January 04, 2018
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Sucrose octasulfate wound dressing may speed healing in diabetic foot ulcers

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Patients with a noninfected neuroischemic diabetic foot ulcer were more likely to achieve wound closure within 20 weeks when randomly assigned a sucrose octasulfate dressing vs. those assigned a standard wound dressing, according to findings published in The Lancet Diabetes & Endocrinology.

“Delayed wound healing in neuroischemic diabetic foot ulcers has been related to excess matrix metalloprotease concentrations; these proteins destroy components of the extracellular matrix and damage growth factors and their receptors that are essential for healing,” Michael Edmonds, MD, of the Diabetic Foot Clinic at King’s College Hospital in London, and colleagues wrote. “Sulfated oligosaccharides are known to have many biological activities; in particular, the potassium salt of sucrose octasulfate has been shown to inhibit matrix metalloproteases and to interact with growth factors and restore their biological functions because it has high charge density.”

Edmonds and colleagues analyzed data from 240 patients with diabetes and a noninfected neuroischemic diabetic foot ulcer of grade IC or IIC, with a wound area greater than 1 cm, enrolled between March 2013 and March 2016. After a 2-week screening period, researchers randomly assigned patients to a sucrose octasulfate dressing (UrgoStart Contact, Urgo Medical Laboratories; n = 126; 82% men; mean age, 65 years; mean BMI, 29.8 kg/m²) or a control dressing (n = 114; 86% men; mean age, 64 years; mean BMI, 30.4 kg/m²) for 20 weeks. The octasulfate dressing was a nonadherent, nonocclusive wound dressing with a flexible contact layer composed of a polyester mesh, impregnated with a lipidocolloid matrix containing sucrose octasulfate potassium salt, according to researchers. The control dressing (UrgoTul, Urgo Medical Laboratories) had the same composition as the treatment dressing without the sucrose octasulfate potassium salt. Primary outcomes were the proportion of patients with wound closure at 20 weeks; secondary outcomes included estimated time to reach wound closure and absolute and relative wound surface area regression.

At 20 weeks, 60 patients in the octasulfate dressing group (48%) and 34 patients in the control group (30%) achieved wound closure; adjusted OR was 2.6 (95% CI, 1.43-4.73) for wound closure with the octasulfate dressing vs. control. Additionally, patients assigned to the octasulfate wound dressing experienced a shorter wound duration; OR was 0.27 (95% CI, 0.15-0.51) for closure of wounds in at least 6 months vs. closure of wounds in 6 months or less. The estimated mean time to wound closure was 60 days longer in the control dressing group vs. the octasulfate dressing group.

“Furthermore, a greater reduction in absolute wound surface area and in relative wound surface area, and a faster wound re-epithelialization wave were recorded in the sucrose octasulfate dressing group than in the control group by week 20,” the researchers wrote.

Patient-reported quality of life was similar between groups at the end of the study and remained poor overall, according to researchers, likely driven by restrictions of mobility and activity. The most frequent adverse event in both groups was infection of the target wound.

The trial steering committee enrolled only patients with noninfected neuroischemic diabetic foot ulcers greater than 1 cm to ensure a homogeneous cohort, the researchers noted, adding that the study outcomes may not apply to patients with similar wounds that are less than 1 cm in size.

“A sucrose octasulfate dressing is effective and safe, and its use is easy to implement by all health care professionals,” the researchers wrote. “This dressing could form an important part of modern, multidisciplinary management of neuroischemic diabetic foot ulcers.” – by Regina Schaffer

Disclosures: Urgo Medical Laboratories funded this study. Edmonds and eight other study authors report they received nonfinancial support from Urgo Medical Laboratories. Please see the study for the other authors’ relevant financial disclosures.