Clinical trial NCT00660049: Feasibility Study of a Novel Device for Chronic Wounds
Official title: Feasibility Study of a Novel Device for Chronic Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcer
Wounds and Injuries
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: 3M
First posted: 2008-04-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This is an open label study

Eligibility 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

Primary outcomes:
measure: Ease of Use for Patients
timeFrame: Baseline up to 31 days
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Dr. Anne Lynn S. Chang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.