(CS-090) Clinical Experience with Human Keratin Matrix* in the Treatment of Venous Ulcers

Venous Leg Ulcers (VLUs) are the most common type of ulcer in the lower extremities and account for 70–80% of ulcers presenting for evaluation and treatment. VLUs are the long-term effect of untreated ambulatory venous hypertension, inflammation and decreased skin integrity. There are approximately 6 million patients with VLU in the US, with VLU prevalence up to 2% of the population that increases up to 5% over the age of 65. VLU healing times are usually between 16-20 weeks, but increase to more than a year, in larger ( >75cm2) VLUs, with a 50-70% recurrence rate.

Methods:

This retrospective study investigates the efficacy of a human keratin matrix* in promoting the healing of VLUs. The study included seven patients with VLUs ranging in size from 113 to 365 square centimeters and nine patients with VLUs ranging from 2.8 to 21.5 centimeters square who received the human keratin matrix* product, in addition to detailed noninvasive venous insufficiency identification, endovenous interventions, and compression.

Results:

Our findings revealed a 49% average reduction in surface area Venous size in the larger VLU group and a 69% reduction in the small to medium VLU group after just three applications of the human keratin matrix*. In the larger VLUs, the average reduction in ulcer area at the conclusion of the application regimen was 62%. These participants received 6 applications of the product on average. In the small to medium VLU group, 8 out of 9 (88%) VLUs healed completely during the study period. These participants averaged 4.5 applications of the human examined keratin matrix*.

Discussion:

There have been significant advances to our understanding of this type of Ulcer, and the development of endovenous interventions the last decade has been associated with improvements in healing times and reduction of recurrence rates. Simultaneously, several advances have been observed in the local management of VLUs. Despite the many options available for small VLUs, there is paucity of local products aiming to treat large VLUs. These outcomes indicate the significant potential of the human keratin matrix* as a promising intervention for the treatment of VLUs of all sizes.