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.

Implantation of cryopreserved umbilical cord allograft in hard-to-heal foot wounds: a retrospective study.

OBJECTIVE: The objective of this study was to assess the clinical effectiveness of surgically implanted cryopreserved human umbilical cord allograft in treating hard-to-heal wounds with and without osteomyelitis. METHOD: In this single-centre, retrospective investigation, wounds (average size 6.9±10.1cm2) were included for analysis that had failed prior standard wound care for an average of 14.4±8.0 weeks. RESULTS: After surgical implantation of cryopreserved umbilical cord between the deep tissue planes, 20 (95%) of the 21 wounds included in the study achieved complete closure in a median time of 7.8 weeks (range: 1-68) despite presence of residual osteomyelitis in 15 cases. A total of 12 wounds (57.1%) healed by 12 weeks, and 16 (76.2%) wounds healed by 24 weeks. A patient who presented with a limb-threatening calcaneal ulcer that was complicated by osteomyelitis at the time of treatment required subsequent amputation. No adverse events or complications related to cryopreserved umbilical cord were observed. CONCLUSION: The results suggest that surgical implantation of cryopreserved umbilical cord allograft may be a safe and effective treatment in improving healing of hard-to-heal wounds. Further prospective, randomised controlled trials are warranted.