NCT07653165

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Apr 2026Dec 2026

First Submitted

Initial submission to the registry

February 20, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

9 months

First QC Date

February 20, 2026

Last Update Submit

June 14, 2026

Conditions

Chronic Lower Leg UlcerDiabetic Lower Extremity UlcersPressure InjuriesTraumatic Wounds and InjuriesSurgical Wounds

Keywords

Chronic WoundsDebridementNegative Pressure Wound TherapyNPWTAcute WoundsDiabetic UlcersVenous UlcersWounds

Outcome Measures

Primary Outcomes (1)

  • Percent Area Reduction of Wound Size

    PAR reduction

    28 days

Secondary Outcomes (2)

  • "Graft Ready State"

    Within 28 days

  • Number of Negative Pressure Dressing Applications

    28 days

Study Arms (1)

Treatment Arm

OTHER

Hydroprep and Negative pressure therapy arm

Device: Motion NPWT

Interventions

Motion NPWTDEVICE

Negative Pressure application

Treatment Arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Active infection or previous tissue grafting.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Boca Center for Wound Healing

Coconut Creek, Florida, 33073, United States

Location

Related Links

MeSH Terms

Conditions

Pressure UlcerWounds and InjuriesSurgical WoundVaricose Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue DiseasesVaricose VeinsVascular DiseasesCardiovascular DiseasesLeg Ulcer

Study Officials

  • Eric J Lullove, DPM

    West Boca Center for Wound Healing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2026

First Posted

June 17, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
At conclusion of study.
Access Criteria
Only the PI and Site investigator(s) and affiliated Study-related persons cleared to view materials.

Locations

US(1)