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Cellular Therapy
Amnio Products for Diabetic Foot Ulcers and Venous Leg Ulcers
Verified Trial
N/A
Recruiting
Research Sponsored by Stability Biologics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is your foot or leg ulcer between 1-20 cm2?
Has your foot or leg ulcer been present for at least a month but no longer than a year?
Must not have
Is your foot or leg ulcer infected or has it been infected recently?
Does your foot ulcer expose tendon or bone?
Timeline
Screening 2 weeks
Treatment 12 days
Follow Up 2 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is looking at different products and treatments for diabetic foot and venous leg ulcers to see if they work better than the standard treatment alone.
Who is the study for?
This trial is for individuals with nonhealing diabetic foot or venous leg ulcers that are larger than a dime but smaller than a bottle cap, present for at least one month but not more than a year. It's not suitable for those with infected ulcers or ulcers exposing tendon or bone.
What is being tested?
The study compares various treatments including cellular and matrix-like products (CAMPs) combined with standard care versus standard care alone in healing diabetic foot and venous leg ulcers across multiple centers.
What are the potential side effects?
Potential side effects may include local reactions like redness, pain at the treatment site, infection risks, allergic responses to the CAMP materials used, and possible systemic reactions depending on individual patient conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 2 weeks1 visit
Treatment ~ 12 days12 visits
Follow Up ~ 2 weeks1 visit
Screening ~ 2 weeks
Treatment ~ 12 days
Follow Up ~2 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Determine the between-arm difference
Secondary study objectives
Adverse Events
Change in pain in target ulcer
Determine improvement in Quality of Life - FWS and determine improvement in Quality of Life - wQOL
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
7Treatment groups
Experimental Treatment
Active Control
Group I: Amniocore Pro + - DFUExperimental Treatment1 Intervention
Dual layer, amnion/chorion membrane allograft.
Group II: AmnioCore Pro - VLUExperimental Treatment1 Intervention
Three layer, amnion/chorion/amnion membrane allograft.
Group III: AmnioCore - DFUExperimental Treatment1 Intervention
Dual layer, amniotic membrane allograft.
Group IV: Amnio Tri-Core - VLUExperimental Treatment1 Intervention
Three layer, amniotic membrane allograft.
Group V: Amnio Quad-Core - DFUExperimental Treatment1 Intervention
Four layer, amniotic membrane allograft.
Group VI: Standard of Care-DFUActive Control1 Intervention
Debridement, reduction of bacterial burden, and proper moisture balance using dressings provided by SerenaGroup. Off-loading using the off-loading boot or total contact cast (TCC) provided by SerenaGroup.
Group VII: Standard of Care-VLUActive Control1 Intervention
Debridement, reduction of bacterial burden, and proper moisture balance using dressings provided by SerenaGroup. Compression using multilayer compression wraps provided by SerenaGroup.
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Stability BiologicsLead Sponsor
SerenaGroup, Inc.NETWORK
30 Previous Clinical Trials
3,240 Total Patients Enrolled
16 Trials studying Foot Ulcer
1,937 Patients Enrolled for Foot Ulcer