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Cellular Therapy

Amnio Products for Foot and Leg Ulcers

Verified Trial

N/A

Waitlist Available

Research Sponsored by Stability Biologics

Eligibility Criteria Checklist

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

Must have

Has your foot ulcer been present for at least a month but no longer than a year?

Is your foot ulcer between 1-5cm2? (ie - is it bigger than a dime but smaller than a bottle cap?)

Must not have

Does your foot ulcer expose tendon or bone?

Is your foot ulcer infected or has it been infected recently?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-14 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 below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-14 weeks for reporting.

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 more

Awards & 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.

0 / 4Eligibility criteria met