Venous Leg UlcersNPWTNCT02470806

Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy System (tNPWT)

A study testing PICO System and tNPWT System in people with Venous Leg Ulcers and Diabetic Foot Ulcers, run by Smith & Nephew, Inc. at 17 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to compare the clinical efficacy of two types of NPWT systems; the traditional negative pressure wound therapy (tNPWT) system and the single-use negative pressure wound therapy (PICO) system. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Venous Leg Ulcers, Diabetic Foot Ulcers
What is being tested?: PICO System and tNPWT System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 164 participants
Where: 17 sitesin 2 countries
Study dates: 2 Jul 2015to 14 Nov 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provide informed consent
Age ≥ 18 years and of either sex
Willing to comply with protocol instructions, including allowing all study assessments
Have a Venous Leg Ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 36.0 cm2
Target ulcer duration ≥ 4 weeks but ≤ 104 weeks (24 months)
Have a Diabetic Foot Ulcer (DFU) present on any part of the plantar or dorsum surface of the foot, with a surface area ≥ 0.5 cm2 and ≤ 10.0 cm2

Show all 9Show fewer

Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone
Target ulcer duration ≥ 4 weeks but ≤ 52 weeks (12 months)
Acceptable state of health and nutrition

Who cannot join

Therapy with another investigational agent within thirty (30) days of Screening, or during the study Ulcers which are deemed as highly exuding, per the Investigator's discretion.
Current diagnosis of osteomyelitis at the target wound location that is not currently receiving treatment [Documented history of resolved osteomyelitis is allowed].
Subjects with a VLU: Refusal of or inability to tolerate compression therapy.
Clinical evidence of target ulcer infection
Current systemic therapy with cytotoxic drugs.
Current therapy with chronic (> 10 days) oral corticosteroids.
Previous treatment with NPWT device or hyperbaric oxygen within 7 days of screening.
Malignancy in the target ulcer, or history of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers)

Trial locations and contacts

17 sites in 2 countries.

Country

City, postcode or hospital

17 sites in 2 countries

United States15 sites

Rubin Institute for Advanced Orthopedics
Baltimore, Maryland, 21215
ILD Consulting, Inc.
Carlsbad, California, 92009
NW University Feinberg School of Medicine
Chicago, Illinois, 60611
Acclaim Bone & Joint
Fort Worth, Texas, 76104
Valley Foot & Ankle Specialty Providers
Fresno, California, 93720
Advanced Foot & Ankle
Las Vegas, Nevada, 89119
The Sun Healthcare & Surgery Group
Martinez, California, 94553
Futuro Clinical Trials, LLC
McAllen, Texas, 78501
University of Miami
Miami, Florida, 33125
Ochsner Health System
New Orleans, Louisiana, 70121
Rosalind Franklin University of Med & Science
North Chicago, Illinois, 60064
Carilion Clinic
Roanoke, Virginia, 24013
Center for Clincial Research
San Francisco, California, 94115
Olive View - UCLA Medical Center
Sylmar, California, 91342
Center for Advanced Wound Care
Wyomissing, Pennsylvania, 19610

Other trials in United States

Canada2 sites

Centre podiatrique et soins des plaies
Boucherville, Quebec, J4B 5E4
The Mayer Institute
Hamilton, Ontario, L8R 2R3

Other trials in Canada

About this study

Official title: A Prospective, Randomized, Comparative Effectiveness Study of a Single-Use, Negative Pressure Wound Therapy System (PICO) Versus a Traditional Negative Pressure Wound Therapy System (tNPWT) in the Treatment of Lower Extremity Ulcers

Read the detailed description

The two types of NPWT systems include the tNPWT system that has successfully completed a coding verification request with CMS and has the following capabilities (e.g., range of negative pressure, connective tubing, canister, foam or gauze filler, and approved for home use), and a portable, canister-less, battery operated, disposable PICO system to see if there are any observed differences with regard to the clinical efficacy of the two devices.

