Use of Hydroprep Wound Therapy With Motion Negative Pressure Therapy for Treatment of Chronic Lower Extremity Wounds

June 14, 2026 updated by: West Boca Center for Wound Healing

A Prospective, Open-Label, Single-Arm Clinical Trial Evaluating the Efficacy of Hydroprep Wound Therapy Followed by Motion Negative Pressure Wound Therapy in the Treatment of Chronic Lower Extremity Wounds

Use of a motorized waterjet to debride wounds to improve healing outcomes.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Hydroprep is a powered waterjet of saline solution used to debride, remove and surgically clean an open wound of any type to improve its ability to heal. The device may also be used to prepare a wound prior to application of a tissue product or a skin graft from the patient. Between treatments, the use of a negative pressure suction portable unit will be used to improve the healing outcome of the wound.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Coconut Creek, Florida, United States, 33073
        • West Boca Center for Wound Healing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Any chronic lower extremity wound greater than 30 days duration.

Exclusion Criteria:

  • Active infection or previous tissue grafting.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Treatment Arm
Hydroprep and Negative pressure therapy arm
Device: Motion NPWT
Negative Pressure application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Area Reduction of Wound Size
Time Frame: 28 days
PAR reduction
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"Graft Ready State"
Time Frame: Within 28 days
Time to achieve target wound to a Graft-ready status
Within 28 days
Number of Negative Pressure Dressing Applications
Time Frame: 28 days
Actual number of times the NPWT dressing was changed prior to discontinuation
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Boca Center for Wound Healing

Investigators

  • Principal Investigator: Eric J Lullove, DPM, West Boca Center for Wound Healing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

June 14, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 14, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HydroPrep-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Demographic only: gender, age, race, medical problems, medications and study related treatments and measurements.

IPD Sharing Time Frame

At conclusion of study.

IPD Sharing Access Criteria

Only the PI and Site investigator(s) and affiliated Study-related persons cleared to view materials.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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