A trial to assess the efficacy and tolerability of Hyalofill-F in non-healing venous leg ulcers.

OBJECTIVE

This single-centre, open, uncontrolled pilot clinical trial set out to assess the efficacy and tolerability of Hyalofill-F (a partial benzyl ester derivative of hyaluronan), used in combination with compression bandaging, in the treatment of venous leg ulcers.

METHOD: The 20 patients enrolled into the study had venous insufficiency and a leg ulcer that had been refractory to treatment for one month. Treatment was continued for eight weeks, with weekly assessments.

RESULTS

During the study period four of the patients' ulcers healed completely. An average wound area reduction of 53.5% was seen in the ulcers that did not heal. Differences in ulcer area and ulcer depth between the initial and final visit were significant (p < 0.01, p = 0.03). The average healing rate (cm2/week reduction) was 1.26 +/- 1.7 (standard deviation). A calculated prognostic index was used to identify patients at high risk of a poor response to compression therapy (10% probability of wound closure at 120 weeks). These patients demonstrated a mean 63% decrease in wound area after eight weeks of treatment with Hyalofill-F plus compression bandaging. All wounds showed a positive response in terms of granulation-tissue formation. The comfort of the dressing was described as excellent.

CONCLUSION

The hyaluronan derivative showed promising results in initiating the healing process in chronic venous ulcers. It was found to be well tolerated and safe to use. However, further clinical trials should be performed involving a control group to verify these data.

DECLARATION OF INTEREST: This study was sponsored by Fidia Advanced Biopolymers, Italy.