Mallinckrodt has enrolled the first patient in a Phase I trial that seeks to evaluate the safety and tolerability of ExpressGraft-C9T1 skin tissue in the treatment of diabetic foot ulcers (DFUs).
ExpressGraft-C9T1 is a genetically engineered human skin substitute under development that expresses elevated levels of the human cathelicidin host defence peptide.
The prospective, open-label, Phase I study is entitled ‘ExpressGraft-C9T1 Skin Tissue as a Treatment of Diabetic Foot Ulcers’, and expects to enrol up to six subjects with a confirmed diagnosis of diabetes and who have foot ulcers.
As part of the trial, each patient will be given a single application of ExpressGraft-C9T1 skin tissue on a single identified study DFU following a ten to 14 day run-in period.
Patients who require additional treatment will receive protocol-defined dressings as necessary.
Enrolment for the study is expected to be conducted in stages with a minimum of one week between each subject.
The trial will assess the safety and tolerability of ExpressGraft-C9T1 skin tissue by monitoring adverse events, clinically significant vital signs, blood chemistry, safety laboratory values. In addition, there will also be immunological testing, and incidence of treatment site infection throughout the 12-month study period.
The ExpressGraft-C9T1 skin tissue study lead investigator Thomas Serena said: “Diabetic foot ulcers and resulting complications can be physically debilitating and lead to emotionally devastating problems in this population.
“This research may help expand options and further our understanding of diabetic complications related to DFUs.”
A research has suggested that more than 22 million people were diagnosed with diabetes in the US in 2012, accounting for 7.7% of the population.
Patients with diabetes are reportedly developing complications of DFUs, which is considered to be the main cause of lower extremity amputations.