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Evaluating the Durability of Closure for Venous Leg Ulcers

NCT ID: NCT06697925

Last Updated: 2025-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-31

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Venous Leg Venous Leg Ulcer (VLU) Venous Leg Ulcer Venous Ulcer VLU

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Thor closure patients

Patients who achieved closure in during the THOR clinical trial

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Serena Group

OTHER

Sponsor Role collaborator

Kerecis Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Serena Group

Monroeville, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Bennett Rogers

Role: CONTACT

[email protected]
888-960-1343 ext. 1008

Thomas Serena, MD

Role: CONTACT

[email protected]
814-688-4000

Facility Contacts

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Laura Serena

Role: primary

[email protected]
412-212-0123

Other Identifiers

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KS-1020

Identifier Type: -

Identifier Source: org_study_id

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