Search

Diabetes mellitus affects hundreds of millions of people worldwide, each of which have up to a 25% risk of developing a diabetic foot ulcer (DFU) during their lifetime. With poor DFU healing rates using standard of care, advanced treatments are introduced to attempt to close the wound. The objective of this preliminary clinical evaluation was to evaluate lower extremity ulcers treated with a novel bioengineered wound product (BWP). The BWP, a solid absorbable and conformable sheet composed of gelatin, Manuka honey, and hydroxyapatite, was applied on 12 patients with lower extremity ulcers. The patients in this evaluation spanned across 4 sites and had complicated medical histories, including little to no progression of healing with standard of care or treatment with other biomaterials. The ulcers were treated with debridement, BWP placement, dressing, appropriate compression, and offloading as necessary. Weekly follow-up visits were recommended for evaluation, debridement, and BWP reapplication. Nine patients had the BWP applied to aid in full closure. These patients achieved 100% closure within 8 weeks, with a mean closure time of 4.1 weeks. At 4 weeks, the mean percent wound closure was 94%. Three patients had the BWP applied to aid in achieving a healthy wound bed for continued treatment (eg, splitthickness skin graft) and to cover (epithelialization over) an exposed tendon. In all 12 cases, no treatment site infections were observed. The results and observations from this preliminary clinical evaluation suggest that the BWP supports rapid wound closure, a predictor of complete healing for DFUs. [ABSTRACT FROM AUTHOR]

Background: Venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs) are examples of chronic wounds that pose an ongoing health care challenge. Despite significant progress in managing such wounds, challenges persist that require innovative solutions. Cellular, acellular, and matrix-like products (CAMPs) are advanced therapies designed to facilitate chronic wound healing. Polylactic acid (PLA) is a synthetic material used in alloplastic CAMPs that has shown promise in the management of burns and traumatic injuries., Objective: To retrospectively assess the effect of PLA in promoting chronic wound healing compared with 2 other well-established CAMPs., Materials and Methods: This retrospective chart review, which was conducted in 3 high-volume wound care clinics, aimed to compare the efficacy of 2 advanced wound care products vs a PLA alloplastic CAMP in promoting DFU and VLU closure. The study included 131 wounds treated with a non-CAMP collagen dressing, fish skin grafts (FSGs), or PLA matrices. Inclusion criteria included single Wagner grade 1 or 2 DFUs or Clinical-Etiology-Anatomy-Pathophysiology classification score C6 VLUs, present for at least 12 to 52 weeks, and measuring between 1 cm² and 20 cm². Patients received weekly treatments with 1 of 3 CAMPs, along with standard care. The primary outcome was time to achieve full healing, and the secondary outcome was the proportion of ulcers healed at 12 weeks., Results: The PLA alloplastic CAMP demonstrated superior outcomes, with a 50% and 20% reduction in time to heal DFUs compared with collagen dressings and FSG, respectively (P < .001). For VLUs, PLA exhibited even more impressive results, achieving 95% and 40% reduction compared with collagen and FSG, respectively (P < .001). PLA allografts displayed a 55% higher rate of full healing by 12 weeks compared with collagen dressings, and a 26% higher rate compared with FSG (P < .001)., Conclusion: This study highlights the unique attributes of PLA for achieving wound closure. PLA-based alloplastic CAMPs are promising treatments, offering rapid healing, increased closure rates, and multifaceted benefits for wound healing.

Introduction: CAMPs are used for treating refractory DFUs where other treatments have failed. PLA is a CAMP that has demonstrated effectiveness in promoting healing in burns and acute wounds., Objective: A single-center, prospective, randomized controlled trial comparing PLA-guided closure matrices versus collagen dressings was conducted to assess healing of Wagner grades 1 and 2 DFUs., Materials and Methods: A total of 30 participants were randomized to receive weekly debridement, wound care, and DFU offloading plus either PLA or collagen CAMPs. The primary outcome was the time to achieve full healing, and the secondary outcome was the proportion of ulcers healed at 12 weeks., Results: The median time to achieve full healing was 9.3 ± 2.9 weeks in the PLA group versus 14.8 ± 8.1 weeks in the collagen group (P = .021), representing a 44% reduction in the time to heal. Furthermore, by 12 weeks, 80% of the PLA-treated ulcers were healed compared to only 33% in the collagen group (P = .025)., Conclusion: The results of this study show PLA matrices induce a potent healing response that leads to reduced healing time and an increased OR for achieving healing by 12 weeks.

