visits.
A treatment diary will be used in-between the weekly investigational visits to collect any further treatments. The treatment diary will also be filled-in during the follow-up period of 6 weeks.
- Conditions
- Pressure Ulcer
- Being tested
- ChloraSolv
- Keywords
- Pressure ulcer, Debridement, ChloraSolv
- Medical subject headings
- Pressure 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.
| Study group | Role | What they receive |
|---|---|---|
| Investigational device | Experimental | ChloraSolv Receives: Device: ChloraSolv |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of subjects with a clean wound bed, not in need of further debridement at End of Treatment, as assessed by investigator
When the investigator judge that the wound is clean, primary endpoint is reached
Measured: 1-12 weeks
Secondary outcomes (13)
Incidence of subjects with a clean wound bed at End of Treatment, as assessed by planimetry
When the investigator judges that the wound is clean and this is confirmed by planimetry
Measured: 1-12 weeks
Relative change in devitalized tissue at End of Treatment and Follow-up, compared to Baseline, assessed by planimetry
Changes in devitalized tissue, measured by planimetry
Measured: 1-18 weeks
Relative change in wound area at End of Treatment and Follow-up, compared to Baseline and End of Treatment, assessed by planimetry
Changes in wound area, measured by planimetry
Measured: 1-18 weeks
Relative change in volume at End of Treatment and Follow-up, compared to Baseline and End of Treatment, assessed by planimetry
Changes in volume, measured by planimetry
Measured: 1-18 weeks
Relative change in wound depth and undermining at End of Treatment and Follow-up, compared to Baseline, assessed by investigator by using a sterile cotton-tipped applicator
Changes in wound depth (mm) and undermining (mm) will be measured by site personnel using a sterile cotton-tipped applicator and read against a wound ruler.
Measured: 1-18 weeks
Pain during treatment compared to baseline using a Visual Analogue Scale
Changes in pain during treatment from baseline to End of Treatment. Minimum value=0 (No pain), Maximum value=100 (Worst imaginable pain)
Measured: 1-12 weeks
Wound status i.e. clinical signs of infection at all visits
Clinical signs of infection will be documented by ticking off a list with five alternatives/symptoms (redness, heat, edema, pain and odour).Three or more symptoms will be assessed as the subject having clinical signs of infection.
Measured: 1-18 weeks
Treatment period duration with ChloraSolv
Number of weeks that ChloraSolv was used
Measured: 1-12 weeks
Number of treatments with ChloraSolv from Baseline until End of Treatment
Number of treatments with ChloraSolv until end of treatment
Measured: 1-12 weeks
Incidence of subjects with complete wound healing during the investigation period
Number of patients receiving a healed wound
Measured: 1-18 weeks
Incidence of subjects needing sharp debridement during the investigation period and compared to before start of the investigation
Usage of sharp (scalpel or knife) debridement during the investigation period
Measured: 0-18 weeks
Answers from overall evaluation by site personnel
A questionnaire consisting of 5 questions (evaluating the handling/usage of the investigational device) will be filled in by site personnel at end of investigation. There will be four alternatives; Very easy/Easy/Difficult/Very difficult
Measured: Through study completion, an average of 1 year
Answers from overall evaluation by subjects
The subjects will be asked to answer four questions (overall experience with the investigational device) at end of treatment. There will be four alternatives; Very good/Good/Bad/Very Bad
Measured: 1-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start1 Sep 2023
- 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 Pressure 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- RLS Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547191
- Sponsor's protocol ID
- PN-00041
- Other IDs
- 320237
- Status last verified
- Sep 2023
- First submitted
- 16 Sep 2022
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- An Open, Single-arm, Multicentre and Interventional Investigation to Evaluate the Debriding Effect of ChloraSolv® on Pressure Ulcers in Need of Debridement
- ClinicalTrials.gov ID
- NCT05547191
- Acronym / sponsor ID
- PN-00041
- Conditions
- Pressure Ulcer
- Keywords
- Pressure ulcer, Debridement, ChloraSolv
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: RLS Global in bankruptcy
- Enrolment
- 5 participants (actual)
- Lead sponsor
- RLS GlobalIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 21 Sep 2022 (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 an open, single-arm, multicentre and interventional investigation to evaluate the debriding effect of ChloraSolv when used on pressure ulcers in need of debridement. Approximately 54 subjects will be enrolled to have 47 evaluable subjects (calculated dropout range 15%).
ChloraSolv will be applied 1-2 times per week for 12 weeks or until the wound is deemed clean, whichever occurs first i.e. End of Treatment. A Follow-up visit for wound status evaluation will be performed 6 weeks from End of Treatment. Total time in investigation will be maximum 12+6 weeks.
Subjects will attend a baseline visit to assess eligibility and collect demographic and baseline data and initiate treatment. Photographs of the wound pre and post debridement will be taken at baseline, every week during the treatment period, at End of Treatment and at the Follow-up visit. Photographs will be used to calculate (by PictZar digital planimetry system) the area of devitalized tissue in the wound as well as wound size and calculation of volume.
Wound depth and undermining will be estimated by the investigator at all investigational visits.
A treatment diary will be used in-between the weekly investigational visits to collect any further treatments. The treatment diary will also be filled-in during the follow-up period of 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational device | Experimental | Device: ChloraSolvChloraSolv |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pressure ulcer 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 written informed consent. If written consent is not possible due to the condition of the patient, one impartial witness shall sign and date the informed consent.
Key exclusion criteria (5 listed)
- Known allergy/hypersensitivity to any of the components of ChloraSolv
- 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
- Wound requiring more than two (2) ChloraSolv syringes for one treatment
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 | Investigational device |
Primary outcome
Incidence of subjects with a clean wound bed, not in need of further debridement at End of Treatment, as assessed by investigator
Time frame: 1-12 weeks
When the investigator judge that the wound is clean, primary endpoint is reached
13 secondary outcomes
Incidence of subjects with a clean wound bed at End of Treatment, as assessed by planimetry
Time frame: 1-12 weeks
Relative change in devitalized tissue at End of Treatment and Follow-up, compared to Baseline, assessed by planimetry
Time frame: 1-18 weeks
Relative change in wound area at End of Treatment and Follow-up, compared to Baseline and End of Treatment, assessed by planimetry
Time frame: 1-18 weeks
Relative change in volume at End of Treatment and Follow-up, compared to Baseline and End of Treatment, assessed by planimetry
Time frame: 1-18 weeks
Relative change in wound depth and undermining at End of Treatment and Follow-up, compared to Baseline, assessed by investigator by using a sterile cotton-tipped applicator
Time frame: 1-18 weeks
Pain during treatment compared to baseline using a Visual Analogue Scale
Time frame: 1-12 weeks
Wound status i.e. clinical signs of infection at all visits
Time frame: 1-18 weeks
Treatment period duration with ChloraSolv
Time frame: 1-12 weeks
Number of treatments with ChloraSolv from Baseline until End of Treatment
Time frame: 1-12 weeks
Incidence of subjects with complete wound healing during the investigation period
Time frame: 1-18 weeks
Incidence of subjects needing sharp debridement during the investigation period and compared to before start of the investigation
Time frame: 0-18 weeks
Answers from overall evaluation by site personnel
Time frame: Through study completion, an average of 1 year
Answers from overall evaluation by subjects
Time frame: 1-12 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ChloraSolv in people with Pressure Ulcer, run by RLS Global at 6 sites in 3 countries.
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 5 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 6 sites in United Kingdom, Aland Islands, 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 subjects with a clean wound bed, not in need of further debridement at End of Treatment, as assessed by investigator (time frame: 1-12 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.