NCT01353495

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Stryker Trauma and Extremities · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The primary objective of this study is time -to - healing with wound size determination at 12 weeks.

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
DEVICE	APM Graft (BIOTAPE XMTM)	Patients randomized to the APM group will, following surgical debridement for their diabetic foot wounds, receive a single application of an APM graft (BIOTAPE XMTM, Wright Medical Technology, USA) with dressing changes taking place weekly. All necrotic tissue will be removed from the wound prior to application. BIOTAPE XMTM will be sutured or stapled in place under a silver-based non-adherent dressing (Silverlon, Argenta Medical). Therapy will then be followed by a moisture-retentive dressing (hydrogel bolster) until complete epithelialization has occurred.
OTHER	Wound Debridement	Wounds debrided in both arms of study

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-10-01
• Completion: 2011-04-01
• First posted: 2011-05-13
• Last updated: 2021-06-14
• Results posted: 2021-06-14

Locations

2 sites across 1 country: United States