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Extracellular Matrix Therapy

InnovaMatrix AC porcine placental ECM therapy for Foot Ulcer

N/A

Recruiting

Led By Thomas E Serena, MD

Research Sponsored by SerenaGroup, Inc.

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 12 weeks

Awards & highlights

Study Summary

This trial will study the safety and effectiveness of a weekly application of sterilized, porcine placental ECM as a treatment for chronic, non-healing diabetic foot ulcers.

Eligible Conditions

Foot Ulcer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks 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 area using digital image

Secondary outcome measures

Adverse events

Percentage area reduction

Wound Closure

Other outcome measures

Bacterial burden assessment

Presence of protease levels

Trial Design

1Treatment groups

Experimental Treatment

Group I: InnovaMatrix AC porcine placental ECM therapyExperimental Treatment1 Intervention

Eligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and offloading

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

SerenaGroup, Inc.Lead Sponsor

21 Previous Clinical Trials

1,782 Total Patients Enrolled

7 Trials studying Foot Ulcer

423 Patients Enrolled for Foot Ulcer

Thomas E Serena, MDPrincipal InvestigatorSerenaGroup, Inc.

3 Previous Clinical Trials

206 Total Patients Enrolled

Frequently Asked Questions

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

Are there currently openings for volunteers in this clinical research?

"According to the clinicaltrials.gov webpage, this trial has been actively recruiting since October 6th 2022 and was last updated on January 6th 2023."

Answered by AI

How many participants is this experiment accommodating?

"Affirmative, the information hosted on clinicaltrials.gov indicates that this medical experiment is actively recruiting participants. This trial was first made available to the public on October 6th 2022 and has been modified most recently in January of 2023. 30 people are being sought from 5 different locations for this endeavor."

Answered by AI

In what locations has this trial been implemented?

"The Serena Group Buffalo Research Center in Buffalo, New york; the SerenaGroup Monroeville in Monroeville, Pennsylvania; and the SerenaGroup Austin Research Centre in Austin, Texas are all hosting this clinical trial. An additional 5 research centres will be included as well."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

STERILIZED, PORCINE PLACENTAL TISSUE IN THE TREATMENT OF CHRONIC DIABETIC FOOT ULCERS

2022. "STERILIZED, PORCINE PLACENTAL TISSUE IN THE TREATMENT OF CHRONIC DIABETIC FOOT ULCERS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05687656.