Venous Wound UlcersSorbionNCT03020446
Effectiveness of Sorbion in the Treatment of Venous Leg Ulcers The Protocol Elements
A study testing Sorbion Dressing in people with Venous Wound Ulcers, run by University of Toledo Health Science Campus at 1 site in United States.
Trial summary
To follow the effectiveness of Sorbion Dressing in the treatment of highly exuding venous leg ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Wound Ulcers
- What is being tested?
- Sorbion Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- venous leg ulcer
Who cannot join
- pregnant females
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Toledo Medical Center
Toledo, Ohio, 43614
About this study
To follow the effectiveness of Sorbion Dressing in the treatment of highly exuding venous leg ulcers.
Read the detailed description
Wounds will be assessed for inclusion into the study, digital images of the wound will be taken, wound will be cleansed, a sorbion dressing will be placed on wound and a cover dressing with be used to keep in place. The wound will be assessed and a dressing change will take place weekly for 4 weeks. At the final visit a final wound evaluation will be done.
- Conditions
- Venous Wound Ulcers
- Being tested
- Sorbion Dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorbion DressingDevice
Also called Sorbion Sachet sorbion sana
Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sorbion dressing to venous leg ulcer | Experimental | any venous leg ulcer will receive sorbion dressing weekly for 4 weeks than wound will be assessed Receives: Device: Sorbion Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Size
decreased wound bed measured in centimeters
Measured: 4 weeks
Secondary outcomes (2)
Wound Maceration
visual assessment of decreased wound maceration
Measured: 4 weeks
Wound Necrosis
visual assessment of decreased wound necrosis
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startJul 2014
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Provider of product no longer wished to continue with site. No data available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous Wound UlcersStudies 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toledo Health Science Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020446
- Sponsor's protocol ID
- Sorbion Study
- Acronym
- Sorbion
- Status last verified
- Nov 2020
- First submitted
- 7 Oct 2015
- Last updated
- 27 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sorbion in the Treatment of Venous Leg Ulcers The Protocol Elements
- ClinicalTrials.gov ID
- NCT03020446
- Acronym / sponsor ID
- Sorbion / Sorbion Study
- Conditions
- Venous Wound Ulcers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Provider of product no longer wished to continue with site. No data available.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Toledo Health Science CampusUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Posted 27 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To follow the effectiveness of Sorbion Dressing in the treatment of highly exuding venous leg ulcers.
Detailed description
Wounds will be assessed for inclusion into the study, digital images of the wound will be taken, wound will be cleansed, a sorbion dressing will be placed on wound and a cover dressing with be used to keep in place. The wound will be assessed and a dressing change will take place weekly for 4 weeks. At the final visit a final wound evaluation will be done.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorbion dressing to venous leg ulcer | Experimental | Device: Sorbion Dressingany venous leg ulcer will receive sorbion dressing weekly for 4 weeks than wound will be assessed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- venous leg ulcer
Key exclusion criteria (1 listed)
- pregnant females
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 |
|---|---|---|
| Sorbion DressingAlso: Sorbion Sachet sorbion sanaSorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks | Device | Sorbion dressing to venous leg ulcer |
Primary outcome
Wound Size
Time frame: 4 weeks
decreased wound bed measured in centimeters
2 secondary outcomes
Wound Maceration
Time frame: 4 weeks
Wound Necrosis
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Venous Wound Ulcers
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg
Not yet recruiting
Subcutaneous Dexpanthenol Administration and Wound Epithelialization
Chronic Wounds, Diabetic Foot Ulcer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sorbion Dressing in people with Venous Wound Ulcers, run by University of Toledo Health Science Campus at 1 site in United States.
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 1 inclusion and 1 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 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 27 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Wound Size (time frame: 4 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 27 Nov 2020.