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StimLabs enrols first diabetic patient under clinical trial of Revita for diabetic foot ulcers (DFUs).

M2 PHARMA-February 4, 2019-StimLabs enrols first diabetic patient under clinical trial of Revita for diabetic foot ulcers (DFUs)

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Regenerative company StimLabs said on Friday that the first diabetic patient has been admitted under the clinical trial of Revita for diabetic foot ulcers (DFUs).

As many as 25% of patients with diabetes will develop a DFU 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. In addition to these outcomes, DFUs are also a major financial burden on the health care system.

According to the company, Revita is the first amniotic allograft to capture the complete, intact membrane in a shelf-stable format. It is the first placental membrane allograft to capture the complete intact membrane in a shelf-stable format. It is uniquely processed using the patent-pending Clearify process to preserve all three layers of the biologic tissue and maintain the physiologic 3D architecture of the natural barrier membrane.

This multi-centre randomised, controlled US study will evaluate the efficacy of Revita full thickness placental allograft in improving wound closure rates and mean closure time in diabetic foot ulcers (DFUs) in 40 patients as compared to current standards of wound care treatment.The trial focuses on patients who suffer from Type 1 or 2 Diabetes with diabetic foot ulcer(s) greater than 1cm2 and less than 25 cm2. 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.

Revita allografts are aseptically processed and terminally sterilized according to US FDA current Good Tissue Practice requirements and the American Association of Tissue Banks (AATB) Standards for Tissue Banking (14th ed.).

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Publication:M2 Pharma
Date:Feb 4, 2019
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