Chronic Lower Leg UlcerNCT07653165
Use of Hydroprep Wound Therapy With Motion Negative Pressure Therapy for Treatment of Chronic Lower Extremity Wounds
A study testing Motion NPWT in people with Chronic Lower Leg Ulcer and Diabetic Lower Extremity Ulcers, run by West Boca Center for Wound Healing at 1 site in United States.
Trial summary
Use of a motorized waterjet to debride wounds to improve healing outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Lower Leg Ulcer, Diabetic Lower Extremity Ulcers, Pressure Injuries
- What is being tested?
- Motion NPWT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any chronic lower extremity wound greater than 30 days duration.
Who cannot join
- Active infection or previous tissue grafting.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
West Boca Center for Wound Healing
Coconut Creek, Florida, 33073
About this study
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
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.
- Conditions
- Chronic Lower Leg Ulcer, Diabetic Lower Extremity Ulcers, Pressure Injuries, Traumatic Wounds and Injuries, Surgical Wounds
- Being tested
- Motion NPWT
- Keywords
- Chronic Wounds, Debridement, Negative Pressure Wound Therapy, NPWT, Acute Wounds, Diabetic Ulcers, Venous Ulcers, Wounds
- Medical subject headings
- Pressure Ulcer, Wounds and Injuries, Surgical Wound, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motion NPWTDevice
Negative Pressure application
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Other | Hydroprep and Negative pressure therapy arm Receives: Device: Motion NPWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Area Reduction of Wound Size
PAR reduction
Measured: 28 days
Secondary outcomes (2)
"Graft Ready State"
Time to achieve target wound to a Graft-ready status
Measured: Within 28 days
Number of Negative Pressure Dressing Applications
Actual number of times the NPWT dressing was changed prior to discontinuation
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start15 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lower Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Boca Center for Wound Healing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric J Lullove, DPM, Principal investigator, West Boca Center for Wound Healing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653165
- Sponsor's protocol ID
- HydroPrep-01
- Status last verified
- Jun 2026
- First submitted
- 20 Feb 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Demographic only: gender, age, race, medical problems, medications and study related treatments and measurements.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07653165
- Acronym / sponsor ID
- HydroPrep-01
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- West Boca Center for Wound HealingUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Other | Device: Motion NPWTHydroprep and Negative pressure therapy arm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any chronic lower extremity wound greater than 30 days duration.
Key exclusion criteria (1 listed)
- Active infection or previous tissue grafting.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motion NPWTNegative Pressure application | Device | Treatment Arm |
Primary outcome
Percent Area Reduction of Wound Size
Time frame: 28 days
PAR reduction
2 secondary outcomes
"Graft Ready State"
Time frame: Within 28 days
Number of Negative Pressure Dressing Applications
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- MedAxis, LLCLink provided by the sponsor.
- MIMOSA Oxygen Thermography DeviceLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Demographic only: gender, age, race, medical problems, medications and study related treatments and measurements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric J Lullove, DPM principal investigator
West Boca Center for Wound Healing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motion NPWT in people with Chronic Lower Leg Ulcer and Diabetic Lower Extremity Ulcers, run by West Boca Center for Wound Healing at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Area Reduction of Wound Size (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.