Reece Pharmaceuticals has onboarded outpatient nurses from healthcare provider Ascott, an IQVIA Company, to support its R327 diabetic foot infection (DFI) clinical trial.
Claimed to be the largest DFI study underway in Australia at this time, the prospective, interventional, Phase I/II clinical trial will evaluate the safety and efficacy of REECE 327 (R327) as broad spectrum, topical anti-infective treatment for patients with mild skin and soft tissue diabetic foot infections.
In the US, 14-24% of diabetic patients who develop a foot ulcer will need an amputation, and foot ulceration precedes 85% of amputations related to diabetes.
Treatment of diabetic foot diseases costs anywhere between $9bn and $13bn annually in the US.
The in-home (outpatient) nurses are particularly trained in R327 DFI treatment protocols under the Australian guidelines.
As per the R327 dosing protocols, Ascott nurses will offer and replicate the level of care that patients would get at on-site clinical trial visits, thereby raising the probability of protocol adherence and completion of dosing.
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Furthermore, the in-home nurses will follow the Australian and international clinical trial regulatory requirements and undertake services including gathering vital signs, carrying out basic wound evaluation and cleaning, administering R327 as a topical agent, and providing concomitant medication and monitoring and recording of adverse events.
Ascott has more than 22 years of clinical experience and expertise across the pharmaceutical and healthcare industry, including 12 years of clinical experience supporting in-home clinical trials.
It is currently supporting 29 active clinical trials in Australia and New Zealand in the home.
Ascott’s approximately 300 nurses interact with over 25,000 patients annually.
Recce Pharmaceuticals CEO James Graham said, “We are thrilled to further strengthen our Phase I/II clinical trial with the support of Ascott. As the global search for an effective treatment for Diabetic Foot Infections continues, Recce is leading the way by conducting Australia’s largest DFI study. The Company continues to address unmet medical needs through our portfolio of clinical programmes.”