To be eligible for the Phase II study, patients must have a leg ulcer that has not healed for at least 6 months. If recurrent, it must have recurred for at least three months. If randomized to the control arm, patients can be crossed-over to receive Butyrate after three months. A port or indwelling line is necessary to receive Butyrate, due to hypertonicity of the solution, which is similar to nutritional hyperalimentation, containing one amino acid and one fatty acid. The port can be removed after completion of the study and healing of the ulcer.
Treatment can be a home therapy with a portable pump.
Patients selected for home therapy must complete educational competencies on sterile infusion techniques and agree to be monitored by a home care company. Patients who can come to Boston for 3 months for the study are also very welcome. We can arrange low-cost housing. Introductions were made. Dr. Rucknagel proposed a set of variables for collection, along with a brief review of the literature concerning the possibility of development of malignancy associated with HU therapy.