Lower-Extremity Ulcers due to Venous Insufficiency

For individuals who have lower-extremity ulcers due to venous insufficiency who receive a patch or
flowable formulation of HAM, the evidence includes 2 RCTs. Relevant outcomes are symptoms, morbid
events, functional outcomes, and quality of life. The published evidence on HAM for the treatment of
venous leg ulcers includes 2 multicenter RCTs with EpiFix. One RCT reported a larger percent wound
closure at 4 weeks, but the percentage of patients with complete wound closure at 4 weeks did not differ
between EpiFix and the standard of care. A second RCT evaluated complete wound closure at 12 weeks
after weekly application of EpiFix or standard dressings with compression, but interpretation is limited by
methodologic concerns. Two additional studies with other HAM products have been completed but not
published, raising further questions about the efficacy of HAM for venous insufficiency ulcers. Therefore,
corroboration with well-designed and well-conducted RCTs evaluating wound healing is needed to
demonstrate efficacy for this indication. The evidence is insufficient to determine the effects of the
technology on health outcomes.

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