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Multiple Treatments for Foot and Leg Ulcers

N/A

Recruiting

Led By Tomas Serena, MD

Research Sponsored by Integra LifeSciences Corporation

Eligibility Criteria Checklist

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

Must have

Target ulcer located on the foot with at least 50% of the ulcer below the malleolus

Target ulcer full thickness without exposed bone

Must not have

Receiving immunosuppressants or medications interfering with wound healing

Target ulcer not secondary to diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-14 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if using multiple types of products along with standard treatment helps heal diabetic foot and venous leg ulcers better than standard treatment alone.

Who is the study for?

This trial is for adults over 18 with type 1 or 2 diabetes who have had a foot or leg ulcer for 4-52 weeks. The ulcer must be full thickness, not expose bone, and measure between 1.0 cm² and 25.0 cm² post-debridement. Participants need good blood flow in the limb and must agree to offload the affected area and attend weekly visits. Exclusions include severe uncontrolled diabetes (HbA1c ≥12%), recent use of certain medications, malnutrition, pregnancy, other clinical trials within the last month, or conditions affecting wound healing.

What is being tested?

The study compares different treatments for diabetic foot and venous leg ulcers: Standard of Care alone versus Standard of Care plus either Urinary Bladder Matrix (UBM) sheet device or AmnioExcel Plus. It aims to see which method best achieves complete closure of these chronic wounds.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include typical wound treatment complications such as infection at the site of application, allergic reactions to materials used in UBM sheets or AmnioExcel Plus products, irritation around the wound area, or no improvement in healing.

Eligibility Criteria

Inclusion Criteria

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

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My foot ulcer is mostly located below my ankle.

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My ulcer is deep but does not show any exposed bone.

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My foot ulcer has been offloaded for at least 2 weeks before joining.

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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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Blood flow in my affected limb is confirmed to be good.

Exclusion Criteria

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

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I am taking medication that affects my immune system or wound healing.

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My ulcer is not caused by diabetes.

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My ulcer exposes tendon or bone.

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My ulcer has shrunk by more than 20% in the last 2 weeks.

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My ulcer was treated with special oxygen therapy or CAMP within the last month.

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I am currently taking hydroxyurea.

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I am on dialysis for end-stage kidney disease.

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My wound or the skin around it is infected.

Select...

My foot ulcer is complicated by a bone infection.

Select...

I have a deformity from a partial amputation that affects my ability to walk or stand properly.

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I am currently on antibiotics for an infection.

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I have a condition called Charcot foot that affects my ability to walk.

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

Percentage of complete wound closure for target ulcer

Secondary study objectives

Adverse Events

Changes to pain associated with the target ulcer

Determine improvement in Quality of Life

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Venous Leg Ulcers with a Urinary Bladder Matrix (UBM) sheet deviceExperimental Treatment2 Interventions

Participants will receive treatment with Urinary Bladder Matrix (UBM) sheet device, a porcine-derived extracellular matrix scaffold, 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: Venous Leg Ulcers with AmnioExcel PlusExperimental Treatment2 Interventions

Participants will receive treatment with AmnioExcel Plus, a tri-layer (amnion-chorion-amnion) dehydrated human placental membrane allograft, 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: Diabetic Foot Ulcers with Urinary Bladder Matrix (UBM) sheet deviceExperimental Treatment2 Interventions

Group IV: Diabetic Foot Ulcers with AmnioExcel PlusExperimental Treatment2 Interventions

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 / 18Eligibility criteria met