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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 | Semantic Scholar |
|---|---|
| Author | Cazzell, Shawn M. Moyer, Peter Samsell, Brian Dorsch, Kimberly McLean, Julie Moore, Mark A. |
| Copyright Year | 2019 |
| Abstract | ABSTRACT OBJECTIVE 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. METHODS 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. RESULTS 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. CONCLUSIONS 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. |
| Starting Page | 409 |
| Ending Page | 415 |
| Page Count | 7 |
| File Format | PDF HTM / HTML |
| DOI | 10.1097/01.ASW.0000569132.38449.c0 |
| PubMed reference number | 31361269 |
| Journal | Medline |
| Volume Number | 32 |
| Alternate Webpage(s) | https://www.lifenethealth.org/sites/default/files/files/PUBLISHED_A_Prospective,_Multicenter,_Single_Arm_Clinical_99946.pdf |
| Alternate Webpage(s) | https://doi.org/10.1097/01.ASW.0000569132.38449.c0 |
| Journal | Advances in skin & wound care |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |
