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Prospective randomized controlled study of Hydrofiber® dressing containing ionic silver or calcium alginate dressings in non‐ischaemic diabetic foot ulcers
Author(s) -
Jude E. B.,
Apelqvist J.,
Spraul M.,
Martini J.
Publication year - 2007
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/j.1464-5491.2007.02079.x
Subject(s) - medicine , diabetic foot , diabetic foot ulcer , diabetes mellitus , adverse effect , diabetic ulcers , surgery , prospective cohort study , debridement (dental) , amputation , randomized controlled trial , endocrinology
Aims Diabetic foot ulcers (DFUs) are at risk of infection and impaired healing, placing patients at risk of lower extremity amputation. DFU care requires debridement and dressings. A prospective, multicentre study compared clinical efficacy and safety of AQUACEL® Hydrofiber® dressings containing ionic silver (AQAg) with those of Algosteril® calcium alginate (CA) dressings in managing out‐patients with Type 1 or 2 diabetes mellitus and non‐ischaemic Wagner Grade 1 or 2 DFUs. Methods Patients stratified by antibiotic use on enrolment were randomly assigned to similar protocols including off‐loading, AQAg ( n = 67) or CA ( n = 67) primary dressings and secondary foam dressings for 8 weeks or until healing. Clinical efficacy measures were healing outcomes and primarily healing speed. Adverse events were recorded. Results AQAg and CA groups were comparable at baseline. All ulcer healing outcomes improved in both groups. The mean time to healing was 53 days for AQAg ulcers and 58 days for CA ulcers ( P = 0.34). AQAg‐treated ulcers reduced in depth nearly twice as much as CA‐treated ulcers (0.25 cm vs. 0.13 cm; P = 0.04). There was more overall ulcer improvement and less deterioration in AQAg subjects ( P = 0.058), particularly in the subset initially using antibiotics ( P = 0.02). Safety profiles of both groups were similar. Conclusion When added to standard care with appropriate off‐loading, AQAg silver dressings were associated with favourable clinical outcomes compared with CA dressings, specifically in ulcer depth reduction and in infected ulcers requiring antibiotic treatment. This study reports the first significant clinical effects of a primary wound dressing containing silver on DFU healing.