Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetic Foot Ulcers Venous Leg Ulcers

Keywords

Venous leg ulcerulcervenous stasiscompressiondiabetic foot ulcersdfuvlu

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 SystemDevice

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

PICO System

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.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Provide informed consent
Age ≥ 18 years and of either sex

Sponsors & Collaborators

Smith & Nephew, Inc.
Industrylead

Study Sites (17)

ILD Consulting, Inc.

Carlsbad, California, 92009, United States

Valley Foot & Ankle Specialty Providers

Fresno, California, 93720, United States

The Sun Healthcare & Surgery Group

Martinez, California, 94553, United States

Center for Clincial Research

San Francisco, California, 94115, United States

Olive View - UCLA Medical Center

Sylmar, California, 91342, United States

University of Miami

Miami, Florida, 33125, United States

NW University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

MeSH Terms

Conditions

Diabetic FootVaricose UlcerUlcer

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

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.

Study Officials

Andy Weymann, MD, MBA
Smith & Nephew, Inc.
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

164 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (2)

PICO System

tNPWT System

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (17)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (2)

PICO System

tNPWT System

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (17)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations