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

November 21, 2024 updated by: KCI USA, Inc

Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Negative Pressure Wound Therapy System for Treatment of Non-responding Venous Stasis and Diabetic Lower Extremity Ulcers

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 Overview

Status

Withdrawn

Conditions

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with lower extremity venous and diabetic ulcers.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of wounds closed
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KCI USA, Inc

Collaborators

3M
Organogenesis

Investigators

  • Principal Investigator: Peter Schubart, MD, PhD, O'Connor Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 18, 2012

First Submitted That Met QC Criteria

June 19, 2012

First Posted (Estimated)

June 20, 2012

Study Record Updates

Last Update Posted (Actual)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 041311

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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