Introduction: DFUs remain a cause of significant morbidity., Objective: This is the third of 3 planned articles reporting on a prospective, multicenter, randomized controlled trial evaluating the use of omega-3-rich acellular FSG compared with CAT in the management of DFUs., Materials and Methods: A total of 102 patients with a DFU (n = 51 FSG, n = 51 CAT) participated in the trial as ITT candidates, with 77 of those patients included in the PP analysis (n = 43 FSG, n = 34 CAT). Six months after treatment, patients with healed ulcers were followed up for ulcer recurrence. A cost analysis model was applied in both treatment groups., Results: The proportion of closed wounds at 12 weeks was compared, as were the secondary outcomes of healing rate and mean PAR. Diabetic foot wounds treated with FSG were significantly more likely to achieve closure than those managed with CAT (ITT: 56.9% vs 31.4%; P =.0163). The mean PAR at 12 weeks was 86.3% for FSG vs 64.0% for CAT (P =.0282)., Conclusions: Treatment of DFUs with FSG resulted in significantly more wounds healed and an annualized cost savings of $2818 compared with CAT.

Objective: This is the second of 3 planned articles reporting on a prospective, multicenter, randomized controlled trial assessing the efficacy of fish skin graft in the management of diabetic foot ulcers in comparison with the standard of care (collagen alginate dressing)., Materials and Methods: The primary end point of this prospective randomized trial is the number of closed wounds at 12 weeks., Results: As of the time of this writing, 94 patients had completed the protocol. At 12-week follow-up, healing was achieved in 63.0% of index ulcers (29 of 46 patients) in the acellular fish skin graft group compared with 31.3% in the control group (15 of 48 patients) (P =.0036). In both groups, the mean time to healing was 7 weeks. The median number of applications of the fish skin graft to achieve healing was 6., Conclusion: A clinically and statistically significant difference in healing was observed between patients treated with acellular fish skin graft and those treated with a collagen alginate dressing. The data support the completion of this prospective randomized trial.

Normal wound healing is accomplished through a series of well-coordinated, progressive events with overlapping phases. Chronic wounds are described as not progressing to healing or not being responsive to management in a timely manner. A consensus panel of multidisciplinary wound care professionals was assembled to (1) educate wound care practitioners by identifying key principles of the basic science of chronic wound pathophysiology, highlighting the impact of metalloproteinases and biofilms, as well as the role of the extracellular matrix; and (2) equip practitioners with a systematic strategy for the prevention and healing of acute injuries and chronic wounds based upon scientific evidence and the panel members' expertise. An algorithm is presented that represents a shift in strategy to proactive and early aggressive wound management. With proactive management, adjunct therapies are applied preemptively to acute injuries to reduce wound duration and risk of chronicity. For existing chronic wounds, early aggressive wound management is employed to break the pathophysiology cycle and drive wounds toward healing. Reducing bioburden through debridement and bioburden management and using collagen dressings to balance protease activity prior to the use of advanced modalities may enhance their effectiveness. This early aggressive wound management strategy is recommended for patients at high risk for chronic wound development at a minimum. In their own practices, the panel members apply this systematic strategy for all patients presenting with acute injuries or chronic wounds.

The objective of this article is to describe the results of a comparative porcine study that evaluated the effectiveness of a gentian violet and methylene blue (GV/MB) polyvinyl alcohol (PVA) antibacterial foam dressing in debriding eschar. The authors performed an in vivo, preclinical study on eschar-covered porcine wounds. Two clinical case studies are also included. Test products, GV/MB antibacterial foam dressing, collagenase ointment, collagenase ointment plus GV/MB antibacterial foam dressing, medical-grade honey, and moist gauze dressing (control), were applied to porcine wounds using a split-back study design. The percent of eschar removal and wound closure were measured and recorded at time points up to 14 days. Statistically significant reduction in eschar was observed with GV/MB dressing and with GV/MB dressing with collagenase. By day 14, the wounds with GV/MB dressing alone and GV/MB dressing with collagenase had eschar covering less than 25% of the wound bed area compared with collagenase alone, medical grade honey, or moist gauze control, which showed eschar still covering over 75% of the wound bed area. Autolytic debridement activity of GV/MB foam dressings was evident in the porcine eschar study, as well as in the cases described.