NCT01970163

DermACELL in Subjects With Chronic Wounds of the Lower Extremities

A Multicenter, Randomized, Controlled, Open Label Trial of DermACELL in Subjects With Chronic Wounds of the Lower Extremities

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: LifeNet Health · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers (DFU) and venous stasis ulcers (VSU).

Detailed description

This study is designed to demonstrate the effectiveness of DermACELL in the treatment of chronic wounds of the lower extremities. DermACELL will be compared to conventional care in both subjects with diabetic foot ulcers (DFU) and subjects with venous stasis ulcers (VSU). In addition, DermACELL will be compared to an active comparator, GraftJacket, in subjects with diabetic foot ulcers. DermACELL and GraftJacket are both made from donated human skin (dermis). These products have been processed so that cells are removed and bacteria and viruses are destroyed. This processing provided a supporting structure, an acellular dermal matrix, into which cells can migrate and divide during the wound healing process.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
OTHER	DermACELL	Acellular dermal matrix is applied at Baseline visit. The study product may be reapplied an additional time (between Weeks 2 and 12 for venous stasis ulcers and between Weeks 3 and 12 for diabetic foot ulcers).
OTHER	GraftJacket	Acellular dermal matrix applied at Baseline visit. May be reapplied one additional time during study (between Week 2 and 12 for venous stasis ulcers and Week 3 and 12 for diabetic foot ulcers).
OTHER	Conventional Care Dressings	Depending on the state of the wound (dry or moist), different types of nonadherent dressings would be utilized as the primary dressing: * If the wound is dry, a nonadherent dressing, such an oil emulsion dressing, may be appropriate, as these dressings tend to donate moisture to the wound. * Hydrogels can also be used if the wound is in need of moisture. * For a wound that is more moist, a more absorptive dressing may be more appropriate to help reduce potential for maceration. A secondary dressing may be desired to add either loft or cushion.

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-01-01
• Completion: 2016-04-01
• First posted: 2013-10-25
• Last updated: 2018-03-14

Locations

12 sites across 1 country: United States