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. 2018 Sep 1;2018(9):CD012841. doi: 10.1002/14651858.CD012841.pub2

Gohel 2008.

Methods Prospective cohort study
Setting: nurse‐led specialist leg ulcer service
Country: UK
Duration of follow‐up: 5 weeks
Treatments: non‐adhesive dressings and compression bandaging
Participants 80 participants with VLUs (ABPI ≥ 0.85 open ulceration; chronic ulcers)
Median age (range): 75 (40‐93) years
Sex (M:F): 43:37
Stage of ulcer: CEAP grades (level II) C6sEp in 68 and C6sEs in 12
Ulcer duration: chronicity median (range) 3 (1‐180) months
Ulcer size at baseline: median (range) 4.7 (0.1‐142.4) cm²
Wound infection: 0 participants had signs of soft tissue infection
Number of wounds: 80 (for participants with bilateral areas, largest was studied)
Inclusion criteria: new and follow‐up participants with open ulceration between the ankle and knee and an ABPI ≥ 0.85. Duplex evidence of venous reflux
Exclusion criteria: not stated
Prognostic factors MMP‐2 and MMP‐9 (continuous data); pro‐MMP only. Measurement method gelatin zymography: MMP concentrations expressed as a percentage of an MMP‐2 standard sample used for all assays
Time of measurement: baseline and 5 weeks measured. No results given for correlations with baseline, but with change from baseline
Wound fluid sampling method: occlusive dressings. Only 34/74 people had wound fluid
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Selection bias High risk < 2 months' follow‐up (5 weeks). Otherwise representative (consecutive new and follow‐up patients with open ulceration between the ankle and knee and an ABPI ≥ 0.85 were targeted)
Attrition bias Unclear risk Moderate: assessments were attended by 74/80 (93%) participants; unclear whether this is likely to affect the results
Prognostic factor measurement High risk Inappropriate biomarker measure: all assays performed using a sandwich ELISA technique. Only pro‐MMP reported and not cleaved to give an active form. Wound fluid collection 52/80 (65%) at baseline
Outcome measurement Unclear risk Moderate: unclear if blinded. 'Complete ulcer healing' reported, but only useable results were change in ulcer size. No details on assessment
Adjustment factors Unclear risk Moderate: partial, at least half, but not all, key adjustment factors taken into account in design or analysis (no symptoms of infection in soft tissues)
Analysis and reporting High risk Analysis concerned correlations between changes in ulcer healing and changes in pro‐MMP levels. Baseline MMP levels not reported. Change in size not adjusted for baseline
Overall risk of bias High risk