ClinicalTrials.gg
Enrolling by invitationNCT07653165Updated Jun 17, 2026

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

An interventional study of Motion NPWT in Chronic Lower Leg Ulcer, Diabetic Lower Extremity Ulcers and Pressure Injuries, sponsored by West Boca Center for Wound Healing. Enrolling by invitation at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-06-17.

Sponsored by West Boca Center for Wound Healing · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Chronic Lower Leg Ulcer
  • Diabetic Lower Extremity Ulcers
  • Pressure Injuries
  • Traumatic Wounds and Injuries
  • Surgical Wounds

Keywords

  • Chronic Wounds
  • Debridement
  • Negative Pressure Wound Therapy
  • NPWT
  • Acute Wounds
  • Diabetic Ulcers
  • Venous Ulcers
  • Wounds
03

In context

Pressure Ulcer

545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.

This study's planned enrollment of 50 is below the median of 70 across 405 interventional studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

This is the only study on the registry with West Boca Center for Wound Healing as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Active infection or previous tissue grafting.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Other
    Treatment Arm

    Hydroprep and Negative pressure therapy arm

    Device: Motion NPWT

Interventions

  • DeviceMotion NPWT

    Negative Pressure application

06

What researchers measure

Primary outcomes

  1. Percent Area Reduction of Wound Size

    PAR reduction

    Time frame: 28 days

Secondary outcomes

  1. "Graft Ready State"

    Time to achieve target wound to a Graft-ready status

    Time frame: Within 28 days

  2. Number of Negative Pressure Dressing Applications

    Actual number of times the NPWT dressing was changed prior to discontinuation

    Time frame: 28 days

07

Study locations

1 site
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Demographic only: gender, age, race, medical problems, medications and study related treatments and measurements.

Supporting information: Study protocol, Informed consent form, Clinical study report

Time frame: At conclusion of study.

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

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07653165
Lead sponsor
West Boca Center for Wound Healing
Responsible party
Sponsor
First posted
Jun 17, 2026
Start date
Apr 15, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 17, 2026

Study contacts

Eric J Lullove, DPM
principal investigator · West Boca Center for Wound Healing

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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