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Biological

Dual Layer Amniotic Membrane (DLAM) + SOC for Foot Ulcer

Phase 4

Recruiting

Led By Thomas E Serena, MD,FACS

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 tv-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or final visit

Awards & highlights

Study Summary

This trial is testing whether a new treatment for diabetic foot ulcers (using a dual layer amniotic membrane) is better than the current standard of care. The trial will last for 12 months and will involve subjects from multiple centers.

Eligible Conditions

Chronic Diabetic Foot Ulcers

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ tv-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or final visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~tv-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or final visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and tv-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or final visit for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Complete Wound Closure

Secondary outcome measures

Adverse Events

Changes in bacterial Load

Pain Scale (The Pain, Enjoyment of Life and General Activity Scale). 0 = no pain , 10 = pain as bad as you can imagine

+2 more

Trial Design

2Treatment groups

Active Control

Group I: Dual Layer Amniotic Membrane (DLAM) + SOCActive Control1 Intervention

DLAM (Up to 10 weekly DLAM applications) + Standard of Care (sharp debridement, offloading, and proper moisture balance).

Group II: Standard of CareActive Control1 Intervention

Standard of Care: sharp debridement, offloading, and proper moisture balance.

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

1,688 Total Patients Enrolled

7 Trials studying Foot Ulcer

329 Patients Enrolled for Foot Ulcer

Tides MedicalIndustry Sponsor

1 Previous Clinical Trials

134 Total Patients Enrolled

1 Trials studying Foot Ulcer

134 Patients Enrolled for Foot Ulcer

Thomas E Serena, MD,FACSPrincipal InvestigatorSerena Group, Inc

3 Previous Clinical Trials

53 Total Patients Enrolled

1 Trials studying Foot Ulcer

Frequently Asked Questions

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

What is the geographic breadth of this research protocol?

"Martin Foot and Ankle in York, Titan Research in Phoenix, and New Hope Podiatry in Los Angeles are three of the 13 clinical trial sites offering this medical intervention. The other 10 locations can be found on clinicialtrials.gov."

Answered by AI

Is participation in this medical investigation still open?

"Affirmative. According to the information present on clinicaltrials.gov, recruitment for this study is currently ongoing. The trial was initially posted on September 1st 2020 and underwent its most recent update November 3rd 2022. 124 participants are required from 13 different sites in total."

Answered by AI

How many participants have signed up to take part in this research project?

"The study sponsor, Tides Medical, requires 124 patients that meet the standards for inclusion to commence this trial. Such individuals can be found at Martin Foot and Ankle in York, Arizona and Titan Research in Phoenix, California."

Answered by AI

Has the combination of Dual Layer Amniotic Membrane and Standard of Care been authorized by the FDA?

"With a score of 3, our company deems Dual Layer Amniotic Membrane (DLAM) + SOC to be safe due to Phase 4 status which implies approval from the relevant governing bodies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®)

2020. "Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04457752.