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Fish Skin Graft

Intervention Group for Foot Ulcer

N/A

Waitlist Available

Led By Eric J Lullove, DPM

Research Sponsored by Kerecis Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12weeks

Awards & highlights

Study Summary

This trial is collecting patient outcome data on the KerecisTM Omega3 Wound, a commercially available product that is derived from minimal processing of Atlantic cod fish skin. The primary endpoint is the percentage of index ulcers healed at 12 weeks.

Eligible Conditions

Diabetic Foot Ulcers

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Wound Healing

Secondary outcome measures

PAR

Pain reduction: visual analogue scale (VAS)

Time to Heal

Other outcome measures

Histology assessment from biopsies

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Intervention GroupActive Control1 Intervention

Kerecis affixed with steri-strips, cover with gauze and change one per week .

Group II: Standard of Care GroupPlacebo Group1 Intervention

Fibracol Dressing covered with gauze and wrapped with kerlix and wrap. Change 3Xper week

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Who is running the clinical trial?

Kerecis Ltd.Lead Sponsor

10 Previous Clinical Trials

1,227 Total Patients Enrolled

2 Trials studying Foot Ulcer

440 Patients Enrolled for Foot Ulcer

Mary Regan, PhDStudy DirectorKerecis Ltd.

Eric J Lullove, DPMPrincipal InvestigatorEric J. Lullove DPM, PA

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment process for this investigation currently open to participants?

"The clinicaltrials.gov listing reveals that this study, which was posted on July 31st 2019 and last updated on July 4th 2022 is not currently looking for participants. However, there are 137 other medical trials actively enrolling patients at the moment."

Answered by AI

How widely is this research endeavor being conducted?

"Drs. Christopher Winters, Brock Liden and Allen Raphael are administering the trial out of their respective offices in Carmel, Circleville and Smyrna respectively alongside 5 ancillary medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Omega3 Wound Fish Skin Graft in the Treatment of DFUs

2019. "Omega3 Wound Fish Skin Graft in the Treatment of DFUs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04133493.