Venous Leg Ulcer (VLU)Phase 4THORNCT06693570
Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers
A Phase 4 study of Venous Leg Ulcer (VLU) and Venous Leg Ulcers, run by Kerecis Ltd. at 1 site in United States.
Trial summary
The purpose of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of hard-to-heal venous leg ulcers (VLU) between Intact Fish Skin Graft plus standard of care (IFSG/SOC) versus standard of care alone (SOC) over 12 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer (VLU), Venous Leg Ulcers, Venous Leg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2024to Nov 2026
- Phase
- Phase 4
- 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
Who may be able to join
- Subjects must be at least 18 years of age or older.
- Subjects must have a nonhealing venous leg ulcer present for a minimum of 4 weeks and cannot have received more than 52 weeks of high-level compression prior to the initial screening visit.
- No visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.
- At randomization, subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 25 cm2 measured post-debridement.
- The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
- ABI between 0.7 and ≤ 1.3;
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- TBI ≥ 0.6;
- TCOM ≥ 40 mmHg;
- PVR: biphasic.
- If the potential subject has two or more ulcers, and they are separated by at least 2 cm post-debridement, the largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer. If the potential subject has two or more ulcers and they are separated by less than 2cm, the entire wound area is designated as the target ulcer.
- Subjects must have a Functional Ambulatory Category Score (FACS) of 3 or greater.
- Subjects must consent to using the prescribed compression method for the duration of the study.
- Subjects must agree to attend the weekly study visits required by the protocol.
- Subjects must be willing and able to participate in the informed consent process.
Who cannot join
- The potential subject is known to have a life expectancy of < 6 months.
- The index ulcer is determined to be due to a condition other than venous insufficiency.
- The target ulcer exposes muscle, tendon, or bone.
- The target ulcer exhibits overt clinical signs and symptoms of infection with cellulitis surrounding the wound margin.
- The target ulcer has known or suspected skin malignancy.
- The target ulcer has been previously exposed to radiation.
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- The target ulcer duration is greater than one year having received high level compression without closure for a year or more.
- The potential subject has end stage renal disease requiring dialysis.
- The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
- A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
- The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a cellular or tissue-based product (CTP) in the 30 days prior to the initial screening visit.
- The potential subject has a malnutrition indicator score <17 as measured on the Mini Nutritional Assessment.
- The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
- The surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). Digital planimetry is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).
- The surface area measurement of the target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.
- The potential subject has a Functional Ambulatory Category Score (FACS) of less than 3.
- The potential subject has a body mass index (BMI) greater than 42
- In the last 8 weeks the patient has undergone revascularization (surgical or stenting) to the affected leg.
- Venous intervention in the affected limb in the last 30 days.
- Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator.
- Pregnancy at enrollment or women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
- Know allergy to any of the components of fish skin or bovine collagen.
- Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
- A subject with a disorder that would create unacceptable risk of post-operative complications is excluded.
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
Monroeville, Pennsylvania, 15146
Laura Serena, 412-212-0123, lserena@serenagroups.com
About this study
Official title: A Randomized Controlled Multicenter Clinical Trial Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers
The purpose of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of hard-to-heal venous leg ulcers (VLU) between Intact Fish Skin Graft plus standard of care (IFSG/SOC) versus standard of care alone (SOC) over 12 weeks.
Read the detailed description
This is a randomized controlled multicenter clinical trial evaluating intact fish skin grand and standard of care vs. standard of care alone in nonhealing venous leg ulcers. The product classifies as a medical device and consists of a full thickness fish-skin that has been processed using Kerecis™ Limited's proprietary EnviroIntact™ method.
- Being tested
- Intact Fish Skin Graft (IFSG) + Standard of Care, Standard of Care
- Keywords
- Fish Skin Graft, Intact Fish Skin Graft
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intact Fish Skin Graft (IFSG) + Standard of CareOther
Participants will receive weekly applications of MariGen and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Standard of CareOther
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Intact Fish Skin Graft (IFSG) + Standard of Care | Experimental | Up to 12 visits with Intact Fish Skin Graft (IFSG) + Standard of Care. Receives: Other: Intact Fish Skin Graft (IFSG) + Standard of Care |
| Standard of Care | Active comparator | Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of target ulcers achieving complete wound closure
The percentage of target ulcers achieving complete wound closure in 12 weeks
Measured: [Time Frame: 1-12 Weeks]
Secondary outcomes (7)
Time to closure
The time to closure of the target ulcers over 12 weeks.
Measured: [Time Frame: 1-12 weeks]
Percent area change
Percentage wound area change from TV-1 to TV-13 measured weekly with digital photographic planimetry and physical examination.
