NCT00660049

Brief Summary

The purpose of this study is to evaluate the feasibility and usability of a new portable and compact wound dressing device for the treatment of small chronic skin wounds.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 17, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

January 20, 2017

Completed
Last Updated

December 13, 2017

Status Verified

November 1, 2017

Enrollment Period

2.3 years

First QC Date

April 4, 2008

Results QC Date

May 26, 2016

Last Update Submit

November 15, 2017

Conditions

UlcerWounds and Injuries

Outcome Measures

Primary Outcomes (1)

  • Ease of Use for Patients

    Participants were given instructions to use the SNaP device home. Participants completed a questionnaire reporting whether the device was easy to use, worthwhile to use, and whether they would use the device again. Numbers responding positively to each question are presented.

    Baseline up to 31 days

Study Arms (1)

SNaP application

EXPERIMENTAL

This is an "open label" pilot study of SNaP Advanced Wound Care System

Device: SNaP Advanced Wound Care SystemOther: SNaP

Interventions

SNaP Advanced Wound Care SystemDEVICE

Application of negative pressure device daily per instructions

Also known as: SNaP device (SmartNegative Pressure device)
SNaP application
SNaPOTHER

Daily use

Also known as: SNaP device
SNaP application

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The wound must have at least 2 cm of intact epithelium surrounding it.
  • A wound such as a pressure ulcer or chronic ulcer on a location other than the lower extremity may also be included in the study if it meets the size requirements and a reliable seal can be achieved.
  • Ulcer must not have healed for \>14 days under standard treatment.
  • Chronic wound with prior graft placement will be allowed in the study.
  • Patient is \>18 years old.
  • Willing and able to sign informed consent.

You may not qualify if:

  • + or greater pitting edema of lower extremity
  • History of malignancy at wound site. However, wounds that are closing by secondary intent after surgical clearance of prior tumor will be allowed in the study.
  • Thick eschar at wound base after debridement.
  • Wound location is not amenable to forming an airtight seal and placement of device.
  • Ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinemia, necrobiosis lipoidica diabeticorum, lupus or pancreatic panniculitis, cryofibrinogenemia, calcinosis cutis, scleroderma, Raynaud's syndrome.
  • Current smoker (must have quit for \>3 weeks)
  • Wound with exposed bone, blood vessels, tendon
  • Significant immunosuppression (as determined by the investigator and sponsor) such as high dose prednisone
  • Fasting blood sugar \>200 by study personnel administered bedside fingerstick blood glucose
  • Ankle brachial index less than lower limit of normal (\<0.60) as performed and determined by licensed physician (necessary only for patients with lower extremity wounds).
  • Pregnancy
  • Incapable of giving informed consent
  • Inability to comply with study procedures including lack of telephone access for week 8 telephone survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

  • Fong KD, Hu D, Eichstadt SL, Gorell E, Munoz CA, Lorenz HP, Chang AL. Initial clinical experience using a novel ultraportable negative pressure wound therapy device. Wounds. 2010 Sep;22(9):230-6.

    PMID: 25901554BACKGROUND

MeSH Terms

Conditions

UlcerWounds and Injuries

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

Open label design without comparator arm

Results Point of Contact

Title
Anne Chang, MD
Organization
Stanford University
alschang@stanford.edu
(650) 721 7151

Study Officials

  • Dr. Anne Lynn S. Chang

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 4, 2008

First Posted

April 17, 2008

Study Start

March 1, 2008

Primary Completion

July 1, 2010

Study Completion

August 1, 2010

Last Updated

December 13, 2017

Results First Posted

January 20, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

No sharing

Locations

US(1)