Venous LegTHORSDOTTIRNCT06697925
Evaluating the Durability of Closure for Venous Leg Ulcers
An observational study of Venous Leg and Venous Leg Ulcer (VLU), run by Kerecis Ltd. at 1 site in United States.
Trial summary
The goal of this observational study is to determine the durability of closure for venous leg ulcer subjects that achieved closure in the THOR trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg, Venous Leg Ulcer (VLU), Venous Leg Ulcer
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients who achieved closure in during the THOR clinical trial
Who may be able to join
- 1. Subjects must have participated in the THOR trial and achieved complete closure by the 12-week endpoint.
Who cannot join
- 1. Subjects who did not participate in the THOR trial. 2. Subjects who participated in the THOR trial and did not achieve complete closure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Serena Group
Monroeville, Pennsylvania, 15146
Laura Serena, 412-212-0123, lserena@serenagorups.com
About this study
Official title: Prospective Multicenter Observational Study Evaluating the Durability of Closure for Venous Leg Ulcers Following a Randomized, Controlled, Clinical Trial
The goal of this observational study is to determine the durability of closure for venous leg ulcer subjects that achieved closure in the THOR trial.
Read the detailed description
To determine durability of closure (rate of target wound recurrence) of subjects with a closed venous leg ulcer during the THOR clinical trial comparing subjects treated with Intact Fish Skin Graft (IFSG) plus standard of care (SOC) to subjects treated with SOC alone.
- Conditions
- Venous Leg, Venous Leg Ulcer (VLU), Venous Leg Ulcer, Venous Ulcer, VLU
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Thor closure patients | Patients who achieved closure in during the THOR clinical trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Durability of closure
To demonstrate durability of closure (rate of target wound recurrence) of subjects with a closed venous leg ulcer during the THOR clinical trial comparing subjects treated with Intact Fish Skin Graft (IFSG) plus standard of care (SOC) to subjects treated with SOC alone.
Measured: 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study startJan 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kerecis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Serena Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697925
- Sponsor's protocol ID
- KS-1020
- Acronym
- THORSDOTTIR
- Status last verified
- Dec 2024
- First submitted
- 18 Nov 2024
- Last updated
- 24 Jan 2025
- 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 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Observational Study Evaluating the Durability of Closure for Venous Leg Ulcers Following a Randomized, Controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT06697925
- Acronym / sponsor ID
- THORSDOTTIR / KS-1020
- Conditions
- Venous Leg, Venous Leg Ulcer (VLU), Venous Leg Ulcer, Venous Ulcer, VLU
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kerecis Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Serena Group
- Study start
- Jan 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Nov 2024 (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 goal of this observational study is to determine the durability of closure for venous leg ulcer subjects that achieved closure in the THOR trial.
Detailed description
To determine durability of closure (rate of target wound recurrence) of subjects with a closed venous leg ulcer during the THOR clinical trial comparing subjects treated with Intact Fish Skin Graft (IFSG) plus standard of care (SOC) to subjects treated with SOC alone.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thor closure patients | – | –Patients who achieved closure in during the THOR clinical trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who achieved closure in during the THOR clinical trial
Key inclusion criteria (1 listed)
- 1. Subjects must have participated in the THOR trial and achieved complete closure by the 12-week endpoint.
Key exclusion criteria (1 listed)
- 1. Subjects who did not participate in the THOR trial. 2. Subjects who participated in the THOR trial and did not achieve complete closure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Durability of closure
Time frame: 12-month follow-up
To demonstrate durability of closure (rate of target wound recurrence) of subjects with a closed venous leg ulcer during the THOR clinical trial comparing subjects treated with Intact Fish Skin Graft (IFSG) plus standard of care (SOC) to subjects treated with SOC alone.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Venous Leg
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
Not yet recruiting
Mindfulness Intervention on Minimally Invasive Vascular Surgery
Anxiety, Pain
Active, not recruitingObservational study
Pain During Heat Treatment for Lower Extremity Varicose Veins: Radiofrequency vs. Microwave
Lower Extremity Varicose Veins, Radiofrequency Ablation
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Leg and Venous Leg Ulcer (VLU), run by Kerecis Ltd. 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: looking for participants now, as of the sponsor's last update on 24 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bennett Rogers (888-960-1343 ext. 1008, brogers@serenagroups.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Durability of closure (time frame: 12-month follow-up). 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 24 Jan 2025.