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

Diabetic Foot Ulcers Clinical Trial

— NPWT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02470806
• Other study ID #: CE-052PIC
• Status: Completed
• Phase: N/A
• Start date: July 2, 2015
• Est. completion date: November 14, 2017

Study information

• Verified date: April 2020
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: November 14, 2017
• Est. primary completion date: November 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA:

• 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

EXCLUSION CRITERIA

• 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)

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcers

Intervention

Device:
• PICO System
Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface
• tNPWT System
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.

Locations

Country	Name	City	State
Canada	Centre podiatrique et soins des plaies	Boucherville	Quebec
Canada	The Mayer Institute	Hamilton	Ontario
United States	Rubin Institute for Advanced Orthopedics	Baltimore	Maryland
United States	ILD Consulting, Inc.	Carlsbad	California
United States	NW University Feinberg School of Medicine	Chicago	Illinois
United States	Acclaim Bone & Joint	Fort Worth	Texas
United States	Valley Foot & Ankle Specialty Providers	Fresno	California
United States	Advanced Foot & Ankle	Las Vegas	Nevada
United States	The Sun Healthcare & Surgery Group	Martinez	California
United States	Futuro Clinical Trials, LLC	McAllen	Texas
United States	University of Miami	Miami	Florida
United States	Ochsner Health System	New Orleans	Louisiana
United States	Rosalind Franklin University of Med & Science	North Chicago	Illinois
United States	Carilion Clinic	Roanoke	Virginia
United States	Center for Clincial Research	San Francisco	California
United States	Olive View - UCLA Medical Center	Sylmar	California
United States	Center for Advanced Wound Care	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Baseline through 12 weeks
Secondary	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.	Baseline through 12 weeks
Secondary	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.	Baseline through 12 weeks