Effect of amelogenin extracellular matrix protein and compression on hard-to-heal venous leg ulcers: follow-up data.

OBJECTIVE: To undertake a follow-up of patients with hard-to-heal venous leg ulcers (VLUs) who had participated in a randomised controlled trial in which they had been treated with either compression therapy in combination with amelogenin extracellular matrix protein or compression therapy alone for 12 weeks or until their ulcers had healed, whichever occurred first.

METHOD: Patients were randomised to receive either high compression therapy plus amelogenin (n=42) or high compression therapy alone (n=41) for a period up to and including 12 weeks. The method and initial findings are detailed in an earlier paper. Twelve weeks after the final visit, the patients were followed up and the wounds were re-evaluated.

RESULTS: The initial results demonstrated clinically and statistically significant benefits for the patients in the amelogenin group. The results of the follow-up showed that the successful healing response had been maintained. Significantly more patients continued to show a reduction in ulcer size from baseline in the amelogenin-treated group versus the control group (p=0.02), and there was a statistically significant (p=0.01) larger reduction in the amelogenin-treated group. This group also had a significantly (p=0.02) higher percentage of patients with decreases in wound size. The overall number of patients with healed wounds was greater (n=9) in the amelogenin-treated group than in the control group (n=3). Pain continued to be significantly reduced in the amelogenin-treated group compared with the control group (p=0.001).

CONCLUSION: Amelogenin therapy in conjunction with high compression therapy was beneficial in the treatment of hard-to-heal VLUs when compared with treatment with high compression alone. These beneficial effects were maintained post-treatment and were identified at follow-up.