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Excerpt
Encelle has also initiated a controlled pilot clinical study of E-Matrix for treatment of diabetic foot ulcers at 10 US sites. This study will assess E-Matrix treatment versus standard wound care among 60 patients with chronic ulcers. Smith & Nephew, Largo, FL, which is providing funds for the study, has a worldwide license for E-Matrix in the treatment of cutaneous wounds.
Topical recombinant human lactoferrin (rhLF) gel (Agennix, Inc, Houston, TX) consistently increased the rate and incidence of wound closure relative to placebo and to the approved drug therapy (rh-PDGF-BB, becaplermin) in mice with full-thickness wounds. Both healthy mice and diabetic mice with impaired healing were used in the trial.
RhLF has been used in humans as well and it appears to be safe and well tolerated: More than 300 people have used rhLF, topically and orally, without serious drug-related adverse events. A blinded, multicenter Phase I/II clinical trial will evaluate the safety and efficacy of topical rhLF in patients with diabetic foot ulcers. After the initial dose escalation phase, patients will be randomized between placebo and 2 doses of rhLF. Results from the efficacy phase of the trial are expected in early 2004.
