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A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix
| Content Provider | Scilit |
|---|---|
| Author | Cazzell, Shawn Moyer, Peter M. Samsell, Brian Dorsch, Kimberly McLean, Julie Moore, Mark A. |
| Copyright Year | 2019 |
| Description | Journal: Advances in Skin & Wound Care This prospective, multicenter study evaluated the efficacy and safety of an acellular dermal matrix allograft, DermACELL (D-ADM; LifeNet Health, Virginia Beach, Virginia), in the treatment of large, complex diabetic foot ulcers (DFUs) that probed to tendon or bone. Inclusion criteria were Wagner grade 3 or 4 DFUs between 4 weeks and 1 year in duration. All participants received one application of D-ADM at baseline and could receive one additional application if wound healing arrested. Ulcers were assessed weekly for 16 weeks using a laser measuring device. Sixty-one participants were enrolled, with an average wound area of 29.0 cm2; 59 of these ulcers showed exposed bone. The entire per-protocol population (n = 47) achieved 100% granulation. The mean time to 100% granulation was 4.0 weeks with an average of 1.2 applications of D-ADM. Mean percent wound area reduction was 80.3% at 16 weeks. Those DFUs 15 cm2 or smaller were substantially more likely to close than DFUs larger than 29 cm2 (P = .0008) over a 16-week duration. No complications were associated with the use of the studied matrix. The D-ADM demonstrated the ability to rapidly reduce the size of large, complex DFUs with exposed bone. Some wounds did not completely heal by 16 weeks; however, the significant reduction in size suggests that these large, complex wounds may heal if given more time. |
| Related Links | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7328871/pdf |
| Ending Page | 415 |
| Page Count | 7 |
| Starting Page | 409 |
| ISSN | 15277941 |
| e-ISSN | 15388654 |
| DOI | 10.1097/01.asw.0000569132.38449.c0 |
| Journal | Advances in Skin & Wound Care |
| Issue Number | 9 |
| Volume Number | 32 |
| Language | English |
| Publisher | Ovid Technologies (Wolters Kluwer Health) |
| Publisher Date | 2019-09-01 |
| Access Restriction | Open |
| Subject Keyword | Journal: Advances in Skin & Wound Care Acellular Dermal Matrix Diabetic Foot Ulcer Wound Healing |
| Content Type | Text |
| Resource Type | Article |
| Subject | Advanced and Specialized Nursing Dermatology |
