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NCT06384183 Clinical Trial

Kerecis Real World Registry

Diabetic Foot Ulcer Clinical Trial

Official title:
Kerecis Real World Registry

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06384183
Other study ID # KS-1000
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2024
Est. completion date June 2027

Study information
Verified date April 2024
Source Kerecis Ltd.
Contact Anne Swearingen, DBA
Phone 703 287 8752
Email aswearingen@kerecis.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Multi-center, observational (i.e., non-interventional), open-label, real-world Registry on the Use of Kerecis Devices

Description:

This observational (i.e., non-interventional), post-market, real-world, Registry was designed to collect, analyze, and identify relevant safety and performance outcomes for "all comers" using Kerecis devices in routine medical practice within a wide variety of United States (US) medical practice settings. These clinical data will be used at Kerecis for many purposes, which include, but are not limited to, device safety and performance evaluation as part of routine patient care and post-market clinical follow-up data commitments to regulatory authorities around the world.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 600
Est. completion date June 2027
Est. primary completion date June 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Provided informed consent - Has at least one target wound treated with a Kerecis device according to physician medical judgement within one calendar month prior to the registry enrollment date Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Kerecis Fish Skin Graft
Patients already treated with a Kerecis device

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Kerecis Ltd.

Outcome
Type Measure Description Time frame Safety issue
Primary Fish Skin Graft Device Related failure Proportion of patients with Kerecis FSG device-related failure for any reason (e.g., resulting in non-absorption or device removal) 12 months
Primary Fish Skin Graft Device related allergy Proportion of patients with Kerecis FSG device-related allergy, hypersensitivity and/or autoimmune reaction (with or without documented auto-antibody development) 12 months
Primary Target Wound Infection Proportion of patients who develop target wound infection 12 months
Secondary Complete Wound Healing The Time in weeks to complete healing 12 months
Secondary Complete Wound Closure Proportion of participants who experience complete wound closure 12 months
See also
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