Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Pressure Wound Therapy System (OG/SNaP)

KCI USA, Inc

Status: Withdrawn

Conditions: Diabetic Foot Ulcer

Study type: Observational

Funder types: Industry

Identifiers

NCT01623882

041311

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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