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Cellular Therapy

Cellular, Acellular, and Matrix-like Products for Diabetic Foot and Venous Leg Ulcers

Monroeville, PA
Phase 4
Recruiting
Research Sponsored by Tiger Biosciences, LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
(DFU) Subjects must be at least 21 years of age or older
(DFU) Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus
Must not have
(DFU) Subjects' target ulcer not secondary to diabetes
(DFU) Wound with active or latent infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-12 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial will compare different types of products along with standard care to see which is more effective in treating nonhealing diabetic foot and venous leg ulcers.

See full description
Who is the study for?
Adults over 21 with nonhealing diabetic foot ulcers (DFU) or venous leg ulcers (VLU) that have persisted for 4-52 weeks. DFUs must be on the foot and grade Wagner 1 or 2, VLUs should show less than a 40% size reduction in the last month. Participants need adequate blood flow to the limb and can't be pregnant, have severe diabetes complications, infections at ulcer sites, recent participation in other trials, or conditions affecting wound healing.Check my eligibility
What is being tested?
The trial is testing ACApatch™ and caregraFT™ alongside standard treatments against standard treatment alone for chronic ulcers. It's a multicenter study where participants are randomly assigned to receive either one of these products plus usual care or just the usual care to see which approach helps heal ulcers better.See study design
What are the potential side effects?
Potential side effects may include local reactions at application sites like redness, swelling, pain; infection risk; allergic responses; and possible systemic effects depending on how the body reacts to CAMPs. The exact side effects will depend on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 years old or older.
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I have been diagnosed with type 1 or type 2 diabetes.
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My ulcer is between 1.0 cm2 and 20.0 cm2 after cleaning.
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My foot ulcer is mostly located below my ankle.
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My foot ulcer is classified as mild or moderate.
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My affected limb has good blood flow.
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I am 21 years old or older.
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My wound has not reduced in size by 40% in the last 4 weeks.
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My affected limb has good blood flow.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My foot ulcer is not caused by diabetes.
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My wound is infected or was recently infected.
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My foot ulcer exposes tendon or bone.
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My foot ulcer is complicated by a bone infection.
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I am taking medication that affects my immune system or wound healing.
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I have Charcot foot affecting my ulcer treatment.
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I have severe kidney disease and need dialysis.
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My ulcer is infected or surrounded by cellulitis, needing antibiotics.
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My ulcer is complicated by a bone infection.
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My HbA1c level is 12% or higher.
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I am not pregnant nor planning to become pregnant in the next 6 months.
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I need dialysis for my end-stage kidney disease.
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My wound is infected or might be infected.
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I have a condition that increases my risk of surgery complications.
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My foot ulcer is infected or surrounded by cellulitis, needing antibiotics.
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My ulcer exposes tendon or bone.
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I am not pregnant nor planning to become pregnant in the next 6 months.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-12 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
The between-arm difference in subjects that complete wound closure
Secondary study objectives
Adverse Events
Difference between CAMP plus SOC versus SOC alone in subjects that complete wound closure
Percent Area Reduction
+1 more
Other study objectives
Age
Functional Ambulatory Category Scale
Wound Quality of Life

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: VLU CAMP 2 + SOC = caregraFT™ + SOCExperimental Treatment1 Intervention
caregraFT™ is a human amniotic membrane tissue allografts derived from human placental tissue.
Group II: VLU CAMP 1 + SOC = ACApatch™ + SOCExperimental Treatment1 Intervention
ACApatch™ is a human amniotic membrane tissue allografts derived from human placental tissue.
Group III: DFU CAMP 2 + SOC = caregraFT™ + SOCExperimental Treatment1 Intervention
caregraFT™ is a human amniotic membrane tissue allografts derived from human placental tissue.
Group IV: DFU CAMP 1 + SOC = ACApatch™ + SOCExperimental Treatment1 Intervention
ACApatch™ is a human amniotic membrane tissue allografts derived from human placental tissue.
Group V: DFU Standard of CareActive Control1 Intervention
Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading.
Group VI: VLU Standard of CareActive Control1 Intervention
Standard of care will be cleaning, debridement, and ulcer moisture balance.

Find a Location

Closest Location:Serena Group· Monroeville, PA

Who is running the clinical trial?

SerenaGroup, Inc.NETWORK
31 Previous Clinical Trials
3,605 Total Patients Enrolled
17 Trials studying Foot Ulcer
2,302 Patients Enrolled for Foot Ulcer
Tiger Biosciences, LLC.Lead Sponsor
7 Previous Clinical Trials
7,645 Total Patients Enrolled
~227 spots leftby Dec 2027
Unbiased ResultsWe believe in providing patients with all the options.
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