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Acellular Matrix

Dermacell for Foot Ulcer

Phase 2 & 3
Waitlist Available
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-infected deep wounds (Grade 2 Wagner Ulcer Classification)
18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up an average of 16 weeks.
Awards & highlights

Study Summary

This trial is a prospective, randomized, controlled, single-center trial. A total of 50 subjects will be randomized in a 1:1 ratio to either DermaCELL or Integra.

Eligible Conditions
  • Foot Ulcer
  • Diabetic Foot Ulcer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~an average of 16 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and an average of 16 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
Lower Extremity Skin Perfusion at 16 Weeks
Percentage of Wound Granulation at 16 Weeks
Wound Area at 16 Weeks
+1 more
Secondary outcome measures
Number of Participants With Frailty
Number of Participants With Graft Re-application to One Wound at 16 Weeks
Number of Participants With Wound Complications at 16 Weeks
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DermacellExperimental Treatment1 Intervention
Subject will receive treatment for one non-healing deep diabetic foot ulcer using one Dermacell acellular matrix. Subject will be followed up to 16 weeks post treatment, or until wound has closed, whichever comes first.
Group II: IntegraActive Control1 Intervention
Subject will receive treatment for one non-healing deep diabetic foot ulcer using one Integra bilayer cross-linked matrix. Subject will be followed up to 16 weeks post treatment, or until wound has closed, whichever comes first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dermacell
2018
Completed Phase 3
~100

Find a Location

Who is running the clinical trial?

LifeNet HeathUNKNOWN
Baylor College of MedicineLead Sponsor
997 Previous Clinical Trials
6,001,855 Total Patients Enrolled
5 Trials studying Foot Ulcer
334 Patients Enrolled for Foot Ulcer
LifeNet HealthIndustry Sponsor
14 Previous Clinical Trials
1,258 Total Patients Enrolled
3 Trials studying Foot Ulcer
383 Patients Enrolled for Foot Ulcer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~5 spots leftby Mar 2025