Amelogenins are
extracellular matrix proteins that, under physiological conditions, self-assemble into globular aggregates up to micron-sizes. Studies with periodontal fibroblasts indicate that attachment to these structures increases the endogenous secretion of multiple
growth factors and cell proliferation. Pre-clinical and clinical studies indicate that cutaneous
wounds benefit from treatment with
amelogenins. A randomized controlled trial (RCT) involving patients with hard-to-heal venous
leg ulcers (VLUs) (ie,
ulcers with a surface > or = area 10 cm2 and duration of > or = 6 months) showed that the application of
amelogenin (Xelma, Molnlycke Health Care, Gothenburg, Sweden) as an adjunct treatment to compression results in significant reduction in
ulcer size, improvement in the state of
ulcers, reduced
pain, and a larger proportion of
ulcers with low levels of exudate, compared with treatment with compression alone.
Amelogenin therapy was also shown to be safe to use in that there were no significant differences in adverse events noted between patients treated with
amelogenin plus compression and those treated with compression alone. Case study evaluations indicate that the benefits of
amelogenin therapy demonstrated in the RCT are being repeated in "real life" situations and that
amelogenin therapy may also have a role to play in the treatment of other
wound types such as
diabetic foot ulcers.