Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has on-boarded in-home, outpatient nurses from leading healthcare provider Ascott to support its R327 diabetic foot infection (DFI) clinical trial.
The nurses are specifically trained in R327 DFI treatment protocols as per the Australian guidelines.
RCE's Phase 1/2 clinical trial is a prospective, interventional study assessing the safety and efficacy of R327 as a broad-spectrum, topical anti-infective treatment for patients with mild skin and soft tissue diabetic foot infections.
Largest diabetic foot infection study nationally
The company understands this to be the largest DFI study underway in Australia.
In the United States, an alarming 14-24% of patients with diabetes who develop a foot ulcer will require an amputation, with foot ulceration preceding 85% of diabetes-related amputations.
Treating diabetic foot diseases in the US costs US$9-13 billion every year.
Ascott is a leading healthcare provider and its involvement broadens the treatable DFI trial patient population.
The nurses will provide and replicate the high level of care patients would receive if attending on-site clinical trial visits, increasing the probability of protocol adherence and dosing completion.
Adherence to trial standards
The nurses will follow national and international clinical trial regulatory requirements to perform services including collecting vital signs, conducting basic wound assessment and cleaning, administering R327 as a topical agent and performing concomitant medication and adverse event monitoring and recording.
Recce Pharmaceuticals CEO James Graham said: “We are thrilled to further strengthen our Phase 1/2 clinical trial with the support of Ascott.
“As the global search for an effective treatment for DFIs 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 programs.”
About Ascott
Ascott has more than 22 years of clinical experience and expertise across the pharmaceutical and healthcare industry, which includes medical devices, clinic support, nurse support, patient engagement programs and 12 years of clinical experience supporting in-home clinical trials.
Currently supporting 29 active clinical trials across Australia and New Zealand in the home, some 300 dedicated Ascott nurses interact with more than 25,000 patients per year, with the ability to implement scalable solutions to quickly meet demand.