Table 6.

Studies that used clinical indicators only to diagnose infection in chronic leg ulcers

Author(s), year	Study design	Sample size & Total leg ulcers	Clinical indicators used
Beele et al, 201080 Belgium and Netherlands	A randomised, prospective, open label, multi‐centre, multi‐national trial Compared antimicrobial effects of an ionic silver alginate/carboxymethylcellulose dressing with a non‐silver calcium alginate fibre dressing	36 clinically, critically colonised wounds: 24 CLUs	Continuous pain erythema, warmth, Moderate to serious exudates, >50% yellow/slough, discolouration of granulation tissue, friable granulation tissue that bleeds easily, pocketing at wound base, foul odour, and necrotic
Braumann et a., 201164 Germany	A cohort study	52 wounds: 2 CLUs 12 infected wounds	Pus, malodour, pain, erythema, oedema, and warmth
Bruce et al, 201265 United Kingdom and Ireland	A multi‐centre pre‐post evaluation study	14 chronic wounds: 10 CLUs	Erythema, heat, oedema, pain, and odour
Derbyshire, 201069	Case studies	3 cases: 2 CLUs	Delayed healing, heavy slough, extreme pain between dressing changes, heavy exudate; swelling
Dryden et al, 201688	Non‐comparative pre‐post evaluation study in a multi‐centre, international setting To explore the clinical effects of Surgihoney RO, a topical wound dressing in bacterial load, biofilm and healing	114 clinically infected wounds: 33 CLUs	Non‐healing, wound deterioration, green‐tinged or purulent/haemopurulent/seropurulent exudate, heavy or moderate level of exudate, slough or necrotic tissue.
Forlee et al, 201453 South Africa	A prospective, open, multi‐centre observational study To assess the clinical acceptability of the new gelling fibre dressing containing silver DURAFIBER Ag	14 VLUs: 12 clinically infected	Wound static or deteriorating, increased exudate/secretion levels, increased pain, increased temperature around the wound, discolouration of granulation tissue, friable granulation, tissue necrosis, local erythema, oedema, purulent drainage, and odour
Gago et al, 200854 Spain	A prospective, comparative, observational study To compare 3 types of silver dressing: Acticoat Comfeel Ag, hydrocolloid/Biatain Ag polyurethane foam; and Aquacel Ag	75 patients with infected chronic wounds: 50 leg ulcers	Pain, redness, heat, oedema, and/or purulent exudate
Harding et al, 201637 United Kingdom	A pre‐market non‐comparative controlled trial study To investigate the safety and performance of a next‐generation antimicrobial dressing AQUACEL Ag+	42 patients with clinically infected VLUs	Pain between two dressing changes, peri‐ulcer skin erythema/inflammation, oedema, malodour, and heavy exudate
Jørgensen et al, 200511 15 centres in 7 countries	A multi‐centre, open, block‐randomised and controlled trial study To compare the effect of a sustained silver‐release foam dressing Contreet Foam with a foam dressing Allevyn Hydrocellular without added silver in critically colonised VLUs with delayed healing	129 patients with CLUS, critically colonised	Wound healing stalled or delayed compared with the normal expectation for the patient; increased exudate levels within the past 4 weeks; increased pain in the study ulcer area within the past 4 weeks; discolouration of granulation tissue; and foul odour “clinical infection including erysipelas and cellulitis of periulcer skin”
Jorgensen et al, 200874 Denmark	An open non‐comparative observational study to investigate the effect and safety of Biatain‐Ibu combined with an ionised silver‐releasing wound contact layer‐ Physiotulle Ag	24 patients with locally infected VLUs	Painful; discolouration of the granulation tissue; exuding, Wound healing stalled or delayed compared with the normal expectation for the patient; and malodour
Lazareth et al, 201212 France	An open‐labelled, randomised, controlled trial for 4 weeks To assess the ability of a silver lipidocolloid contact layer in comparison with the same wound dressing not impregnated with silver salts to promote the healing process	102 patients with “heavy bacterial colonisation” VLUs	Pain between 2 dressing changes, peri‐wound erythema, oedema, foul odour, and heavy exudate. Patients presented with at least 3/5 local signs of heavy bacterial colonisation
