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: Patients randomised to receive EpiFix had higher healing rates than those receiving standard of care without EpiFix (Table2). At 4 weeks, none of the subjects from the SOC group (0%) was healed, whereas 10 of the 13 subjects in the EpiFix group (77%) had wounds that had completely epithelialised (P < 0·001). At 6 weeks, 1 of the 12 subjects from the SOC group (8%) was healed and 12 of the 13 subjects in the EpiFix group (92%) were healed (P < 0·001). Rates of healing by week are illustrated in Figure 3. Interestingly, over 50% of patients in the EpiFix group were healed (defined as complete epithelialisation of the open area of the wound) within 1 week of study enrolment.
Affiliation: Department of Clinical Research, Professional Education and Research Institute, Inc., Roanoke, VA, USA.