Case Study

DFU

Treating Infected Diabetic Foot Ulcers (DFU)

The Challenge

A pharmaceutical company launched a Phase I/II study on a novel drug for treating infected diabetic foot ulcers (DFU). After one year of recruitment, only 12 subjects of the 26 needed subjects were enrolled. As the recruitment deadline was quickly approaching, the study faced several recruitment challenges: the active site was a hospital and during the COVID pandemic potential subjects were justifiably fearful of hospitals. Patients being treated for DFU at the hospital often had ulcers that were too advanced to meet study requirements. The ulcer needed to be infected with specific types of bacteria. nRollmed was brought on to expedite recruitment of the final hard-to-find patients.

Customized and Collaborative Approach

nRollmed designed an awareness campaign using print and digital advertising. Leads were pre-screened to ensure only highly qualified patients were referred to the sites. Once at the site, several additional barriers to participation became apparent. Compensation for patients’ travel was not well organized, especial for patients traveling long distances. nRollmed found a cab service that established a contract with the sites so that patients didn’t have to pay out of pocket. nRollmed implemented weekly phone calls to study coordinators and helping schedule patients’ visits to improve site efficiency. The doctors’ unpredictable schedules made scheduling appointments difficult. To reduce the need for onsite assessment, nRollmed asked patients to send a picture of their ulcer to the study team. Elderly patients were assisted with this process by the nRollmed team.

The nRollmed Method

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Results

nRollmed worked within the sponsor’s budget and provided 260 leads, exceeding the predicted number by 110. After pre-screening, 70 patients were referred to the sites, of which 6 signed consent. Four of these were randomized with a 33% screen fail rate, improving on the sponsor’s expected screen fail rate of 60-75%.

In the time that nRollmed was active, 7 patients were randomized. nRollmed’s referrals made up more than 50% of the enrollments in that time period.

The study, which had been recruiting on average one patient a month for the previous year, increased to enrolling three patients a month. This was due to nRollmed’s persistence in increasing site attention and commitment to the study, and by nRollmed’s work to widen the patient pool.

260

leads in 2 months

signed consent

the monthly recruitment rate

nRollmed’s referrals equal more than 50% of enrollments

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