Application of Living Skin Equivalent for the Treatment
The authors reviewed 22 patients who received living skin equivalent (LSE) (Apligraf, Organogenesis, Inc., Canton, Massachusetts) over 20 months in whom conventional therapy had failed. Ten patients had chronic venous insufficiency, and six patients had ulcers caused by venous stasis, diabetes mellitus, and arterial insufficiency. The remaining ulcers were attributed to connective tissue disease, trauma, radiation, cryoglobulinemia, and necrobiotic xanthogranuloma. Eight patients were diabetic. The mean duration of ulceration before LSE placement was 15 months. The mean ulcer size was 48mm. Patients were followed up weekly for eight weeks and then monthly for at least 22 months. Fourteen patients healed completely; treatment failed in eight.

Nonhealing lower-extremity ulcers are a major cause of physical disability and diminished quality of life. In addition, persistent ulcers have an enormous impact on the use of healthcare resources.

A bioengineered living skin replacement (LSE), (Apligraf, Organogenesis Inc., Canton, Massachusetts) has been approved by the US Food and Drug Administration (FDA) for use with standard therapeutic compression in the treatment of noninfected partial- and full-thickness skin ulcers due to venous insufficiency of longer than one month's duration that have not responded adequately to conventional ulcer therapy. LSE has also received FDA approval for use in patients with diabetic foot ulcers, principally full-thickness neuropathic diabetic foot ulcers of more than three weeks duration that have failed conventional ulcer therapy and extend through the dermis but without tendon, muscle, capsule, or bone exposure.

Although the utility of LSE has been evaluated in the specific management of hard-to-heal venous and diabetic foot ulcers, data are limited regarding general applicability of this therapy for ulcers that are multifactorial or from other distinct causes. To evaluate further the efficacy of LSE in management of all hard-to-heal ulcers, the authors retrospectively reviewed their experience during a 20-month period.