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Enrolling by invitation NCT07653165

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

No phase Interventional Chronic Lower Leg Ulcer Diabetic Lower Extremity Ulcers Pressure Injuries Traumatic Wounds and Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Motion NPWT.
Who it may be relevant to
Registry conditions: Chronic Lower Leg Ulcer, Diabetic Lower Extremity Ulcers, Pressure Injuries, Traumatic Wounds and Injuries. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

  • Device Motion NPWT
    Negative Pressure application

Primary outcome measures

  • Percent Area Reduction of Wound Size [Time frame: 28 days]
Secondary outcome measures (2)
  • "Graft Ready State" [Time frame: Within 28 days]
  • Number of Negative Pressure Dressing Applications [Time frame: 28 days]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Active infection or previous tissue grafting.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • West Boca Center for Wound Healing — Coconut Creek

Identifiers

NCT: NCT07653165 · HydroPrep-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