Amniotic membrane wound grafts improve healing rates for non-healing venous leg ulcers

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Thomas Serena
Thomas Serena

It has been found that the application of dehydrated human amnion and chorion allografts (dHACA) results in a better venous leg ulcer (VLU) healing rate than the use of standard multilayer compression therapy, following a randomised controlled study comparing the two treatment regimes. Displayed in a poster presentation at the Symposium on Advanced Wound Care Fall meeting (SAWC Fall 2019; 12–14 October, Las Vegas, USA), the trial responds to the “significant clinical, humanistic and economic burden” created by VLUs.

According to the research, conducted by principal investigator Thomas Serena (Cambridge, Massachusetts, USA) et al, “millions of Americans are afflicted with painful, open, draining sores on their lower extremities,” many of which have a venous aetiology and are incredibly difficult to heal. Although some patients require weeks or months to recover, a significant number of those suffering with VLUs take years to heal or, in some cases, even face amputation as a result of their wounds.

In terms of costs, the poster presentation highlighted that “the consequence of long term disability has been estimated at 4.6 million work days lost per year and a cost to the healthcare system of up to US$2.5 million annually in the United States.” Moreover, current VLU rates are reportedly as low as 30% in 24 weeks, emphasising the need for new, advanced therapies that can achieve better results.

Recent clinical data has shown that dHACA, which feature endogenous growth factors to facilitate wound healing, are more effective than other bioengineered skin substitutes in the treatment of diabetic wounds, prompting a new prospective, multi-centre trial to “compare the proportion of ulcers healed completely with the use of dHACA vs. standard of care patients with venous leg ulcers”.

Conducted in eight outpatient wound centres, this was the first study to evaluate the efficacy of dHACA in VLU treatment using weekly and biweekly application regimens against multilayer compression bandaging.

As part of the trial, patients with non-healing VLUs treated with standard of care—consisting of appropriate debridement, a primary absorptive dressing and multilayer compression—after a two-week screening period were randomised to either a standard of care group (20 patients), or a cohort receiving “wound-size specific” dHACA plus multilayer compression applied weekly (20 patients) for up to 12 weeks. Furthermore, the primary endpoint of this clinical trial was the percentage of patients healed at 12 weeks (defined as complete epithelialisation).

At the conclusion of the study, it was discovered that both weekly and biweekly application of dHACA resulted in a statistically significant improvement in healing rates for VLUs, when compared to standard wound therapy. For those patients who received standard of care only, 30% (six out of 20 patients) healed in 12 weeks, with the mean percentage wound area reduction just 57.8%. Alternatively, 75% of patients (15 out of 20) who were treated with dHACA weekly and biweekly healed within 12 weeks, with a mean percentage wound area reduction of 80.7% (p=0.012).

The findings of this study underline that the use of dHACA results in a greater percentage of patients healed within 12 weeks than multilayer compression therapy, improving the healing trajectories of patients and benefitting those who had previously failed to heal under standard of care.

Speaking to iWounds News about the investigation, Serena commented: “The dedicated investigators and research coordinators in the SerenaGroup Research Foundation make publications such as this possible. Our cooperative group of clinical research sites conducts roughly a dozen clinical trials per year publishing 12-15 manuscripts. We are advancing the science of wound healing. We welcome interested physicians and research sites to join the effort.”

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