A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers.
Bottom Line: In the standard care group (n = 12) and the EpiFix group (n = 13) wounds reduced in size by a mean of 32.0% ± 47.3% versus 97.1% ± 7.0% (P < 0.001) after 4 weeks, whereas at 6 weeks wounds were reduced by -1.8% ± 70.3% versus 98.4% ± 5.8% (P < 0.001), standard care versus EpiFix, respectively.Patients treated with EpiFix achieved superior healing rates over standard treatment alone.These results show that using EpiFix in addition to standard care is efficacious for wound healing.
Affiliation: Department of Clinical Research, Professional Education and Research Institute, Inc., Roanoke, VA, USA.Show MeSH
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Mentions: Study outcomes are presented in Table2. At 4 weeks, the average ulcer surface area reduction was 32·0% ± 47·3% for the 12 subjects of the SOC group and 97·1% ± 7·0% for the 13 subjects of the EpiFix group (P < 0·001). At 6 weeks, the average ulcer surface area reduction was −1·8% ± 70·3% for the 12 subjects of the SOC group and 98·4% ± 5·8% for the 13 subjects of the EpiFix group (P < 0·001). Mean wound area reduction by week is presented in Figure 1. In the SOC group there was a mean reduction in wound size of 20% at week 1, compared to a mean reduction in wound size of over 80% in those in the EpiFix group. Mean wound size reduction by patient is presented in Figure 2 for those in the EpiFix and SOC groups, respectively. Note that the SOC patients showed the typical pattern of irregular wound size variation over time, whereas the EpiFix patients demonstrated a consistently rapid reduction in wound size over time with less variation.
Affiliation: Department of Clinical Research, Professional Education and Research Institute, Inc., Roanoke, VA, USA.