This prospective, randomized study compared two treatments for diabetic foot ulcers: total contact cast and a skin substitute versus total contact cast and standard wound care.
Researchers screened 270 adult outpatients in a Midwestern wound care clinic for inclusion. Adults 18 years or older with type 1 or 2 diabetes and a diabetic foot ulcer located on the plantar surface larger than 0.5 cm2 in area were invited to participate if they had not demonstrated a 50% reduction in wound area following 4 weeks of standard treatment. Thirteen patients were randomized into two intervention groups. The majority of the participants had type 2 diabetes.
Group A treatment: total contact cast and a skin substitute (human amniotic allograft); group B treatment: total contact cast and standard wound care.
Mean ulcer surface area, time to closure, recurrence rates, satisfaction with total contact casting, infection, and hemoglobin A1c were measured.
The majority of participants experienced wound closure during the course of the study (92.3%). Two participants did not achieve closure, both of whom had Charcot foot. Group A, which had a higher mean hemoglobin A1c at study outset, experienced a longer mean time to closure (29.50 days) compared with group B (26.20 days). The 90-day recurrence rates were different for the two groups, with only one recurrence for group A (14.29%) but five recurring ulcers in group B (83.33%).
Although significance was not established because of sample size, there was a definite trend toward significance that merits further investigation with human amniotic allograft.
At the University of North Dakota College of Nursing & Professional Disciplines in Grand Forks, North Dakota, Patricia Thompson, MS, RN, is a Clinical Associate Professor; Darlene S. Hanson, PhD, RN, is a Clinical Professor; and Diane Langemo, PhD, RN, FAAN, is a Professor Emeritus. Julie Anderson, PhD, RN, is Dean of Nursing and Health Sciences, Winona State University, Winona, Minnesota.
Acknowledgments: The authors thank Keith Swanson, MD, and Dianne Vold, Clinical Research Coordinator at Altru Wound Care Clinic, Grand Forks, North Dakota. This study was supported in part by Derma Sciences, Inc, who provided allografts for all subjects in the study, and instant total contact casts for those few patients without third party reimbursement. The authors have disclosed no other financial relationships related to this article. Submitted May 4, 2018; accepted in revised form August 16, 2018.