Safety and effect of topical recombinant human interleukin‐1β in the management of pressure sores

Interleukin‐1β is produced by numerous cell types including monocytes and fibroblasts. It has been shown to stimulate multiple cell types including fibroblasts, keratinocytes, endothelial cells, neutrophils, macrophages, and lymphocytes. Previously, interleukin‐1β was shown to accelerate healing in partial‐thickness and full‐thickness wounds in animals and was also shown to be safe when applied topically in Phase I human trials. Therefore a prospectively randomized, blind, placebo‐controlled trial was performed with patients with chronic pressure ulcers. Doses of interleukin‐1β of .01 µg, .10 µg, and 1.0 µg per square centimeter did not show acceleration of healing of the pressure ulcers. Therefore use of recombinant human interleukin‐1β in this study was safe but, at the dose levels tested, did not result in improvement in the healing ratio.