Prospective randomized controlled study of Hydrofiber dressing containing ionic silver or calcium alginate dressings in non-ischaemic diabetic foot ulcers.
OBJECTIVE
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.


CONCLUSIONS
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.
Jude
E B
EB
Department of Diabetic Medicine, Tameside General Hospital, Ashton-Under-Lyne, UK. edward.jude@tgh.nhs.uk
Apelqvist
J
J
Spraul
M
M
Martini
J
J
D000368:Aged; D000464:Alginates / Q000592:standards / Q000627:therapeutic use*; D001458:Bandages; D017719:Diabetic Foot / Q000628:therapy*; D005260:Female; D020723:Glucuronic Acid / Q000592:standards / Q000627:therapeutic use; D006603:Hexuronic Acids / Q000592:standards / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018030:Silver Compounds / Q000592:standards / Q000627:therapeutic use*; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects*
D000464:Alginates; D006603:Hexuronic Acids; D018030:Silver Compounds; D020723:Glucuronic Acid