Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Pressure Wound Therapy System

KCI USA, Inc

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Diabetic Foot Ulcer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of wounds closed

Time frame: 12 weeks

Data from ClinicalTrials.gov

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