Conditions: Venous Leg Ulcers, Diabetic Foot Ulcers
Being tested: PICO System, tNPWT System
Keywords: Venous leg ulcer, ulcer, venous stasis, compression, diabetic foot ulcers, dfu, vlu
Medical subject headings: Diabetic Foot, Varicose Ulcer, Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PICO SystemDevice
Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface
tNPWT SystemDevice
NPWT from -25 mmHg and up to -200 mmHg; intensity settings of either low, medium and high; delivery modes of continuous or intermittent. The pressure, intensity and delivery settings will be left to the Investigator's discretion at each study treatment visit.

Study groups in NCT02470806
Study group	Role	What they receive
PICO System	Experimental	Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface Receives: Device: PICO System
tNPWT System	Active comparator	Traditional NPWT (tNPWT) from -25 mmHg and up to -200 mmHg; intensity settings of either low, medium and high; delivery modes of continuous or intermittent. The pressure, intensity and delivery settings will be left to the Investigator's discretion at each study treatment visit. Receives: Device: tNPWT System

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Ulcer Area From Baseline to the End of the Treatment Period
Ulcer area was photographed in order to determine the measurements of the post-debridement ulcer area (cm^2 and total percentage [%]) using the ARANZ Silhouette wound imaging and measurement device.
Measured: Baseline through 12 weeks
Percentage Change in Ulcer Area From Baseline to the End of the Treatment Period
Ulcer area was photographed in order to determine the measurements of the postdebridement ulcer area (cm^2 and total percentage [%]) using the ARANZ Silhouette wound imaging and measurement device.
Measured: Baseline through 12 weeks

Secondary outcomes (3)

Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device.
Measured: Baseline through 12 weeks
Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device.
Measured: Baseline through 12 weeks
Percentage Change in Target Ulcer Depth and Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device.
Measured: Baseline through 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jul 201514 Nov 2017

First posted12 Jun 2015 (estimated)
Study start2 Jul 2015
Primary completion14 Nov 2017
Study completion14 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Venous Leg UlcersStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 164 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02470806
Sponsor's protocol ID: CE-052PIC
Acronym: NPWT
Status last verified: Apr 2020
First submitted: 10 Jun 2015
Last updated: 6 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Not yet recruiting
Subcutaneous Dexpanthenol Administration and Wound Epithelialization
Chronic Wounds, Diabetic Foot Ulcer
Not yet recruitingPhase 2
Controlled Study, Performed to Evaluate the Safety and Efficacy of EscharEx and Its Placebo (Gel Vehicle) Compared to Non-surgical Standard of Care in Participants With Venous Leg Ulcers (VLU)
Venus Leg Ulcers
RecruitingPhase 3
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
Venous Leg Ulcer (VLU)
Not yet recruitingPhase 1/2
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
Lower Extremity, Chronic Ulcers

All Venous Leg Ulcers trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Comparative Effectiveness Study of a Single-Use, Negative Pressure Wound Therapy System (PICO) Versus a Traditional Negative Pressure Wound Therapy System (tNPWT) in the Treatment of Lower Extremity Ulcers
ClinicalTrials.gov ID: NCT02470806
Acronym / sponsor ID: NPWT / CE-052PIC
Conditions: Venous Leg Ulcers, Diabetic Foot Ulcers
Keywords: Venous leg ulcer, ulcer, venous stasis, compression, diabetic foot ulcers, dfu, vlu
Study type: Interventional
Recruitment status: Completed
Enrolment: 164 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Study start: 2 Jul 2015 (actual)
Primary completion: 14 Nov 2017 (actual)
Study completion: 14 Nov 2017 (actual)
First posted: 12 Jun 2015 (estimated)
Results: Posted 6 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PICO System	Experimental	Device: PICO SystemNegative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface
tNPWT System	Active comparator	Device: tNPWT SystemTraditional NPWT (tNPWT) from -25 mmHg and up to -200 mmHg; intensity settings of either low, medium and high; delivery modes of continuous or intermittent. The pressure, intensity and delivery settings will be left to the Investigator's discretion at each study treatment visit.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Provide informed consent
Age ≥ 18 years and of either sex
Willing to comply with protocol instructions, including allowing all study assessments
Have a Venous Leg Ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 36.0 cm2
Target ulcer duration ≥ 4 weeks but ≤ 104 weeks (24 months)

Key exclusion criteria (8 listed)

Therapy with another investigational agent within thirty (30) days of Screening, or during the study Ulcers which are deemed as highly exuding, per the Investigator's discretion.
Current diagnosis of osteomyelitis at the target wound location that is not currently receiving treatment [Documented history of resolved osteomyelitis is allowed].
Subjects with a VLU: Refusal of or inability to tolerate compression therapy.
Clinical evidence of target ulcer infection
Current systemic therapy with cytotoxic drugs.

