StimLabs, a regenerative technology company announced that the first patient has been enrolled in the company’s clinical trial assessing the safety and efficacy of Revita® as a wound covering for diabetic foot ulcers.
The multi-center randomized, controlled study will evaluate the efficacy of Revita in improving wound closure rates in diabetic foot ulcers as compared to current standards of wound care treatment.
Revita is the first amniotic allograft to capture the complete, intact membrane in a shelf-stable format.
“We are thrilled to commence patient enrollment in this key study,” said John Daniel, Founder, and CEO of StimLabs. “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.”
Daniel says this study will build on the evidence the company has collected to date, and validate the feedback they have received.
“We’re also excited to leverage the power of Tissue Analytics for this study,” Daniel explains, “this unique platform uses machine learning to more accurately evaluate wound characteristics, increasing the accuracy and integrity of our outcomes data.”
Diabetes is on the rise and affects approximately 30 million people in the United States.
As many as 25% of patients with diabetes will develop diabetic foot ulcers within their lifetime.
Of that total, up to 24% of those individuals’ condition will lead to an amputation. Amputated patients have around a 50% survival rate.
The study is a randomized, comparative, controlled trial that will evaluate the efficacy of Revita full thickness placental allograft in improving wound closure rates and mean closure time in diabetic foot ulcers (DFUs) as compared to current standards of wound care treatment.
The trial will be conducted at primary institutions/centers in the United States. This trial focuses on patients who suffer from type 1 or 2 diabetes with diabetic foot ulcer(s) greater than 1 cm2 and less than 25 cm2 for longer than 4 weeks prior to enrollment.
The target enrollment is 40 patients, and patients will be randomized to either the Treatment or Control group.
Additional study outcome measures include time to closure, number of patients with 50% ulcer volume decrease by day 28, and percent healed in the open-label phase.
For more information, visit www.stimlabs.com.
- StimLabs Announces Enrollment of First Patient in Trial Investigating the Efficacy of Full-Thickness Human Placental Graft Revita® in Diabetic Foot Ulcers. (2019, Feb. 1), PR Newswire. Retrieved: https://prnmedia.prnewswire.com/news-releases/stimlabs-announces-enrollment-of-first-patient-in-trial-investigating-the-efficacy-of-full-thickness-human-placental-graft-revita-in-diabetic-foot-ulcers-300787844.html