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Effect of Meso Wound Matrix in the Treatment of DFUs

NCT04182451 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-04-26

No results posted yet for this study

Summary

This is a prospective trial designed to evaluate the use of Meso Wound Matrix (DSM Biomedical, Exton, PA) in Wagner grade 1 and 2 DFUs.

Conditions

  • Diabetic Foot Ulcers (DFUs)

Interventions

DEVICE

Meso Wound Matrix

Subjects who meet eligibility criteria will receive standard of care and Meso Wound Matrix. The standard of care therapy in this study is offloading of the DFU, appropriate sharp or surgical debridement, and aggressive infection management with the use of appropriate dressings. Total contact casting or fixed ankle walker will be used for off-loading. Wound Matrix is an acellular scaffold to reinforce and repair soft tissue defects. Subjects may receive up to eight applications of Meso Wound Matrix. Subjects whose study ulcer does not heal after eight applications will receive only SOC treatment for 4 additional weeks.

Sponsors & Collaborators

  • DSM Biomedical, Inc.

    collaborator UNKNOWN

  • SerenaGroup, Inc.

    lead NETWORK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-05
Primary Completion
2022-05-17
Completion
2023-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04182451 on ClinicalTrials.gov