EpiFix for chronic wounds

The technology described in this briefing is EpiFix, an amniotic membrane allograft comprised of dehydrated human amniotic membrane. This briefing focuses on its use in treating chronic wounds such as diabetic foot ulcers and venous leg ulcers.

The innovative aspect is that it is an allograft of human amniotic membrane. It therefore differs from most wound-care products in being regulated as a human tissue product.

The intended place in therapy would be as an alternative to other advanced wound dressings for chronic, difficult-to-heal wounds in addition to standard treatments.

The main points from the evidence summarised in this briefing are from 5 studies, including 3 studies in people with difficult-to-heal diabetic foot ulcers and 2 studies in people with venous leg ulcers. The total number of people in the studies is not clear because the trials include overlapping populations. The studies suggest that EpiFix may be an effective addition to standard care and compression therapy in people with chronic wounds.

Key uncertainties around the evidence or technology are that all studies took place in the US and so comparisons and patient selection may not be generalisable to the NHS. In particular, there are no comparisons of EpiFix with standard NHS care for any indication. Two of the 5 studies included were written by the same group of authors (Zelen et al.) and 4 studies were funded by the company. Four other studies are ongoing, and 5 studies have been completed but not published.

The cost of EpiFix is £1,018.39 per unit (2 cm × 3 cm; excluding VAT) for 1 treatment. Multiple treatments are usually needed. The resource impact would be a significant additional cost to standard care, which might be offset if the technology allows faster wound healing. There is no published economic evidence on using EpiFix.