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
PICO SystemNegative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface	Device	PICO System
tNPWT SystemNPWT from -25 mmHg and up to -200 mmHg; intensity settings of either low, medium and high; delivery modes of continuous or intermittent. The pressure, intensity and delivery settings will be left to the Investigator's discretion at each study treatment visit.	Device	tNPWT System

Primary outcome

Change in Ulcer Area From Baseline to the End of the Treatment Period
Time frame: Baseline through 12 weeks
Ulcer area was photographed in order to determine the measurements of the post-debridement ulcer area (cm^2 and total percentage [%]) using the ARANZ Silhouette wound imaging and measurement device.
Percentage Change in Ulcer Area From Baseline to the End of the Treatment Period
Time frame: Baseline through 12 weeks
Ulcer area was photographed in order to determine the measurements of the postdebridement ulcer area (cm^2 and total percentage [%]) using the ARANZ Silhouette wound imaging and measurement device.

3 secondary outcomes

Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Time frame: Baseline through 12 weeks
Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Time frame: Baseline through 12 weeks
Percentage Change in Target Ulcer Depth and Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Time frame: Baseline through 12 weeks

Results and safety

Results posted to the registry on 6 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PICO System	80	62
tNPWT System	84	42

Primary outcome: Change in Ulcer Area From Baseline to the End of the Treatment Period

Time frame: Baseline through 12 weeks. Mean (Standard Deviation). Unit: cm^2

Measure	PICO System n = 64	tNPWT System n = 51
Baseline wound area	6.2 (5.9)	7.8 (6.3)
Final wound area	0.7 (1.8)	3.8 (6.7)
Change in wound area	-5.5 (5.4)	-4.0 (6.2)

PICO System vs tNPWT System: p = 0.001, Stepwise regression

Population analysed: The Per-Protocol (PP) population was used to analyze outcome measure data and included all subjects who were randomized, met inclusion/exclusion criteria, had not discontinued treatment within the first 9 weeks (-1 day), and had no significant protocol deviations.

Primary outcome: Percentage Change in Ulcer Area From Baseline to the End of the Treatment Period

Time frame: Baseline through 12 weeks. Mean (Standard Deviation). Unit: Percentage of change in wound area

Measure	PICO System n = 64	tNPWT System n = 51
Value	-88.7 (24.1)	-58.6 (63.5)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PICO System	6 of 80 (7.5%)	65 of 80 (81.3%)	2 of 80
tNPWT System	8 of 84 (9.5%)	57 of 84 (67.9%)	0 of 84

Limitations and caveats (from the sponsor): There were no known limitations or caveats reported during this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Venous Leg Ulcers

Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Not yet recruiting
Subcutaneous Dexpanthenol Administration and Wound Epithelialization
Chronic Wounds, Diabetic Foot Ulcer
Not yet recruitingPhase 2
Controlled Study, Performed to Evaluate the Safety and Efficacy of EscharEx and Its Placebo (Gel Vehicle) Compared to Non-surgical Standard of Care in Participants With Venous Leg Ulcers (VLU)
Venus Leg Ulcers
RecruitingPhase 3
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
Venous Leg Ulcer (VLU)
Not yet recruitingPhase 1/2
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
Lower Extremity, Chronic Ulcers

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. This study is not recruiting at the moment.

Andy Weymann, MD, MBA study chair

Smith & Nephew, Inc.

17 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PICO System and tNPWT System in people with Venous Leg Ulcers and Diabetic Foot Ulcers, run by Smith & Nephew, Inc. at 17 sites in 2 countries.

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 9 inclusion and 8 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: finished, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Canada. 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?

Yes. Results are posted in the registry (first posted 6 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Ulcer Area From Baseline to the End of the Treatment Period (time frame: Baseline through 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02470806.

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 6 Apr 2020.