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Sterilised, Porcine Placental Tissue in the Treatment of Chronic Diabetic Foot Ulcers

NCT05687656 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-05-31

No results posted yet for this study

Summary

A Prospective, Non-Randomized, Multi-Center Observational Study

To determine the safety and effectiveness of InnovaMatrix AC porcine placental ECM therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs)

Eligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and offloading

Conditions

  • Diabetic Foot Ulcer

Interventions

DEVICE

InnovaMatrix AC porcine placental ECM therapy

All eligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care moist wound therapy and offloading

Sponsors & Collaborators

  • ConvaTec Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas E Serena, MD · SerenaGroup, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-06
Primary Completion
2025-12-31
Completion
2025-12-31
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 NCT05687656 on ClinicalTrials.gov