Final efficacy and cost analysis of a fish skin graft vs standard of care in the management of chronic diabetic foot ulcers: a prospective, multicenter, randomized controlled clinical trial.

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.

Evaluating the effect of omega-3-rich fish skin in the treatment of chronic, nonresponsive diabetic foot ulcers: penultimate analysis of a multicenter, prospective, randomized controlled trial.

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.

A Multicenter, Blinded, Randomized Controlled Clinical Trial Evaluating the Effect of Omega-3-Rich Fish Skin in the Treatment of Chronic, Nonresponsive Diabetic Foot Ulcers.

INTRODUCTION: Omega-3-rich fish skin grafts have been shown to accelerate wound healing in full-thickness wounds. OBJECTIVE: The goal of this study was to compare the fish skin graft with standard of care (SOC) using collagen alginate dressing in the management of treatment-resistant diabetic foot ulcers (DFUs), defined as superficial ulcers not involving tendon capsule or bone. MATERIALS AND METHODS: Patients with DFUs who were first treated with SOC (offloading, appropriate debridement, and moist wound care) for a 2-week screening period were then randomized to either receiving SOC alone or SOC plus fish skin graft applied weekly for up to 12 weeks. The primary endpoint was the percentage of wounds closed at 12 weeks. RESULTS: Forty-nine patients were included in the final analysis. At 12 weeks, 16 of 24 patients' DFUs (67%) in the fish skin arm were completely closed, compared with 8 of 25 patients' DFUs (32%) in the SOC arm (P value = .0152 [N = 49]; significant at P < .047). At 6 weeks, the percentage area reduction was 41.2% in the SOC arm and 72.8% in the fish skin arm. CONCLUSIONS: The application of fish skin graft to previously nonresponsive DFUs resulted in significantly more fully healed wounds at 12 weeks than SOC alone. The study findings support the use of fish skin graft for chronic DFUs that do not heal with comprehensive SOC treatment.

Use of Ovine-based Collagen Extracellular Matrix and Gentian Violet/Methylene Blue Antibacterial Foam Dressings to Help Improve Clinical Outcomes in Lower Extremity Wounds: A Retrospective Cohort Study.

Dressings that provide broad spectrum metalloprotease reduction along with inherent aspects of an extracellular matrix may contribute to improved wound healing outcomes and shorter treatment times. OBJECTIVE: The author performed a retrospective case series analysis to determine the clinical outcomes of regular debridement with the use of ovine-based collagen extracellular matrix dressings and gentian violet/methylene blue polyurethane antibacterial foam dressings in treating 53 patients with 53 chronic lower extremity wounds (diabetic foot ulcers [DFUs], venous leg ulcers, and heel pressure ulcers). MATERIALS AND METHODS: Patients were treated twice weekly in an outpatient clinic for the first 4 weeks and weekly thereafter until closure. RESULTS: Average body mass index (BMI) for the study population was 28.3, and the average patient age was 75.9 years. Mean percent wound surface area reduction at 4, 8, and 12 weeks was 38.5%, 73.3%, and 91.3%, respectively. Average time to closure for all wounds was 10.6 weeks (range, 5-24 weeks). All wounds were 100% reepithelialized by week 20 except 1 DFU that reepithelialized at week 24. The average cost of care for a single wound episode (from presentation to closure) was $2749.49. CONCLUSION: Results of this analysis showed that the healing of chronic wounds in this series could be achieved at a reasonable cost with regular debridement and a collagen matrix dressing regimen, even in patients of advanced age and above average BMI as well as in wounds that did not achieve > 40% wound surface area reduction at 4 weeks.

Use of a Dehydrated Amniotic Membrane Allograft in the Treatment of Lower Extremity Wounds: A Retrospective Cohort Study.

Injuries to the skin are extensively costly to the health care system. When caused by metabolic and vascular compromise, these injuries are even more foreboding for patients. They can result in chronic inflammation, reduced mobility, and chronic pain. MATERIALS AND METHODS: Twenty patients were selected from the author's patient population at the West Boca Center for Wound Healing for a retrospective cohort study. Patients underwent a run-in period of 2 weeks, where standard of care was used to clear the wound of bioburden. A dehydrated, human amniotic membrane (dHAM; WoundEx Membrane, Skye Biologics, Inc, El Segundo, CA) was applied at weeks 1 (2 weeks post run-in), 3, and 5, if necessary. Wound measurements and photographs were performed weekly. Data were collected through a standard form in each patient's medical record to improve reliability and reproducibility. The data extraction was performed by the author and to reduce bias. Reduction of bias was performed by selecting patients whose wounds already were established and in temporal sequence. RESULTS: In this review of 20 patients treated with the dHAM, the author was able to effectively close all wounds in approximately 9.9 weeks (69.3 days). A linear relationship was discovered between wound size in cm2 and days to closure. Diabetic foot ulcers closed on average in 11.8 weeks (82.6 days) and venous leg ulcers in 9.2 weeks (64.4 days). No adverse events were noted secondary to the dHAM application, which shows this is a safe and effective treatment option. As of the date of this publication, there is no recurrence of the ulcerations noted. CONCLUSION: The use of this particular dHAM allograft effectively closed diabetic foot ulcerations in 82.6 days and median wound closure in 69.3 days. This poses as an advantageous clinical benefit in the scope of treatment of lower extremity wounds.

Proactive and Early Aggressive Wound Management: A Shift in Strategy Developed by a Consensus Panel Examining the Current Science, Prevention, and Management of Acute and Chronic Wounds.

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.

Use of a Novel Two-layer Bandage in the Treatment of Chronic Venous Hypertension.

Since the development of Unna boot therapies, there has been development in newer technologies for venous compression syndromes and chronic venous hypertension. Chronic lower extremity venous insufficiency results in venous stasis, edema and hypercongestion of the lower extremities. Given the breadth of potential uses, the goal of this study was to retrospectively compile and analyze the clinical application and effectiveness of a 2-layer zinc-impregnated foam Unna boot bandage (Andover Healthcare, Salisbury, MA) in patients with lower extremity swelling with or without wounds treated by a single physician and monitored for 12 weeks post-application in the outpatient setting. In patients with complex comorbidities, the use of this new foam-impregnated multi-layer compression Unna boot shows efficacy in reduction of edema and wound size within 12 weeks. This newer therapy shows extensive promise in the ability to keep patients adherent to treatment regimens with higher rates of success.