Regenerative technologies firm StimLabs has started patient enrolment in a clinical trial being conducted to test the safety and efficacy of its Revita product to treat diabetic foot ulcers (DFUs).
Designed as a wound covering, Revita is a placental membrane allograft. It is said to be the first of its kind to capture the complete intact membrane in a shelf-stable format.
The product is processed using Clearify, which is claimed to preserve all biologic tissue layers and retain the natural barrier membrane’s physiologic 3D structure.
During the multi-centre, randomised, controlled trial, Revita’s efficacy for improving wound closure rates in DFUs will be compared to existing standards of wound care treatment.
The study, which will be carried out at primary institutions/centres in the US, will also assess mean closure time with placental membrane allograft.
In addition, the trial will measure the proportion of patients with a 50% reduction in ulcer volume by day 28, and the percentage of patients healed in the open-label phase.
A total of 40 patients are set to be enrolled in the trial and will receive Revita or current standards of wound care treatment.
StimLabs founder and CEO John Daniel said: “As the first intact, shelf-stable placental membrane, Revita has set a new standard for amniotic tissue products, and the clinical outcomes we’ve seen across the country have been exceptional.
“We’re also excited to leverage the power of Tissue Analytics for this study. This unique platform uses machine learning to more accurately evaluate wound characteristics, increasing the accuracy and integrity of our outcomes data.”
Diabetes can have a lot of effects on a patients body and can particularly affect blood flow in the legs and feet. Blood flow problems can mean that any wounds on the feet will not heal quickly or will not heal at all.
Of the total patients suffering from DFUs, up to 24% require amputation, and these patients have a survival rate of approximately 50%.
DFU care costs around $9bn to $13bn per year, becoming a major financial burden.
Additional reporting by Charlotte Edwards.