A recent collaborative international trial by medical institutions from Europe and the United States proved the major benefits of employing complete fish skin grafts to treat diabetic foot ulcers. The study, which involved 255 patients from various medical centres like the Diabetology Department, Centre Hopitalier Sud Francilien in France, and Mount Sinai Hospital in New York, USA, found that fish skin grafts resulted in faster and more complete healing than normal wound treatment methods.

Diabetic foot ulcers, especially those that penetrate deeply into bone, joint, or tendon, are notoriously difficult to treat. They pose a significant danger of infection, amputation, and even death. Traditional treatment procedures have shown mediocre outcomes, prompting the search for novel treatments, such as the use of biologically active materials like fish skin grafts.

Professor Jean-Pierre Dufresne of the Université d'Evry, one of the lead researchers, emphasised the trial's significance: "Diabetic foot ulcers are chronic and can become life-threatening when they penetrate deeper tissues." Our trial focused on these complex, high-risk wounds, to determine if intact fish skin grafts could speed up healing in these severe cases.

The trial, which ran from July 2020 to November 2022, was an open-label randomised controlled trial. The trial randomly assigned patients in a 1:1 ratio to either the intact fish skin graft or normal wound care for a period of 14 weeks. Investigators assessed healing at 16, 20, and 24 weeks, and a blinded adjudication committee confirmed the findings at each stage.

The researchers established the primary endpoint as the proportion of ulcers that healed within 16 weeks. The researchers defined healing as the complete reepithelization of the wound, which they confirmed 14 days later. The data clearly demonstrated the efficiency of fish skin grafts.

The investigation's findings were alarming. At 16 weeks, 44% of patients treated with fish skin grafts had complete healing, while only 26% had received standard therapy. By 20 weeks, the percentage of patients with healed ulcers had increased to 46% in the fish skin graft group against 32% in the control group. At 24 weeks, the difference widened further, with 55% of the fish skin graft group achieving full healing compared to 38% of the usual care group.

"Time to healing was also significantly faster for the fish skin graft group," said Dr. Maria Fiorenza of the University Hospital Pisa in Italy. "The average time to complete recovery was 17.3 weeks, against 19.4 weeks for normal care. This difference may appear insignificant, but it has important clinical implications for both patient recovery and healthcare costs."

The researchers also stated that the study results supported prior findings, which showed that fish skin grafts were beneficial in treating less severe (grade 1) ulcers. This research focused on complex wounds like UT grade 2 and 3 ulcers and ischaemic or infected ones. The faster healing period we saw confirms the ability of fish skin transplants to treat difficult patients," the research team said.

While overall healing rates were higher with fish skin grafts, the study found a slight increase in the prevalence of wound infections in this population. Primary wound infections occurred in approximately 30.2% of patients receiving fish skin grafts, compared to 24.6% in the standard care group. However, the researchers hypothesized that this might be due to the more intricate lesions in the fish skin graft group.

"The treatment's safety profile is something we are carefully monitoring," said Dr. Niels Pedersen of Frameshift in Denmark. "While infection rates are higher, we believe that the overall healing benefits outweigh the risks. Further research will assist in developing therapy regimens and resolving these problems.

The researchers found that fish skin grafts are a viable treatment for severe diabetic foot ulcers. "Our trial demonstrated that treatment with intact fish skin grafts not only increased the proportion of healed ulcers but also reduced the time to healing in a population of patients with deep, complex diabetic foot ulcers," the paper's authors stated.

Millions of patients suffering from this terrible ailment could find hope in this invention, which has the potential to transform the treatment of diabetic foot ulcers in clinical practice. With more investigation, fish skin grafts may become a common choice in wound treatment, particularly for non-superficial ulcers.