Peer Reviewed Clinical Studies
A Retrospective Clinical Study of 188 Consecutive Patients to Examine the
of a Biologically Active Cryopreserved Human Skin Allograft (TheraSkin®) on the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
Landsman et al. Foot Ankle Spec 2011 4 (1), p. 29
A biologically active human skin allograft, currently distributed under the brand name TheraSkin®, was examined for safety and efficacy in the treatment of venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs). The objective was to determine if TheraSkin could serve as a safe and effective alternative to bioengineered skin substitutes such as Apligraf® and Dermagraft®.
The authors conducted a retrospective study of 214 consecutive patients seen at the Inova Wound Center (Mt Vernon, Virginia), with either a DFU or a VLU. After excluding patients who did not meet the study criteria, the final eligible cohort consisted of 188 subjects, with 134 VLUs and 54 DFUs.
Multivariate logistic regression was used to evaluate the relationship between baseline wound size and the proportion of healed wounds after 12 and 20 weeks from initial allograft application. The authors found that by the 12th week, DFUs closed 60.38% of the time and VLUs closed 60.77% of the time. After 20 weeks, the number of closed DFUs increased to 74.1% and the number of VLUs increased to 74.6%. The mean wound size in the DFU group was 6.2 cm2 (±11.8) and 11.8 cm2 (±22.5) in the VLU group. The mean number of TheraSkin allografts required ranged from 1 to 8, with an average of 2.03 (±1.47) at the 12-week point and an average of 3.23 (±2.77) at the 20-week point.
Multivariate logistic regression was used to calculate the odds of wound healing by week 12 and week 20 in each group. The authors also analyzed adverse events and found TheraSkin to be noncontributory to any adverse events, verifying the safety of TheraSkin in this study population. In this study, TheraSkin has been shown to be highly effective for the treatment of both VLUs and DFUs with an acceptable safety profile.
DOI: 10.1177/1938640010387417. From Harvard Medical School, Boston (ASL); Cambridge Health Alliance, Cambridge, Massachusetts (ASL); California College of Podiatric Medicine at Samuel Merritt University, Oakland, California (ASL); Beth Israel Deaconess Medical Center, Boston, Massachusetts (JC, EC); Mt Vernon Hospital, Mt Vernon, Virginia (ARL, PG, JY, AK, ED); Inova Mt Vernon Wound Healing Center, Mt Vernon, Virginia (PG, JY, AK, ED). The authors have declared a potential conflict of interest: Funding for this study was provided by LifeNet Health, Inc, Viginia Beach, VA. Dr Adam Landsman is a paid consultant for LifeNet Health and Soluble Systems. Dr Jeremy Cook and Dr Emily Cook received funding from LifeNet Health to offset the costs of statistical analysis. Dr Arnold Landsman received funding to offset the costs of travel to the study site, for the purpose of data collection.
To review the full article or for reprints of the full article contact Foot & Ankle Specialists or Soluble Systems.
A Prospective Comparison of Diabetic Foot Ulcers Treated With Either A Cryopreserved Skin Allograft or a Bioengineered Skin Substitute
Lawrence DiDomenica, DPM FACFAS1; Kenneth J. Emch, DPM, FACFAS1; Arnold R. Landsman, DPM2; Adam Landsman, DPM, PhD, FACFAS2,3
WOUNDS 2011; 23(7): 184-189
It was hypothesized that the rate of wound closure and the number of grafts required will be the same when treating diabetic foot ulcers with TheraSkin®, a cryopreserved split-thickness skin allograft (SSA), as compared to Apligraf®, a bioengineered skin substitute (BSS).
A prospective study using sequentially enrolled patients seen in a large podiatric practice encompassing multiple locations was conducted. Patients were sequentially enrolled and treated with either BSS or SSA. All other factors of treatment were standardized across the patient population.
Data Analysis included an analysis of co-factors in each group in order to determine if anything else may have influenced the outcomes. Data from 17 wounds (16 patients) treated with BSS and 12 wounds treated with SSA were analyzed. The average wound sizes were comparable, as was the average number of applications utilized. These data revealed that 41.3% of the wounds treated with BSS closed within 12 weeks, as compared to 66.7% of the wounds treated with SSA. At 20 weeks, 47.1% of the wounds in the BSS group closed, while 66.7% of the SAA wounds closed. There were a comparable number of adverse events in each group, none of which were a direct result of the biologic material being used.
SSA resulted in higher percentage of wounds closing after 12 and 20 weeks, as compared to wounds treated with BSS. There are no adverse events noted that were directly related to either graft material.
To review the full article or for reprints of the full article contact WOUNDS or Soluble Systems.