Osiris Therapeutics, Inc. Announces Peer-Reviewed Publication Comparing the Efficacy of Viable Cryopreserved Placental Membranes to Human Fibroblast-Derived Dermal Substitute in the Treatment of Chronic Diabetic Foot Ulcers (DFUs) in a Multicenter Randomi
Dermagraft® (1) is a bioengineered human fibroblast-derived dermal substitute product that has been on the U.S. market for more than 15 years (2, 3). Grafix® is a cryopreserved placental tissue allograft that has been developed using a proprietary cryopreservation method. This method allows the retention of intact matrix, growth factors and cells native to placental tissue. Prior clinical studies have shown the safety and efficacy of both Grafix and Dermagraft when used in the treatment for chronic DFUs in their respective trials (4, 5). The study’s objective was to compare clinical outcomes and product cost between Grafix and Dermagraft as an adjunct to standard of care (SOC) in the treatment of chronic DFUs in a prospective, multicenter, single-blind study.
The study’s objective was to compare clinical outcomes and product cost between Grafix and Dermagraft as an adjunct to standard of care (SOC) in the treatment of chronic DFUs in a non-inferiority prospective, multicenter, single-blind study. Sixty two patients were evaluable in the per protocol (PP) population: 31 Grafix patients and 31 Dermagraft patients. There were no significant differences between treatment cohorts with an exception of longer wound duration and more plantar wound locations for the Grafix group. The average wound size was 7.12 cm2 in the Grafix group and 5.70 cm2 (p=0.732) in the Dermagraft group. Both patient cohorts had noteworthy comorbidities, such as heart disease (92.1% of Grafix patients and 94.6% of Dermagraft patients) and prior amputations (55.5% of Grafix patients and 54.1% of Dermagraft patients).
Key clinical outcomes include:
- The study met its primary endpoint: Grafix was not inferior to Dermagraft for the proportion of patients achieving complete wound closure (48.4% of Grafix patients and 38.7% of Dermagraft patients, a non-inferiority criterion of the lower limit of 90% confidential interval greater than -15% was met) when the established-for-Dermagraft-treatment- regimen of up to 8 weekly application was used for both skin substitutes.
- For a subset of patients with typical DFUs (≤ 5 cm2), closure at the end of treatment was achieved in 81.3% (13/16) of Grafix patients, compared to 37.5% (6/16) of Dermagraft patients (p=0.0118).
- For DFUs of less or equal to 5 cm2, mean per-patient product cost for Grafix patients was
$3,846compared to $7,968for Dermagraft patients (p < 0.0001).
“With growing number of wound care products and development of new technologies, comparative research in prospective randomized studies has tremendous value,” said Dr.
- Dermagraft® is a registered trademark of
Organogenesis, Inc.( Canton, MA).
- Naughton G, Mansbridge J, Gentzkow G. A metabolically active human dermal replacement for the treatment of diabetic foot ulcers. Arti Organs 1997;21:1203-10.
- Hart CE, Loewen-Rodriguez A, Lessem J. Dermagraft: use in the treatment of chronic wounds. Adv Wound Care (New Rochelle) 2012;1:138-41.
- Lavery LA, Fulmer J, Shebetka KA, et al. The efficacy and safety of Grafix ® for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial. Int Wound J. 2014;11:554-60.
- Marston WA, Hanft J, Norwood P, Pollak R;
Dermagraft Diabetic Foot Ulcer Study Group. The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial. Diabetes Care 2003;26:1701-05.
Grafix is a cryopreserved placental membrane that retains the extracellular matrix, growth factors, endogenous cells, including neonatal mesenchymal stem cells, and fibroblasts of the native tissue, all of which are beneficial in supporting natural wound repair. The membrane is a flexible and conforming wound cover designed for direct application to hard-to-treat acute and chronic wounds, including but not limited to diabetic foot ulcers, venous leg ulcers and thermal burns.
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Source: Osiris Therapeutics, Inc.