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 |
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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 |
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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 |
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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 |