MedTrace Logo

A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot

NCT04564443 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2024-11-21

No results posted yet for this study

Summary

The purpose of this clinical investigation is to assess performance of the Medaxis Debritom+™ and to collect subject outcome data in the treatment of diabetic foot ulcers (DFU) vs Standard sharp debridement.

Conditions

  • Diabetic Foot Ulcer
  • Diabetic Foot

Interventions

OTHER

Medaxis Debritom+

Advanced micro fluid jet therapy to clean and stimulate wound

OTHER

Sharp Surgical Debridement

Scalpel or Curette to clean and debride wound

OTHER

Additional Outer Dressing Application

Application of moisture retentive dressing, and a multi layer compression dressing

OTHER

Offloading

Patient will be offloaded in a diabetic camboot after treatment, or total contact cast if patient cannot be fit with diabetic offloading boot

OTHER

Fibracol Wound Dressing

Application of a collagen alginate dressing

Sponsors & Collaborators

  • Professional Education and Research Institute

    collaborator OTHER

  • Medaxis, LLC

    lead INDUSTRY

Principal Investigators

  • Robert Galiano, MD · Northwestern University School of Medicine

  • David Armstrong, DPM, MD, PhD · University of Southern California; Keck School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-11
Primary Completion
2024-12-30
Completion
2024-12-30

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 NCT04564443 on ClinicalTrials.gov