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

E. B. Jude, J. Apelqvist, M. Spraul, J. Martini, G. Jones, K. Harding, S. Benbow, M. Young, Rayaz Malik, I. O'Brien, G. Charpentier, N. Vigier-Simorre, C. Le Devehat, L. Richard, W. Vanscheidt, C. Muenter, M. Baer

Research output: Contribution to journalArticle

95 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)280-288
Number of pages9
JournalDiabetic Medicine
Volume24
Issue number3
DOIs
Publication statusPublished - Mar 2007
Externally publishedYes

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Diabetic Foot
Bandages
Silver
Ulcer
Anti-Bacterial Agents
Safety
alginic acid
Debridement
Type 1 Diabetes Mellitus
Amputation
Type 2 Diabetes Mellitus
Multicenter Studies
Lower Extremity
Outpatients
Prospective Studies
Wounds and Injuries
Infection

Keywords

  • Alginate
  • Antibiotic
  • Diabetes
  • Foot ulcer
  • Hydrofiber® dressing
  • Silver
  • Synergy

ASJC Scopus subject areas

  • Endocrinology
  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

Prospective randomized controlled study of Hydrofiber® dressing containing ionic silver or calcium alginate dressings in non-ischaemic diabetic foot ulcers. / Jude, E. B.; Apelqvist, J.; Spraul, M.; Martini, J.; Jones, G.; Harding, K.; Benbow, S.; Young, M.; Malik, Rayaz; O'Brien, I.; Charpentier, G.; Vigier-Simorre, N.; Le Devehat, C.; Richard, L.; Vanscheidt, W.; Muenter, C.; Baer, M.

In: Diabetic Medicine, Vol. 24, No. 3, 03.2007, p. 280-288.

Research output: Contribution to journalArticle

Jude, EB, Apelqvist, J, Spraul, M, Martini, J, Jones, G, Harding, K, Benbow, S, Young, M, Malik, R, O'Brien, I, Charpentier, G, Vigier-Simorre, N, Le Devehat, C, Richard, L, Vanscheidt, W, Muenter, C & Baer, M 2007, 'Prospective randomized controlled study of Hydrofiber® dressing containing ionic silver or calcium alginate dressings in non-ischaemic diabetic foot ulcers', Diabetic Medicine, vol. 24, no. 3, pp. 280-288. https://doi.org/10.1111/j.1464-5491.2007.02079.x
Jude, E. B. ; Apelqvist, J. ; Spraul, M. ; Martini, J. ; Jones, G. ; Harding, K. ; Benbow, S. ; Young, M. ; Malik, Rayaz ; O'Brien, I. ; Charpentier, G. ; Vigier-Simorre, N. ; Le Devehat, C. ; Richard, L. ; Vanscheidt, W. ; Muenter, C. ; Baer, M. / Prospective randomized controlled study of Hydrofiber® dressing containing ionic silver or calcium alginate dressings in non-ischaemic diabetic foot ulcers. In: Diabetic Medicine. 2007 ; Vol. 24, No. 3. pp. 280-288.
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AU - Spraul, M.

AU - Martini, J.

AU - Jones, G.

AU - Harding, K.

AU - Benbow, S.

AU - Young, M.

AU - Malik, Rayaz

AU - O'Brien, I.

AU - Charpentier, G.

AU - Vigier-Simorre, N.

AU - Le Devehat, C.

AU - Richard, L.

AU - Vanscheidt, W.

AU - Muenter, C.

AU - Baer, M.

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N2 - 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.

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