Amnion and chorion allografts have shown great promise in healing diabetic foot ulcers (DFUs). Results from an interim analysis of 40 patients have demonstrated the accelerated healing ability of a novel aseptically processed, dehydrated human amnion and chorion allograft (dHACA). The goal of this study was to report on the full trial results of 80 patients where dHACA was compared with standard of care (SOC) in achieving wound closure in non-healing DFUs. After a 2-week screening period, during which patients with DFUs were unsuccessfully treated with SOC, patients were randomised to either SOC alone or SOC with dHACA applied weekly for up to 12 weeks. At 12 weeks, 85% (34/40) of the dHACA-treated DFUs healed, compared with 33% (13/40) treated with SOC alone. Mean time to heal within 12 weeks was significantly faster for the dHACA- treated group compared with SOC, 37 days vs 67 days in the SOC group (P = .000006). Mean number of grafts used per healed wound during the same time period was 4.0, and mean cost of the tissue to heal a DFU was $1771. The authors concluded that aseptically processed dHACA heals DFUs significantly faster than SOC at 12 weeks.
In this tightly controlled 6-week study in which no patients were lost to follow-up, Bensal HP seems to be an effective treatment for properly treated diabetic ulcers, outperforming an identical control group whose only difference was SSC as a medication.
Analgesic medications are distributed to a variety of receptors within the central nervous system. Activity at these receptors (mu 1, mu, sigma, delta, kappa) results in both the beneficial pain-relieving effects of analgesics as well as undesirable side effects. The mixed agonist-antagonist class of analgesics offers the potential benefit of greater receptor site selectivity while diminishing the incidence of adverse sequelae, such as respiratory depression. Traditionally, it has been suggested that mixed agonist-antagonist medications may be associated with decreased analgesic effectiveness. However, newer agents of this mixed class may result in effective analgesia while diminishing the incidence of side effects.
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