Comparing Human Amniotic Allograft and Standard Wound Care When Using Total Contact Casting in the Treatment of Patients with Diabetic Foot Ulcers.

OBJECTIVE

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.

PARTICIPANTS

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 cm 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.

INTERVENTIONS

Group A treatment: total contact cast and a skin substitute (human amniotic allograft); group B treatment: total contact cast and standard wound care.

OUTCOME MEASURES

Mean ulcer surface area, time to closure, recurrence rates, satisfaction with total contact casting, infection, and hemoglobin A1c were measured.

RESULTS

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%).

CONCLUSIONS

Although significance was not established because of sample size, there was a definite trend toward significance that merits further investigation with human amniotic allograft.