BACKGROUND: Conventional compression therapy of venous leg ulcers consists of applying pressure bandages; this operation is not simple and requires training. A heelless open-toed elastic compression device knitted in tubular form (Tubulcus, Laboratoires Innothera, Arcueil, France) represents a valuable alternative. It provides graduated compression with a value of 30 to 40 mmHg at the ankle. Appropriate pressure is exerted regardless of the skill of the fitter (who may even be the patient), and fitting of the device is facilitated by the use of a specific positioner. The aim of this trial was to compare the efficacy and tolerability of the new compression device and a short-stretch compression bandage (Rosidal K, Lohmann and Rauscher International GmbH and Co KG, Rengsdorf, Germany) for 12 weeks in patients with venous leg ulcers. MATERIALS AND METHODS: This was an open, randomized, comparative, international multicenter trial in two parallel groups in France, Germany, Austria, and Switzerland. Study patients had venous ulcers for less than three months, and ulcers measured no more than 5 cm in diameter. Ulcer area was assessed by a physician by means of computerized planimetry each week or on premature discontinuation of treatment. The per-protocol (PP) population comprised 88 patients treated with the tubular device (50 in France/Switzerland, 38 in Germany/Austria) and 90 treated with bandages (52 in France/Switzerland, 38 in Germany/Austria). RESULTS: Complete healing was observed in 58 percent of patients in the tubular compression device group and in 56.7 percent in the bandage group. The difference between the two treatment groups was -1.3 percent, and the 90-percent confidence interval (-13.5% to 10.9%) was within the limits of noninferiority specified in the protocol, ie, change = 15%. These results show that the efficacy of the tubular device was not inferior to that of bandages and that neither treatment was superior in efficacy to the other. The surface area of ulcers not completely healed within 12 weeks was reduced in 67.6 percent of patients treated with the tubular device and in 59 percent of those treated with bandaging. The median healing time was 42 days (in patients with complete healing), with no difference between the two treatment groups (p = 0.80). CONCLUSION: The results of this trial demonstrate the noninferiority of efficacy of a new type of tubular compression device compared with short-stretch bandages. The good healing rates, particularly with bandages, was doubtless assisted by the very high rate of compliance and the fact that bandaging was performed only by experienced medical staff.

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