Clinical Trial: Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers

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

Official Title: A Prospective, Randomized Comparative Parallel Study of Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers

Brief Summary: Have indolent diabetic ulcers completely healed by the Acellular Porcine Dermal Matrix (APM) in 12 weeks.

Detailed Summary: The primary objective of this study is to have ulcers completely healed by the Acellular Porcine Dermal Matrix (APM) protocol in the management of indolent diabetic ulcers at 12 weeks.
Sponsor: Wright Medical Technology

Current Primary Outcome: Mann Whitney U Test [ Time Frame: 12 Weeks ]

We will evaluate the influence of continuous variables' effect on healing in general using a Mann Whitney U test. Dichotomous variables will be evaluated with a chi-squared test with odds ratio and 95% confidence interval (CI). To evaluate the healing characteristics of each modality as a function of weeks of therapy and mean number of days to closure amongst patients healing within the 12-week study period, we will use a Kaplan-Meier life table analysis (log-rank test).


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Wright Medical Technology

Dates:
Date Received: May 11, 2011
Date Started: April 2010
Date Completion:
Last Updated: June 6, 2011
Last Verified: June 2011