Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Pressure Wound Therapy System
Withdrawn
- Conditions
- Diabetic Foot Ulcer
- Registration Number
- NCT01623882
- Lead Sponsor
- KCI USA, Inc
- Brief Summary
The primary purpose of this study is to evaluate the safety and efficacy of the concurrent use of Apligraf® and the SNaP® Wound Care System for the treatment of diabetic and venous stasis lower extremity ulcers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Wound < 10 cm in greatest diameter
- Wound age > 4 weeks and patient shows < 50% wound area healing after 4 weeks of treatment
- Patient > 18 years of age
- Patient is willing and able to sign consent
- Patient is willing and able to complete study visits and comply with study dressing protocols
Exclusion Criteria
- Wound size reduction of > 50% in last 4 weeks of treatment
- Patients with active wound infections, including cellulitis and osteomyelitis
- Patients with wounds not able to have eschar debrided
- ABI < 0.65 or SPP < 30mmHg
- Patients with wounds in anatomic areas which preclude achieving an airtight seal for NPWT
- Ulcers due to inflammatory conditions such as rheumatoid arthritis, lupus, scleroderma, vasculitis, calciphylaxis, etc.
- Patients with allergy to or intolerance of any of the wound dressing materials expected to be used during the trial.
- Pregnant patients
- Patients unable to tolerate NPWT
- Patients with dialysis dependent ESRD
- Index ulcer is on the plantar surface of the foot
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of wounds closed 12 weeks
- Secondary Outcome Measures
Name Time Method