A trial evaluating the efficacy of a unique keratin matrix graft to treat chronic diabetic foot ulcers found a “high rate of complete healing”.
The multicentre trial examined the outcomes of two application regimens of the graft in the treatment of Wagner grade one non-healing DFUs.
It involved 26 patients with chronic Wagner one DFUs who were treated with the graft, applied either weekly or bi-weekly, in addition to standard of care.
The hypothesis was that bi-weekly application would be similar to weekly application. The primary endpoint was complete wound closure by 12 weeks. Secondary endpoints included healing time, percent area reduction and weekly changes in peripheral neuropathy, pain and quality of life.
In the intent-to-treat population, 77% (10/13) of DFUs treated with bi-weekly application healed compared with 69% (9/13) treated with weekly application.
The mean time to heal within 12 weeks in the bi-weekly group was 61 days and in the weekly group was 54 days. The mean percent area reduction at 12 weeks was 94.7% in the bi-weekly group compared with 84.8% in the weekly group. The number of grafts used in the bi-weekly group was 3.9 compared with 6.2 in the weekly group.”
The authors concluded: “The results of this trial confirm our hypothesis that whether bi-weekly or weekly application of the unique keratin matrix graft is used to treat nonhealing indolent DFUs, there is a high rate of complete healing.
“Based on these results, future studies should be conducted that further investigate the use of this novel human keratin matrix graft for the treatment of chronic DFUs.”
