Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Pressure Wound Therapy System (OG/SNaP)
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ClinicalTrials.gov Identifier: NCT01623882
Recruitment Status :
(The study was terminated by Spiracur (original sponsor). Efforts were made to contact the PI/study team members, but were unsuccessful.)
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with lower extremity venous and diabetic ulcers.
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
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.