Venous Leg, Venous Leg Ulcer, Venous Leg Ulcer (VLU), Venous Ulcer, VLU
Conditions
Brief 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.
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.
Interventions
None listed
Sponsors
Serena Group
Kerecis Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Subjects must have participated in the THOR trial and achieved complete closure by the 12-week endpoint.
Exclusion criteria
* 1\. Subjects who did not participate in the THOR trial. 2. Subjects who participated in the THOR trial and did not achieve complete closure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Durability of closure | 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. |
Countries
United States
Contacts
Primary ContactBennett Rogers
Backup ContactThomas Serena, MD
Outcome results
None listed