Feasibility Study of a Novel Device for Chronic Wounds

Stanford University

Status

Completed

Conditions

Ulcer

Wounds and Injuries

Treatments

Device: SNaP Advanced Wound Care System

Other: SNaP

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00660049

IRB Protocol #: 11074 (Other Identifier)

SU-02252008-1026

Details and patient eligibility

About

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.

Full description

This is an open label study

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:- Venous stasis ulcer or other chronic wound on the lower extremity that is >1.5cm and <10cm at widest point

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.

Exclusion Criteria:- Active wound infection.

3+ 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