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

NCT02470806 | Completed Results

• 1 other identifier: CE-052PIC
• Study Type: interventional
• Target: 164
• Locations: 2 countries
• Sites: 17

Brief 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.

Conditions

Venous Leg Ulcers; Diabetic Foot Ulcers

Keywords

Venous leg ulcer; ulcer; venous stasis; compression; diabetic foot ulcers; dfu; vlu

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  Baseline through 12 weeks

• Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period

  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

  Baseline through 12 weeks

Study Arms (2)

PICO System

EXPERIMENTAL

Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface

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.

Device: tNPWT System

Interventions

PICO System DEVICE

Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface

PICO System

tNPWT System DEVICE

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.

tNPWT System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (17)

ILD Consulting, Inc.

Carlsbad, California, 92009, United States

Location

Valley Foot & Ankle Specialty Providers

Fresno, California, 93720, United States

Location

The Sun Healthcare & Surgery Group

Martinez, California, 94553, United States

Location

Center for Clincial Research

San Francisco, California, 94115, United States

Location

Olive View - UCLA Medical Center

Sylmar, California, 91342, United States

Location

University of Miami

Miami, Florida, 33125, United States

Location

NW University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Rosalind Franklin University of Med & Science

North Chicago, Illinois, 60064, United States

Location

Ochsner Health System

New Orleans, Louisiana, 70121, United States

Location

Rubin Institute for Advanced Orthopedics

Baltimore, Maryland, 21215, United States

Location

Advanced Foot & Ankle

Las Vegas, Nevada, 89119, United States

Location

Center for Advanced Wound Care

Wyomissing, Pennsylvania, 19610, United States

Location

Acclaim Bone & Joint

Fort Worth, Texas, 76104, United States

Location

Futuro Clinical Trials, LLC

McAllen, Texas, 78501, United States

Location

Carilion Clinic

Roanoke, Virginia, 24013, United States

Location

The Mayer Institute

Hamilton, Ontario, L8R 2R3, Canada

Location

Centre podiatrique et soins des plaies

Boucherville, Quebec, J4B 5E4, Canada

Location

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer; Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

There were no known limitations or caveats reported during this study.

Results Point of Contact

• Title: Natasha Schappell, CCRP
• Organization: Smith & Nephew, Inc.

natasha.schappell@smith-nephew.com

817-302-3949

Study Officials

• Andy Weymann, MD, MBA

  Smith & Nephew, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 12, 2015
• Study Start: July 2, 2015
• Primary Completion: November 14, 2017
• Study Completion: November 14, 2017
• Last Updated: April 6, 2020
• Results First Posted: April 6, 2020

Record last verified: 2020-04

Locations

US (15); CA (2)