Meaume et al, 200589	A randomised open‐label multi‐centre comparative two‐arm parallel‐group trial 13 centres recruited 99 patients with either VLUs or PUs to evaluate the clinical impact of using a silver‐releasing hydro‐alginate dressing	99 critically colonised chronic wounds: 71 VLUs	Continuous (spontaneous) pain, erythema, oedema, increase local warmth, moderate to high levels of exudate, at least 50% of the wound covered with yellow slough, discoloured or friable granulation tissue, pocketing or undermining at the base of the wound, or foul odour
Murphy, 201655 United Kingdom	4 case studies To describe the effect of Zorflex	4 VLUs	Case 1: painful 7/10, green slough; Case 2 yellow slough ~50%, heavy exudate, the wound failed to progress Case 3 painful non‐healing ulcer, the wound bed was red & inflamed, ~60% slough, wound was static, heavy exudate, excoriation to peri‐wound, failed to respond to treatment Case 4 the wound deteriorated, very painful 7/10, high volumes of exudate caused peri‐wound maceration
Trial et al, 201056 France	Prospective, open‐label, controlled, and randomised trial To compare the efficacy and tolerability of a new ionic silver alginate matrix Askina Calgitrol Ag with that of a standard silver‐free alginate dressing Algosteril	42 locally infected chronic wounds: 12 leg ulcers	Clinical infection score: (0–18): fever, local heat, peri‐lesional erythema; persistent pain between 2 dressing changes, oedema, malodour, pus, exudate production
Vanscheidt et al, 200373 Germany	A multi‐centre, non‐comparative, non‐randomised, pilot trial To evaluate primarily the safety and the initial performance of the ionic silver dressing Aquacel Ag	15 patients with CLUs: 11 clinically infected	Cellulitis, pain, slough, discharge, erythema, and friable granulation tissue
Vanscheidt et al, 201213 43 centres in the United Kingdom, Germany, France, Denmark and Poland	International, multi‐centre, double‐blind and randomised controlled clinical trial To evaluate the cytotoxic effect of octenidine dihydrochloride/phenoxyethanol in comparison with Ringer solution	126 patients with locally infected chronic VLU	Presence of at least 2/9: abscess, cellulites, discharge, discolouration, friable granulation tissue that bleeds easily, unexpected pain/tenderness or change in the nature of pain, pocketing at base of wound or wound breakdown, bridging of the epithelium or soft tissue and abnormal smell
Walker et al, 201557 Canada, United Kingdom, Germany, Denmark, Croatia, Spain, Lithuania, Italy, Czech, Rep Sweden, Bulgaria, Portugal, Slovakia, Netherlands	An international, multi‐centre, pragmatic, non‐randomised observational study To assess the effectiveness of AQUACEL Ag + dressing in facilitating healing in a variety of hard‐to‐heal wounds that may have been compromised by infection and/or biofilm	113 patients: 59 CLUs	Purulent exudate, erythema, oedema, malodour, friable granulation tissue, and discoloured granulation tissue
Woo et al, 201214 Canada	A prospective, open‐label, 4‐week randomised controlled trial To evaluate the effectiveness of a topical silver dressing that consists of silver alginate powder (Arglaes Powder) compared with moisture balance with foam alone‐ Optifoam	34 critically colonised chronic wounds: 13 CLUs	A standardised upper—critical colonisation: unhealthy tissue, pain, poor healing, exudate, and reek Lower—deep infection: larger in size, osseous tissue, warmth, oedema, and redness
Woo et al, 201258 Canada	Case series: 9 patients To evaluate the application of transdermal continuous topical oxygen therapy to promote healing in chronic wounds	9 patients with CLUs	Upper: unhealthy tissue, pain, poor healing, exudate, and reek for superficial wound infection Lower: larger size, osseous tissue, warmth, oedema, and redness for deep wound infection
Woo & Heil, 201741 Canada	Prospective, non‐randomised observational study To evaluate the performance of an antibacterial foam dressing containing methylene blue and gentian violet (Hydrofera Blue Classic dressing)	29 participants CLUs with localised infection	Upper: unhealthy tissue, pain, poor healing, exudate, and reek Lower: larger in size & new areas of breakdown, osseous tissue, warmth, oedema, and redness

CLUs, chronic leg ulcers; PUs, pressure ulcers; VLUs, venous leg ulcers.