Measured: [Time Frame: 1-12 weeks]
Adverse Events
The number of adverse events.
Measured: [Time Frame: 1-12 weeks]
Change in pain in target ulcer
Change in pain in the target ulcer assessed using the Visual Analog Scale VAS scale from TV-1 to TV-13
Measured: [Time Frame: 1-12 weeks]
Visits and product applications needed to close the ulcer
The number of visits and product applications needed to close the ulcer
Measured: [Time Frame: 1-12 weeks]
Quality of life using the Wound quality of Life questionare wQOL
Change in quality of life using the wQOL checklist [TV-1, TV-4, TV-8, and TV-12/Final Visit].
Measured: [Time Frame: 1-12 weeks]
Determine improvement in Quality of Life - Forgotten Wound Score FWS
Quality of Life assessed using the Forgotten Wound Score. The scale has a score of 0 to 100- 100 being the worst outcome meaning the wound bothers the subject most of the time. [TV-1, TV-4, TV-8, and TV-12/Final Visit].
Measured: [Time Frame: 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 posted18 Nov 2024
- Study start25 Nov 2024
- Primary completionApr 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg Ulcer (VLU)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter Prospective Randomized Comparative Effectiveness Clinical Trial
- Masking
- None (open label)
- 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
- NCT06693570
- Sponsor's protocol ID
- KS-1010
- Other IDs
- Pro00081893
- Acronym
- THOR
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 24 Jan 2025
- 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 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Multicenter Clinical Trial Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT06693570
- Acronym / sponsor ID
- THOR / KS-1010
- Keywords
- Fish Skin Graft, Intact Fish Skin Graft
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kerecis Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Serena Group
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 18 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 purpose of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of hard-to-heal venous leg ulcers (VLU) between Intact Fish Skin Graft plus standard of care (IFSG/SOC) versus standard of care alone (SOC) over 12 weeks.
Detailed description
This is a randomized controlled multicenter clinical trial evaluating intact fish skin grand and standard of care vs. standard of care alone in nonhealing venous leg ulcers. The product classifies as a medical device and consists of a full thickness fish-skin that has been processed using Kerecis™ Limited's proprietary EnviroIntact™ method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter Prospective Randomized Comparative Effectiveness Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Intact Fish Skin Graft (IFSG) + Standard of Care | Experimental | Other: Intact Fish Skin Graft (IFSG) + Standard of CareUp to 12 visits with Intact Fish Skin Graft (IFSG) + Standard of Care. |
| Standard of Care | Active comparator | Other: Standard of CareStandard of care will be cleaning, debridement, ulcer moisture balance, and offloading. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects must be at least 18 years of age or older.
- Subjects must have a nonhealing venous leg ulcer present for a minimum of 4 weeks and cannot have received more than 52 weeks of high-level compression prior to the initial screening visit.
- No visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.
- At randomization, subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 25 cm2 measured post-debridement.
- The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
Key exclusion criteria (24 listed)
- The potential subject is known to have a life expectancy of < 6 months.
- The index ulcer is determined to be due to a condition other than venous insufficiency.
- The target ulcer exposes muscle, tendon, or bone.
- The target ulcer exhibits overt clinical signs and symptoms of infection with cellulitis surrounding the wound margin.
- The target ulcer has known or suspected skin malignancy.
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 |
|---|---|---|
| Intact Fish Skin Graft (IFSG) + Standard of CareParticipants will receive weekly applications of MariGen and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | Intact Fish Skin Graft (IFSG) + Standard of Care |
| Standard of CareBeginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first. | Other | Standard of Care |
Primary outcome
The percentage of target ulcers achieving complete wound closure
Time frame: [Time Frame: 1-12 Weeks]
The percentage of target ulcers achieving complete wound closure in 12 weeks
7 secondary outcomes
Time to closure
Time frame: [Time Frame: 1-12 weeks]
Percent area change
Time frame: [Time Frame: 1-12 weeks]
Adverse Events
Time frame: [Time Frame: 1-12 weeks]
Change in pain in target ulcer
Time frame: [Time Frame: 1-12 weeks]
Visits and product applications needed to close the ulcer
Time frame: [Time Frame: 1-12 weeks]
Quality of life using the Wound quality of Life questionare wQOL
Time frame: [Time Frame: 1-12 weeks]
Determine improvement in Quality of Life - Forgotten Wound Score FWS
Time frame: [Time Frame: 1-12 weeks]
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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Venous Leg Ulcer (VLU) and Venous Leg Ulcers, 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 14 inclusion and 24 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Barkley Booker (888-960-1343 ext. 1019, bbooker@serenagroups.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of target ulcers achieving complete wound closure (time frame: [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 24 Jan 2025.