A factorial, randomized trial of pentoxifylline or placebo, four-layer or single-layer compression, and knitted viscose or hydrocolloid dressings for venous ulcers.

OBJECTIVES: We evaluated the effectiveness of pentoxifylline, knitted viscose or hydrocolloid dressings, and single-layer or four-layer bandaging for venous ulceration. METHOD: A factorial randomized controlled trial with 24-week follow-up was conducted in leg ulcer clinics in Scotland with blinded allocation to pentoxifylline (1200 mg) or placebo, knitted viscose or hydrocolloid dressings, and single-layer or four-layer bandages. The study enrolled 245 adults with venous ulcers. The main outcome measure was time to complete healing. Secondary outcomes included proportions healed, withdrawals, and adverse events. Analysis was by intention to treat. RESULTS: There was no evidence of interaction between the drug, bandages, and dressings. Pentoxifylline was associated with nonsignificant increased ulcer healing (62% vs 53%; P = .21). Four-layer bandages were associated with significantly higher healing rates (67% vs 49%; P = .009). There was no difference in healing between knitted viscose and hydrocolloid dressings (58% and 57%; P = .88). Cox regression models increased the significance of the pentoxifylline effect (relative risk of healing, 1.4; 95% confidence interval, 1.0 to 2.0). CONCLUSIONS: Pentoxifylline increased the proportion healing compared with placebo to the same extent as shown in recent systematic reviews, although this finding was only statistically significant when a secondary adjusted analysis was conducted. Four-layer bandaging produced higher healing rates than single-layer bandaging. There was no difference in time to healing between knitted viscose and hydrocolloid dressings.

Prevention of recurrence of venous ulceration: randomized controlled trial of class 2 and class 3 elastic compression.

OBJECTIVE: To compare venous ulcer recurrence and compliance with two strengths of compression hosiery. METHODS: This study was a randomized controlled trial with a 5-year follow-up. The setting was the leg ulcer clinics of a teaching and a district general hospital in Scotland, United Kingdom. Patients were 300 outpatients with recently healed venous ulcers, with no significant arterial disease, rheumatoid disease, or diabetes mellitus. Interventions were fitting and supply of class 2 or class 3 compression hosiery. Four-monthly refitting by trained orthotists and surveillance by specialist nurses were performed. The main outcome measures were recurrence of leg ulceration and compliance with treatment. RESULTS: Thirty-six percent (107/300) of patients had recurrent leg ulceration by 5 years. Recurrence occurred in 59 (39%) of 151 class 2 elastic compression cases and in 48 (32%) of class 3 compression cases. One hundred six patients did not comply with their randomized compression class, 63 (42%) in class 3 and 43 (28%) in class 2. The difference in recurrence is not statistically significant, but our estimate of the effectiveness of class 3 hosiery is diluted by the lower compliance rate in this group. Restricted ankle movement and four or more previous ulcers were associated with a higher risk of recurrence. CONCLUSIONS: There was no evidence of a difference in recurrence rates at the classic level of significance (5%), but the lowest recurrence rates were seen in people who wore the highest degree of compression. Therefore, patients should wear the highest level of compression that is comfortable.