Tissue Regenix Group will publish for the first time retrospective analysis on wound care product DermaPure providing “real world” evidence of its use in clinical practice.
“Retrospective Observational Analysis of the Use of an Architecturally Unique Dermal Regeneration Template (DermaPure) for the Treatment of Hard-to-Heal Wounds” by Kimmel, Howard, Gittleman, Haley, is now available online and will feature in the International Wound Journal, the first time a U.S. physician has published a DermaPure study in a peer reviewed journal.
The data which has been collated from 37 patients across 29 treatment centers, mainly focuses on the use of DermaPure in the treatment of chronic wounds such as diabetic foot ulcers (DFU) 37.8 percent and venous leg ulcers (VLU) 18.9 percent, with the remaining patients being treated for either traumatic or surgical wounds.
At the time of application, the average wound size was 12.88cm2 and had been present for 56 weeks. The end point of the study was considered to be once complete closure was established, something which was achieved with one application of DermaPure in an average time of 10.58 weeks.
The retrospective data analyzed proved to be consistent with what has been observed in published studies previously undertaken by NHSBT in the U.K. and showed complete healing for:
- DFU’s – 52 percent at 4 weeks: 73 percent at 8 weeks; 85 percent at 12 weeks; average time to heal 8.21 weeks
- VLU’s – 49 percent at 4 weeks; 70 percent at 8 weeks; 81 percent at 12 weeks; average time to heal 11.29 weeks
When compared with two other retrospective trials of acellular dermis used to treat DFUs DermaPure was proven to heal more effectively with fewer applications.
Alongside this, a study undertaken at the University of Manchester looking into gene expression and the effect that this has on healing chronic wounds has been published in Wound Repair and Regeneration.
The findings of this research, led by Dr. Ardeshir Bayat, is of particular importance as optimal wound healing is dependent upon appropriate gene expression. The outcome of this study has confirmed that by applying DermaPure to a chronic wound, such as a DFU, post debridement, the wound is converted to an acute wound, allowing the body to progress naturally through the wound healing cycle. Chronic wounds that did not receive this treatment had different gene expression and remained unable to advance appropriately through the healing process. Thus, proving a treatment such as DermaPure to have a significant advantage when treating patients suffering with chronic wounds, such as DFU’s, where the amputation rate can be as high as 15 percent.
Greg Bila, president, Tissue Regenix Wound Care Inc. said: “The publication of this clinical data is key in highlighting the problems physicians face when treating chronic wounds, and how regenerative treatments such as DermaPure address, and potentially revolutionize, the outlook for these patients. Many times products illustrate outcomes in the study environment that are seldom seen in the real world clinical environment. However, we now have two substantive pieces of research that illustrate the effectiveness of Tissue Regenix dCELL technology in the treatment of chronic and acute wounds, and demonstrates the potential effectiveness of this technology in other areas of healthcare.”
A full copy of the peer reviewed paper is available here.
About Tissue Regenix
Tissue Regenix is a leading medical devices company in the field of regenerative medicine. The company’s patented decellularization (dCELL) technology removes DNA and other cellular material from animal and human tissue leaving an acellular tissue scaffold which is not rejected by the patient’s body which can then be used to repair diseased or worn out body parts. The potential applications of this process are diverse and address many critical clinical needs such as vascular disease, heart valve replacement and knee repair.
Tissue Regenix was formed in 2006 when it was spun-out from the University of Leeds. The company commercializes academic research conducted by our partners around the World.
In November 2012 Tissue Regenix Group plc set up a subsidiary company in the United States—Tissue Regenix Wound Care Inc., as part of its commercialization strategy for its dCELL technology platform.
(Source: Business Wire)
