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Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center

NCT04920253 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-11-21

No results posted yet for this study

Summary

Prospective, single-blinded, single-center, parallel group, randomized controlled trial (RCT) to assess rate and frequency of wound healing and associated financial savings, when using Medaxis debritom+ versus standard of care as a choice of debridement method, where both arms follow normal wound care practice in use of advanced wound care treatments.

Conditions

  • Diabetic Foot Ulcer
  • Venous Leg Ulcer
  • Surgical Wound Dehiscence
  • Traumatic Wounds

Interventions

DEVICE

Study Device Debridement

debritom+ water jet debridement

DEVICE

SOC Debridement

Sharp Scalpel

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Medaxis, LLC

    lead INDUSTRY

Principal Investigators

  • Melvin B Price, DPM · MCR Health Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-29
Primary Completion
2025-06-30
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 NCT04920253 on ClinicalTrials.gov