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Fish Skin Graft for Venous Leg Ulcers (THOR Trial)
Phase 4
Recruiting
Research Sponsored by Kerecis Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
1. Subjects must be at least 18 years of age or older.
3. No visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up [time frame: 1-12 weeks]
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial aims to compare the effectiveness of using Intact Fish Skin Graft in addition to standard care versus standard care alone in helping venous leg ulcers heal completely over a 12-week period.
Who is the study for?
This trial is for adults over 18 with nonhealing venous leg ulcers present for at least 4 weeks, but not treated with high-level compression for more than a year. The ulcer must be between 1 and 25 cm2 post-debridement. Participants need adequate blood flow as indicated by specific tests (ABI, TBI, TCOM, PVR). Those with multiple ulcers can join if the largest one meets these conditions.
What is being tested?
The study aims to see if adding Intact Fish Skin Graft (IFSG) to standard wound care helps heal tough venous leg ulcers better than just standard care alone. Patients are split into two groups: one receives IFSG/SOC and the other only SOC, and their healing progress is compared over a period of 12 weeks.
What are the potential side effects?
Potential side effects were not provided in the given information. Generally, side effects from skin grafts may include infection at the graft or donor site, scarring, and rejection of the graft.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My wound has not visibly improved or shrunk by 40% in the last month.
Select...
My ulcer is between 1 cm2 and 25 cm2 after cleaning.
Select...
I have at least two ulcers, 2 cm apart after cleaning.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ [time frame: 1-12 weeks]
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~[time frame: 1-12 weeks]
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The percentage of target ulcers achieving complete wound closure
Secondary study objectives
Adverse Events
Change in pain in target ulcer
Determine improvement in Quality of Life - Forgotten Wound Score FWS
+4 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intact Fish Skin Graft (IFSG) + Standard of CareExperimental Treatment1 Intervention
Up to 12 visits with Intact Fish Skin Graft (IFSG) + Standard of Care.
Group II: Standard of CareActive Control1 Intervention
Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading.
Find a Location
Who is running the clinical trial?
Kerecis Ltd.Lead Sponsor
13 Previous Clinical Trials
2,077 Total Patients Enrolled
Serena GroupUNKNOWN
4 Previous Clinical Trials
540 Total Patients Enrolled