Publications library Research article
PRS Global Open · 2016
DiDomenico, L.A., Orgill, D.P., Galiano, R.D., Serena, T.E., Carter, M.J., Kaufman, J.P., Young, N.J., & Zelen, C.M.
Plastic and Reconstructive Surgery Global Open (PRS GO)
In this randomized controlled trial at 5 US outpatient wound centers (NCT02399826), 40 patients with non-healing diabetic foot ulcers received standard care alone or standard care plus a weekly aseptically processed dehydrated human amnion and chorion allograft for up to 12 weeks. At the 6-week primary endpoint, 70% (14/20) of allograft-treated ulcers had healed compared with 15% (3/20) with standard care alone, a statistically significant difference (P = 0.001); at 12 weeks, 85% and 25% had healed (this comparison was not statistically tested), but eight standard care patients and one allograft patient had been withdrawn at 6 weeks for less than 50% area reduction, which the authors note caused high right censoring at 12 weeks. No adverse events were judged graft related; patients and investigators were not blinded, and the trial was funded by the Musculoskeletal Transplant Foundation, which supplied the grafts.
Co-authored by Dr. Thomas Serena, SerenaGroup's founder.
Plain-language summary by SerenaGroup. See the full text for complete methods and results.
No abstract is published for this item. Use the full text link for the complete document.
