A Multi-Center, Single-Blinded Randomized Controlled Clinical Trial Evaluating the Effect of Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers

Speaker: David G. Armstrong, DPM, MD, PhD

Introduction: Diabetic foot complications continue to plague patients, providers and health systems around the world. In particular, the lifetime incid-ence of developing a diabetic foot ulcer (DFU) is 34%, and between 9.1-26.1 million people with diabetes develop a foot ulcer every year.1 Thus, there is a significant need to explore advanced wound care modalities that can enhance wound healing in this complex population and potentially save limbs and lives.

Bioactive glass materials are biocompatible water-soluble materials that release their constituent ions when immersed in body fluids. Although the focus of these products has been the development of a scaffold material for bone tissue engineering, researchers have been intrigued by their potential to heal wounds through improving angiogenesis,2 increasing metabolic activity and cell proliferation,3 and serving as antimicrobial agents.4,5 All of these processes are essential components in the healing of chronic wounds.

Mirragen Advanced Wound Matrix (BBGFM) is a novel, borate-based, bioactive glass nanofiber (ETS Wound Care; Rolla, Missouri) with a target composition of

53B2O3–6Na2O–12K2O–5MgO–20CaO–4P2O5 wt%. Borate-based bioactive glasses have been formulated to degrade in the wound over a period of days or weeks. The rate of degradation depends in part on the wound exudate and thus can be washed out or degraded as the wound heals.

Methods: In this parallel, two-group, single-blind randomized controlled trial, forty patients with chronic, full-thickness, non-infected, non-ischemic DFUs (Wagner 1) were randomized to either standard of care (SOC) alone or BBGFM + SOC and treated for a period of 12 weeks. Both groups received SOC, including glucose monitoring, weekly debridements (when needed) and application of a collagen alginate primary dressing (Fibracol; 3M corporation Minneapolis, MN) topped with a padded three-layer dressing (Dynaflex, 3M Corporation, Minneapolis, MN) or equivalent, and an offloading device. In addition, patients in the active treatment group received weekly application of the BBGFM dressing. Because BBGFM is completely bioabsorbable and is eventually absorbed at the wound site, only loose sections from prior applications were removed at subsequent visits during debridement.

For more information about MIRRAGEN® and ETS click here.

Read the Transcript:

I am David Armstrong, Professor of Surgery and Director of the Keck School of Medicine, Southwestern Academic Limb Salvage Alliance at the University of Southern California, beautiful, sunny, Southern California, or even when it's not sunny, it's sunny. And I'm joined by my superb co-authors on this study who you see, with whom this study would just not have been possible. And I'm really excited to talk about the results of this 40 patient randomized control trial of a glass matrix that I think we did not know how it was going to perform at first, but I think now is raising enthusiasm.

You know, every second now around the world, someone with diabetes develops a diabetic foot ulcer. About half of these wounds will get infected. About 20% of those infections will end up in a hospital, which now is why we see an amputation every 20 seconds around the world. And this problem, unfortunately, is increasing in many parts of the world, not decreasing. And even for places where infections and amputations are decreasing, the rate of ulcers is increasing. So this is a massive public health problem and this is why we're together to try to affect change here. So any kind of product that we have that could help us along in that battle is welcome, which is why we wanted to interrogate our initial clinical enthusiasm around this product.

In this study, we randomized people either to receive this matrix or standard clinical care, which consisted of a Fibracol dressing. Patients had standardized debridement and offloading and were followed for 12 weeks until healing. And we wanted to look not only at the percentage of people healed in the 12 weeks, but also the percentage wound area reductions. And we also measured, interestingly, neuropathy utilizing Semmes Weinstein in a specified manner at various points throughout the procedure to evaluate sensation. And we'll talk about that in a minute as well. But our primary aims were percentage healing at 12 weeks and secondary aims included percentage wound area reduction and neuropathy.

And the results of the study were surprising. We saw 70, 7-0% wound healing in the active group compared to only 25% in the control group at 12 weeks. We also saw even more percentage wound area reduction in the active group compared to the control group in this study. So significant signals there. We also saw what appeared to be a signal suggesting improved sensation in this study. Why that is, we don't know. And I think that bears further interrogation as we move forward.

If we look at the rate of adverse events, there were no adverse events recorded in the active group and 25% in the control group. Our initial clinical experience with this glass fiber matrix has been, I think, has exceeded our expectations. And I must say we were initially relatively skeptical going in with this product because of the form factor and because we hadn't had experience with this sort of form factor in the past. But actually for not only superficial wounds, but actually maybe even deeper wounds, this may show I think, significant promise in helping to either calm down the wound matrix and mitigate inflammation and also possibly also stimulate healing. We'll see. But our personal experience with this has, I think, exceeded our expectations initially. And I think we look forward to further efforts that are going to help us identify who's going to benefit from this product because these early data are surprising, and let me say, surprising in a good way.