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A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers

NCT06453187 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-04-14

No results posted yet for this study

Summary

The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of hard-to-heal diabetic foot and venous leg ulcers.

Conditions

  • Diabetic Foot Ulcer
  • Venous Leg Ulcer

Interventions

DEVICE

Urinary Bladder Matrix (UBM) sheet device for Venous Leg Ulcers

Application of Urinary Bladder Matrix (UBM) sheet device, a porcine-derived extracellular matrix scaffold, and 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.

DEVICE

Urinary Bladder Matrix (UBM) sheet device for Diabetic Foot Ulcers

Application of Urinary Bladder Matrix (UBM) sheet device, a porcine-derived extracellular matrix scaffold, and 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.

DEVICE

AmnioExcel Plus for Venous Leg Ulcers

Application of AmnioExcel Plus, a tri-layer (amnion-chorion-amnion) dehydrated human placental membrane allograft, and 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.

DEVICE

AmnioExcel Plus for Diabetic Foot Ulcers

Application of AmnioExcel Plus, a tri-layer (amnion-chorion-amnion) dehydrated human placental membrane allograft, and 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.

PROCEDURE

Standard of Care

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.

Sponsors & Collaborators

  • SerenaGroup, Inc.

    collaborator NETWORK

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Tomas Serena, MD · SerenaGroup, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-18
Primary Completion
2026-12-31
Completion
2027-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06453187 on ClinicalTrials.gov