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Multiple Treatments for Foot and Leg Ulcers

N/A
Waitlist Available
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

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.
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My foot ulcer is complicated by a bone infection.
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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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of complete wound closure for target ulcer
Secondary outcome measures
Adverse Events
Changes to pain associated with the target ulcer
Determine improvement in Quality of Life
+2 more

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
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 IV: Diabetic Foot 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 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

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Who is running the clinical trial?

Integra LifeSciences CorporationLead Sponsor
85 Previous Clinical Trials
9,479 Total Patients Enrolled
19 Trials studying Foot Ulcer
2,214 Patients Enrolled for Foot Ulcer
SerenaGroup, Inc.NETWORK
24 Previous Clinical Trials
2,068 Total Patients Enrolled
10 Trials studying Foot Ulcer
765 Patients Enrolled for Foot Ulcer
Tomas Serena, MDPrincipal InvestigatorSerenaGroup, Inc.
~233 spots leftby Jun 2026
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