Charles M Zelen1, Dennis P Orgill2, Thomas E Serena3, Robert D Galiano4, Marissa J Carter5, Lawrence A DiDomenico6, Jarrod P Kaufman7, Jennifer Keller8, Nathan J Young9, William W Li10. 1. Professional Education and Research Institute, Roanoke, VA. 2. Brigham and Women's Hospital, Boston, MA. 3. Serena Group, Cambridge, MA. 4. Northwestern University Feinberg School of Medicine, Chicago, IL. 5. Strategic Solutions, Inc, Cody, Wyoming. 6. Lower Extremity Institute of Research and Therapy, Youngstown, OH. 7. Premier Surgical, Brick, NJ. 8. Shenandoah Lower Extremity Research Institute, Troutville, VA. 9. Martinsville Research Institute, Martinsville, VA. 10. Angiogenesis Foundation, Cambridge, MA.
Abstract
BACKGROUND: Acellular matrices have been successfully used to heal indolent diabetic foot ulcers (DFUs). These tissues include allogenic dermis as well as xenograft dermis, pericardium, and small intestine submucosa. While all of these tissues show promise for healing DFUs, dermal-derived matrices have shown considerable potential. MATERIALS AND METHODS: The authors retrospectively reviewed healing in patients with DFUs that failed the standard of care (SOC) treatment from a previous prospective randomized, controlled trial (RCT). That trial compared the efficacy of human reticular acellular dermal matrices (HR-ADMs) with the SOC. Of the 16 out of 20 patients who did not heal in the SOC group, 12 were eligible for crossover treatment with the HR-ADM. The authors studied the rate of complete healing in that specific cohort after 12 weeks of crossover treatment. RESULTS: Of the 12 patients who were eligible for the HR-ADM, 10 (83%) achievedcomplete wound healing, with a mean healing time of 21 days to closure. The corresponding wound area reduction was from 1.7 cm2 to 0.6 cm2. The mean product cost to closure was $800/patient. CONCLUSION: This study further demonstrates the effectiveness of the HR-ADM in facilitating the closure of nonhealing DFUs refractory to SOC.
RCT Entities:
BACKGROUND: Acellular matrices have been successfully used to heal indolent diabetic foot ulcers (DFUs). These tissues include allogenic dermis as well as xenograft dermis, pericardium, and small intestine submucosa. While all of these tissues show promise for healing DFUs, dermal-derived matrices have shown considerable potential. MATERIALS AND METHODS: The authors retrospectively reviewed healing in patients with DFUs that failed the standard of care (SOC) treatment from a previous prospective randomized, controlled trial (RCT). That trial compared the efficacy of human reticular acellular dermal matrices (HR-ADMs) with the SOC. Of the 16 out of 20 patients who did not heal in the SOC group, 12 were eligible for crossover treatment with the HR-ADM. The authors studied the rate of complete healing in that specific cohort after 12 weeks of crossover treatment. RESULTS: Of the 12 patients who were eligible for the HR-ADM, 10 (83%) achieved complete wound healing, with a mean healing time of 21 days to closure. The corresponding wound area reduction was from 1.7 cm2 to 0.6 cm2. The mean product cost to closure was $800/patient. CONCLUSION: This study further demonstrates the effectiveness of the HR-ADM in facilitating the closure of nonhealing DFUs refractory to SOC.
Authors: Charles M Zelen; Dennis P Orgill; Thomas E Serena; Robert E Galiano; Marissa J Carter; Lawrence A DiDomenico; Jennifer Keller; Jarrod P Kaufman; William W Li Journal: Int Wound J Date: 2018-04-22 Impact factor: 3.315