OBJECTIVE: The objective of this multicenter study was to prospectively evaluate the healing outcomes of chronic diabetic foot ulcers (DFUs) treated with PriMatrix (TEI Biosciences, Boston, Massachusetts), a fetal bovine acellular dermal matrix.
METHODS: Inclusion criteria required the subjects to have a chronic DFU that ranged in area from 1 to 20 cm2 and failed to heal more than 30% during a 2-week screening period when treated with moist wound therapy. For qualifying subjects, PriMatrix was secured into a clean, sharply debrided wound; dressings were applied to maintain a moist wound environment, and the DFU was pressure off-loaded. Wound area measurements were taken weekly for up to 12 weeks, and PriMatrix was reapplied at the discretion of the treating physician.
RESULTS: A total of 55 subjects were enrolled at 9 US centers with 46 subjects progressing to study completion. Ulcers had been in existence for an average of 286 days, and initial mean ulcer area was 4.34 cm2. Of the subjects completing the study, 76% healed by 12 weeks with a mean time to healing of 53.1 ± 21.9 days. The mean number of applications for these healed wounds was 2.0 ± 1.4, with 59.1% healing with a single application of PriMatrix and 22.9% healing with 2 applications. For subjects not healed by 12 weeks, the average wound area reduction was 71.4%.
CONCLUSION: The results of this multicenter prospective study demonstrate that the use of PriMatrix integrated with standard-of-care therapy is a successful treatment regimen to heal DFUs.
Steven J. Kavros, DPM, is an Associate Professor of Podiatric Medicine, Mayo Clinic College of Medicine, and holds appointments in the Department of Orthopedic Surgery, Sections of Vascular Medicine, and Occupational, Preventitive, and Aerospace Medicine at the Mayo Clinic, Rochester, Minnesota. Timothy Dutra, DPM, is an Assistant Clinical Professor, Department of Applied Biomechanics and Clinical Investigator for the California School of Podiatric Medicine at Samuel Merritt University in Oakland, California. Renier Gonzalez-Cruz, MD, is Director of the Wound Care Clinic at the Hospital Metropolitano Dr Pila in Ponce, Puerto Rico; consulting physician at Casa del Veterano and San Cristobal Medical Center in Juana Diaz, Puerto Rico; and Attending Physician at the Hospital Dr Pila, Family Medicine Residency in Ponce, Puerto Rico. Brock Liden, DPM, is the owner of Reynoldsburg Podiatry Center LLC in Reynoldsburg, Ohio, and owner of Circleville Foot & Ankle LLC in Circleville, Ohio. Belinda Marcus, MD, is the Medical Director at HyperbaRXs in Cumming, Georgia. James McGuire, DPM, is an Associate Professor and Director of the Leonard Abrams Center for Advanced Wound Healing at the Temple University School of Podiatric Medicine in Philadelphia, Pennsylvania. Luis Nazario-Guirau, MD, is the Medical Director at the Auxilio Centro de Heridas y Medicina Hiperbarica in San Juan, Puerto Rico. Dr McGuire has disclosed that he is a consultant for Devon Medical, Zeomedix, TEI Biosciences, Healthpoint LTD, Steadmed Medical, BSN Medical, Medline Inc, Hollister, and Shire Dermagraft; and his institution received study grants from Diapedia LLC and Drexel University.
The other authors have disclosed that they have no financial relationships related to this article.
Acknowledgments: TEI Biosciences, the manufacturer of PriMatrix, provided financial support for this prospective study. This enabled the sites the opportunity to collect data and pay for institutional review board fees.
Submitted August 8, 2013; accepted in revised form February 4, 2014.