Evaluating the Durability of Closure for Venous Leg Ulcers | NCT06697925

Studies
Evaluating the Durability of Closure for Venous Leg Ulcers

NCT06697925

Sponsor

Kerecis Ltd.

Status

Recruiting

Last Update Posted

Jan 24, 2025Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2025Estimated

Primary Completion Date

Oct 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Nov 18, 2024

First Submission Date that Met QC Criteria

Nov 18, 2024

First Posted Date

Nov 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2025

Last Update Posted Date

Jan 24, 2025Actual

Name	Class
Serena Group	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thor closure patients		Patients who achieved closure in during the THOR clinical trial

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	12-month follow-up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who achieved closure in during the THOR clinical trial

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bennett Rogers	Contact	888-960-1343	1008	brogers@serenagroups.com
Thomas Serena, MD	Contact	814-688-4000		tserena@serenagroups.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Serena Group	Recruiting	Monroeville	Pennsylvania	15146	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014647	Varicose Ulcer

Ancestor Terms

ID	Term
D014648	Varicose Veins
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D007871	Leg Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided