Sucrose Octasulfate-Impregnated Dressings for Adults With Difficult-to-Heal Noninfected Diabetic Foot Ulcers and Difficult-to-Heal Noninfected Venous Leg Ulcers: A Health Technology Assessment.

Background: Diabetic foot ulcers and venous leg ulcers may not always heal in a timely manner despite proper wound care. Treatments that improve the healing rate of these ulcers would improve clinical outcomes for patients and may result in downstream cost savings for the health care system. We conducted a health technology assessment of sucrose octasulfate-impregnated dressings for adults with difficult-to-heal noninfected diabetic foot ulcers and difficult-to-heal noninfected venous leg ulcers, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding sucrose octasulfate-impregnated dressings, and patient preferences and values.

Methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Cochrane risk-of-bias tool for randomized trials (RoB 2) and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and analyzed the budget impact of publicly funding sucrose octasulfate-impregnated dressings for adults with difficult-to-heal noninfected diabetic foot ulcers and difficult-to-heal noninfected venous leg ulcers in Ontario. We did not conduct a primary economic evaluation because there is existing evidence to approximate the cost-effectiveness of sucrose octasulfate-impregnated dressings in Ontario. We leveraged 4 previous health technology assessments to explore the perspectives and experiences of patients with diabetic foot ulcers and venous leg ulcers, as well as the perspectives and experiences of their care partners.

Results: We included 3 randomized controlled trials and 2 subsequent publications of these randomized controlled trials in the clinical evidence review. Compared with dressings that do not contain sucrose octasulfate, sucrose octasulfate-impregnated dressings result in faster wound closure in patients with difficult-to-heal noninfected neuroischemic diabetic foot ulcers (GRADE: Moderate) and reduce ulcer size and improve health-related quality of life in the domains of pain/discomfort and anxiety/depression for patients with difficult-to-heal noninfected venous leg ulcers (GRADE: Moderate). The use of sucrose octasulfate-impregnated dressings with noninfected wounds is considered safe (GRADE: Moderate).The economic evidence showed that, compared with dressings that do not contain sucrose octasulfate, sucrose octasulfate-impregnated dressings are highly likely to be cost-effective for both difficult-to-heal noninfected diabetic foot ulcers and difficult-to-heal noninfected venous leg ulcers and would lead to cost savings due to faster and increased complete wound healing. The annual budget impact of publicly funding sucrose octasulfate-impregnated dressings in Ontario over the next 5 years would range from cost savings of $0.93 million in year 1 to $0.62 million in year 5 for adults with difficult-to-heal noninfected diabetic foot ulcers, and cost savings of $0.8 million in year 1 to $0.53 million in year 5 for adults with difficult-to-heal noninfected venous leg ulcers. Overall, we estimate that publicly funding sucrose octasulfate-impregnated dressings in Ontario for adults with difficult-to-heal noninfected diabetic foot ulcers and difficult-to-heal noninfected venous leg ulcers would lead to total cost savings of $3.91 million and $3.38 million, respectively, over the next 5 years.Patients with diabetic foot ulcers and venous leg ulcers discussed the effects of living with these wounds, as well as their treatment journey. They spoke about the burden of their condition and its negative impact on their daily lives, including mobility, employment, social activities, and mental health. Patients also spoke about the variety of treatment options available and the financial barriers to accessing these treatments.

Conclusions: Sucrose octasulfate-impregnated dressings are safe and improve the healing of difficult-to-heal noninfected neuroischemic diabetic foot ulcers and difficult-to-heal noninfected venous leg ulcers compared with dressings that do not contain sucrose octasulfate. We estimate that publicly funding sucrose octasulfate-impregnated dressings in Ontario would result in cost savings for both difficult-to-heal noninfected diabetic foot ulcers and difficult-to-heal noninfected venous leg ulcers. Evidence from patient engagement suggests that people with diabetic foot ulcers or venous leg ulcers face negative impacts on their quality of life, especially related to mobility. Patients spoke about their challenges, including long and difficult care journeys, as well as trying different treatment options to heal their ulcers and avoid amputation. It is not clear if the participants had direct experience with sucrose octasulfate-impregnated dressings, so we could not draw specific conclusions about these dressings from the preferences and values evidence.