 
The GRAFTJACKET® Matrix has been studied in the treatment of deep, chronic diabetic foot ulcers to determine the product’s ability to support the body in the repair of these ulcers.
The following body of evidence suggests that the GRAFTJACKET® Matrix is a viable treatment alternative to deep diabetic foot ulcers. These results demonstrate that by using the GRAFTJACKET® Matrix in addition to good wound care and off-loading, the body can heal challenging chronic diabetic foot ulcers, and the rate of repair is faster than standard wound care alone. The first study divided the patients into two groups. Each group received similar treatment, including sharp debridement, weekly dressing changes and standard off-loading of the ulcer. The patients in the test group additionally had one application of the GRAFTJACKET® Matrix after debridement and before the first dressing was applied. Patients were followed weekly to determine the rate of healing at 4 weeks and complete healing at 12 weeks. Study 1 Brigido SA, Boc SF, Lopez RC. Effective Management of Major Lower Extremity Wounds Using an Acellular Regenerative Tissue Matrix: A Pilot Study. Orthopedics 2004; 27(1S): s145-s149.
A second study also compares a single application of GRAFTJACKET® Matrix to sharp debridement, weekly dressing changes, and standard offloading alone. All patients were seen weekly. By week 16, 12 of 14 patients treated with GRAFTJACKET® Matrix demonstrated complete wound closure compared with 4 of 14 patients in the control group. Study 2 Brigido, SA. The Use of an Acellular Dermal Regenerative Tissue Matrix in the Treatment of Lower Extremity Wounds: A prospective 16-week Pilot Study. Accepted to International Wound Journal, 2006.
A third study included a series of 17 consecutive patients with deep ulcers. These patients were treated with sharp debridement, a single application of GRAFTJACKET® Matrix, and standard off-loading. These patients were followed for 20 weeks to determine complete healing and the average time to complete healing. Study 3 Martin BR, Sangalang M, Wu SC, Armstrong DG. Outcomes of allogenic matrix therapy in treatment of diabetic foot wounds. International Wound Journal 2005; 2(2): 161-165.
A fourth study is a small series of 11 patients with Wagner Grade I & II diabetic foot ulcers. These patients were treated with sharp debridement, a single application of GRAFTJACKET® Matrix, and standard off-loading. These patients were followed for 12 weeks to determine efficacy and healing time. Study 4 Yeager DA, Oliverio J. Investigation of GRAFTJACKET® Regenerative Tissue Matrix For Ulcer Repair on Full-Thickness Lower Extremity Ulcers. Accepted as an ACFAS 2006 Scientific Poster Exhibit.
A fifth study is a retrospective review of 15 consecutive complex wounds. Comorbidities included peripheral vascular disease, diabetes, infection, osteomyelitis, and neuropathy. Treatment included sharp debridement, infection control (if applicable, including local and systemic antibiotics), a single application of GRAFTJACKET® Matrix, and standard off-loading. The patients were followed for 12 weeks. Study 5 Liden BA, Hartman JF, Wright ML. The Use of an Acellular Regenerative Tissue Matrix for the Management of Complex Lower Extremity Wounds. Accepted as an ACFAS 2006 Scientific Poster Exhibit.
*Completely healed is defined as closure of the wound with no drainage. Published data available from WRIGHT Reimbursement Hotline at 866-533-0740.
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