Chronic Ulcer at Lower LegNCT03808181
An Open, Single-arm, Multi Centre Pilot Investigation to Evaluate the Debriding Effect of ChloraSolv® on Chronic Wounds
A study testing ChloraSolv in people with Chronic Ulcer at Lower Leg, run by RLS Global at 9 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Ulcer at Lower Leg
- What is being tested?
- ChloraSolv
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 9 sitesSweden
- Study dates
- 31 Jan 2019to 30 Jun 2020
- 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
- Full skin ulcer at lower leg covered with devitalised tissue ≥50%
- Candidate for cleansing, debridement/desloughing
- Wound area ≥2 cm²
- 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
- Able and willing to follow the Protocol requirements
Who cannot join
- Clinical signs of system progression infection with or without ostemyelitis
- Wound located where treatment is not possible
- Subjects not suitable for the investigation according to the investigator's judgment
- Subjects included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator
- Known allergy/hypersensitivity to any of the components of the investigational device
- Pregnant or breast feeding women
Show all 9Show fewer
- Other significant medical condition that the investigator determines could interfere with compliance or study assessments
- Subjects with wounds of duration less than one month
- Wound area greater than approximately 60 cm²
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Sweden9 sites
Primary Care Center Tunafors
Eskilstuna, Sörmland, 63188
Wästerläkarna Primary Care Center
Gothenburg, Västra Frölunda, 42677
Carlanderska Sjukhuset
Gothenburg, Västra Götaland County, 40545
Medicinkliniken, Diabetescentrum, Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götaland County, 41345
Närhälsan Olskroken Primary Care Center
Gothenburg, Västra Götaland County, 41665
Department of Endocrinology Skåne University Hospital Malmö
Malmö, Skåne County
Dept of Orthopaedic Surgery
Mölndal, 43180
Hudmottagningen Skaraborgs Sjukhus
Skövde, Västra Götaland County, 54185
Sårcentrum Södersjukhuset Stockholm
Stockholm, 11883
About this study
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
The primary objective of this clinical investigation is to evaluate the debriding effect of ChloraSolv® on chronic (more than 1 moth) lower leg ulcer.
Read the 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.
- Conditions
- Chronic Ulcer at Lower Leg
- Being tested
- ChloraSolv
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloraSolvDevice
Weekly application of ChloraSolv for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active treatment with ChloraSolv | Other | Single arm Receives: Device: ChloraSolv |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start31 Jan 2019
- Primary completion30 Apr 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ulcer at Lower LegStudies 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
- 59 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
- NCT03808181
- Sponsor's protocol ID
- ChloraSolv 01
- Status last verified
- Apr 2021
- First submitted
- 14 Jan 2019
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03808181
- Acronym / sponsor ID
- ChloraSolv 01
- Conditions
- Chronic Ulcer at Lower Leg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- RLS GlobalIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 17 Jan 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active treatment with ChloraSolv | Other | Device: ChloraSolvSingle arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Full skin ulcer at lower leg covered with devitalised tissue ≥50%
- Candidate for cleansing, debridement/desloughing
- Wound area ≥2 cm²
- 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 (9 listed)
- Clinical signs of system progression infection with or without ostemyelitis
- Wound located where treatment is not possible
- Subjects not suitable for the investigation according to the investigator's judgment
- Subjects included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator
- Known allergy/hypersensitivity to any of the components of the investigational device
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 |
|---|---|---|
| ChloraSolvWeekly application of ChloraSolv for 6 weeks | Device | Active treatment with ChloraSolv |
Primary outcome
The primary objective of this clinical investigation is to evaluate the debriding effect of ChloraSolv® on chronic (more than 1 month) lower leg ulcer.
Time frame: 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.
1 secondary outcome
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.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Chronic Ulcer at Lower Leg
RecruitingPhase 4
COMS for Chronic Ulcers Treatment
Venous Leg Ulcer, Wound Heal
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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ChloraSolv in people with Chronic Ulcer at Lower Leg, run by RLS Global at 9 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary objective of this clinical investigation is to evaluate the debriding effect of ChloraSolv® on chronic (more than 1 month) lower leg ulcer. (time frame: 6 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 8 Apr 2021.