The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers (DFU) and venous stasis ulcers (VSU).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
202
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).
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).
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.
Institute for Advanced Wound Care
Montgomery, Alabama, United States
Southern Arizona VA Health Care System
Tucson, Arizona, United States
ILD Research Center
Carlsbad, California, United States
Effect of DermACELL on the proportion of chronic wounds of the lower extremity that have healed.
The primary outcome is the comparison of the proportion of chronic wounds treated with DermACELL and treated with conventional care that have achieved 100% re-epithelialization without dressing or drainage requirements at 12 weeks. Wound closure is defined as first observation of 100% re-epithelialization without drainage or dressing requirements and complete wound closure is defined as 100% re-epithelialization without dressing or drainage requirements confirmed at two consecutive study visits 2 weeks apart.
Time frame: 12 weeks
Proportion of wounds closed at 12 weeks and weekly thereafter for up to 24 weeks
The proportion of subjects with closed wounds at 12 weeks and weekly thereafter will be compared in subjects treated with DermACELL, GraftJacket (Diabetic foot ulcer subjects only) and conventional care wound management. A comparison of the proportion of subjects who received a second application of acellular dermal matrix will be made between the DermACELL and GraftJacket arms in those subjects with diabetic foot ulcers.
Time frame: 24 weeks
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Center for Clinical Research
Castro Valley, California, United States
Limb Preservation Platform
Fresno, California, United States
Limb Preservation Platform
Fresno, California, United States
Fairfield County Foot Surgeons
Norwalk, Connecticut, United States
Andrews Research and Education Institute
Gulf Breeze, Florida, United States
Rosalind Franklin University, CLEAR
North Chicago, Illinois, United States
Boston Medical College
Boston, Massachusetts, United States
...and 2 more locations