Clinical Trial: Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabetic Foot Ulcers Receiving VAC Negatvie Pressure Wound Therapy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Single Arm, Prospective Clinical Trial Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabectic Foot Ulcers Receiving VAC Negative Pressure Therapy

Brief Summary: The study is aimed at evaluating the clinician's preceived ease of using the V.A.C. GranuForm bride dressing and the patients perceived level of comfort during the dressing wear.

Detailed Summary: The objective of this study is to evaluate the ease of use of the V.A.C® GranuFoam™ Bridge dressing on Diabetic Foot Ulcers under ActiV.A.C® negative pressure wound therapy for a period of 48-72 hrs (+6hrs). Ease of use will be determined based on the feedback on the following characteristics 1) Ease of dressing application 2) Ease of dressing removal and 3) Ease of dressing conformability. Additionally patient feedback on comfort during wear will also be collected. Patients currently prescribed to V.A.C.® Therapy will be enrolled in the trial.
Sponsor: KCI USA, Inc.

Current Primary Outcome: Percentage of subjects with satisfactory performace, defined as a cumulative eas of use score >6 and a munimum score of >2 on each indiviual charecteristic [ Time Frame: 48-72 hours (+6 hours) time period ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Percentage of subjects with a score of >2 on the patient comfort during wear assessment [ Time Frame: 48-72 hours (+6 hrs) time period ]

Original Secondary Outcome: Same as current

Information By: KCI USA, Inc.

Dates:
Date Received: February 17, 2009
Date Started: February 2009
Date Completion:
Last Updated: September 8, 2011
Last Verified: September 2011