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Clinical Evaluation of the Co...

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

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Diabetic Foot Ulcer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers