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Cellular and Matrix Products for Diabetic Foot and Venous Leg Ulcers (CAMPLIFE Trial)

Phase 4

Recruiting

Led By Tomas Serena, MD

Research Sponsored by Cellution Biologics

Eligibility Criteria Checklist

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

Must have

Subjects must be at least 18 years of age or older

Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus

Must not have

A subject with end stage renal disease requiring dialysis is excluded

If the target ulcer is infected or if there is cellulitis in the surrounding skin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-12 weeks

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

"This trial aims to see if using a combination of different cellular, acellular, and matrix-like products along with the standard treatment works better than standard treatment alone in healing diabetic foot and venous leg ul

Who is the study for?

This trial is for adults over 18 with type 1 or 2 diabetes who have nonhealing foot or leg ulcers. The ulcers should be of a specific size, not involve exposed tendon or bone, and have persisted for at least 4 weeks despite standard care. Participants must also meet certain blood flow criteria to ensure proper wound healing.

What is being tested?

The study is testing the effectiveness of multiple CAMPs (Cellular, Acellular and Matrix-Like Products) in combination with Standard of Care versus Standard of Care alone in fully closing diabetic foot and venous leg ulcers.

What are the potential side effects?

While the side effects are not explicitly listed here, treatments involving cellular products can sometimes include infection risk at the site, allergic reactions, pain during application or changes in skin coloration around the treated area.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 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 0.7 and 5.0 cm2 after cleaning.

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My foot ulcer is mostly below my ankle.

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My foot ulcer is deep but does not show tendon or bone.

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My affected limb has good blood flow.

Exclusion Criteria

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

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I do not require dialysis for end-stage kidney disease.

Select...

My target ulcer is infected or the skin around it has cellulitis.

Select...

My wound is complicated by a bone infection.

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I have not had a foot amputation that affects my ability to relieve pressure on a foot ulcer.

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My ulcer is caused by diabetes.

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I do not have any infections requiring antibiotics.

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I am not on high-dose steroids or chemotherapy drugs that suppress my immune system.

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I do not have an active or inactive Charcot foot that affects wound healing.

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I have not had hyperbaric oxygen therapy or any CAMP treatments in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-12 weeks

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

Percentage of ulcers with complete wound closure

Secondary study objectives

Changes to pain associated with the target ulcer

Determine changes in Quality of Life

Incidence of Adverse events

+2 more

Other study objectives

Changes in ambulation

Changing in bacterial load

Awards & Highlights

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.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: AIC for VLUsExperimental Treatment2 Interventions

Participants with a venous leg ulcer (VLU) will receive treatment with an Amnion-Intermediate-Chorion sheet, a dehydrated multilayer human placental product derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Group II: AIC for DFUsExperimental Treatment2 Interventions

Participants with a diabetic foot ulcer (DFU) will receive treatment with an Amnion-Intermediate-Chorion sheet product, a dehydrated multilayer human placental tissue derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Group III: ACA for VLUsExperimental Treatment2 Interventions

Participants with a venous leg ulcer (VLU) will receive treatment with an Amnion-Chorion-Amnion allograft sheet, a dehydrated trilayer human placental product derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Group IV: ACA for DFUsExperimental Treatment2 Interventions

Participants with a diabetic foot ulcer (DFU) will receive treatment with an Amnion-Chorion-Amnion sheet allograft product, a dehydrated trilayer human placental tissue derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Group V: Standard of CareActive Control1 Intervention

Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard of Care

2017

Completed Phase 4

~4420

0 / 15Eligibility criteria met