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• W1972291098 abstract "Thomas Serena et al. and the EpiFix VLU Study Group have reported what appear to be very good outcomes achieved in the healing of venous leg ulcers (VLU) when treated with dehydrated human amnion/chorion membrane (dHACM) used in conjunction with standard multilayer compression.1 New approaches are badly needed as many people suffering with VLU are not healed with standard compression therapy alone. While we agree that the use of an extracellular matrix product derived from placental tissues is certainly of interest, several aspects of the study design raise concerns that we feel require the results of this study to be interpreted with caution. We offer the following considerations in the spirit of constructive criticism. Our view is that better trial designs with clear conclusions will allow those suffering with VLU to have the best chance of success with advanced therapeutic options. It is well known that between 30 and 75 % of all VLU will respond to standard compression therapy and heal.2 Those VLU that do not respond become chronic and represent the unmet medical need. A novel therapy, such as dHACM, designed to improve upon standard care (i.e., multilayer compression bandaging) should be tested in the population it is intended to benefit, namely, chronic ulcers that have failed to respond to compression. One way to accomplish this is to employ a run-in period prior to randomization where the rate of healing is monitored under compression alone. VLU that respond during this period should not be randomized, ensuring that only the nonresponsive, chronic ulcers are enrolled.3 In this study there was a requirement for ulcers to have been treated for 2 weeks with compression therapy; however, inexplicably, there were no exclusions for rapid healers. To the contrary, ulcers that had been nonhealing under 1 year of compression were excluded from the trial. It is also well known that small ulcers heal more rapidly and successfully than large ulcers. The minimum eligible ulcer size is given as 2 cm2 in the published paper, but as 5 cm2 in the clinicaltrials.gov posting (NCT01552447). The median size enrolled was 4.4 cm2 for the dHACM group and 4.1 cm2 for compression, thus half of the ulcers across the study were 4 cm2 or less and relatively easy to heal. Taken together, it would seem that the study population likely included small, rapid-healing ulcers and excluded many of the chronic ulcers that were the aim of the study. Our greatest concern lies in the choice of endpoint. The only valid endpoint recognized by the Food and Drug Administration (FDA) and other regulatory bodies is ulcer closure defined as 100% reepithelialized, without drainage and not requiring a dressing. Moreover, this closure must be confirmed at two subsequent visits, each at 2-week intervals. Instead, the authors chose the surrogate endpoint of 40% wound closure at 4 weeks. While there is some literature suggesting that this may be a good predictor of ultimate healing at 12 or 24 weeks, the same literature acknowledges that it is only correct about 70% of the time.4, 5 Taking this 70% accuracy and applying it to the 62% of ulcers achieving a 40% reduction in area by week 4 (0.62 × 0.7), an estimated 43% would have been closed at 12 weeks. As the authors did not validate this endpoint by following the patients for a full 12 weeks, this seems to be the most reasonable conclusion. The problems with this paper are not limited to the study population and the primary endpoint, but also include patient bias and inaccurate wound area measurements. Ulcer pain was a stated secondary endpoint and was assessed using the visual analog scale (VAS). While this is a standard method, it is inherently subjective and therefore susceptible to patient bias. Patients were not blind to treatment and, as noted in the paper, three patients randomized to compression alone withdrew from the study because they were unhappy with the treatment assignment, suggesting that patients viewed the control group as an inferior treatment. Ulcer area and not closure was the primary endpoint in this trial, therefore there was a critical need for accurate measurement of the ulcers. While ruler measurements may be adequate for “real world” ulcer management, digital wound measurement devices have become the standard in sponsored clinical trials. It is disappointing that area was assessed as length × width using a ruler. While we agree that dHACM is an interesting treatment that may provide a benefit for healing chronic VLU, this has not been demonstrated with any surety in the current trial. Additional studies with the appropriate patient population and appropriate endpoints are needed. Source of Funding: None. Conflicts of Interest: JED and HBS are employees of Smith & Nephew, Inc." @default.
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• W1972291098 date "2015-01-01" @default.
• W1972291098 modified "2023-09-26" @default.
• W1972291098 title "Dehydrated amnion/chorion membrane and venous leg ulcers" @default.
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• W1972291098 doi "https://doi.org/10.1111/wrr.12257" @default.
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