Comparison of elastic versus nonelastic compression in bilateral venous ulcers: a randomized trial.

BACKGROUND: There is controversy regarding the effectiveness of elastic vs nonelastic compression in the healing of venous leg ulcers. To gain insight into this controversy, we randomly compared a four-layer elastic bandage with a nonelastic garment (CircAid) in patients with venous leg ulcers.
METHODS: Twenty-four extremities of 12 patients with bilateral leg ulcers were randomized to have a four-layer elastic bandage in 1 extremity and a nonelastic compression garment CircAid in the contralateral limb. The CEAP classification in 22 extremities was C(6 S); ES; A(D6,14,15,P18); PR; 1 extremity in 2 patients was C(6 S); E(S); A(D 6,14,15,P18); PRO. There were seven men and five women. Age ranged from 45 to 82 years, with a mean of 61 years. All patients had postthrombotic leg ulcers diagnosed clinically by duplex ultrasonography (n = 8) or by phlebography (n = 4). Every 4 weeks, patients had the ulcer area measured in square centimeters by a computerized scanning method and had the limb girth measured in centimeters at the foot, ankle, and calf. The ankle-brachial index was determined in all cases. Color photographs of the ulcer areas were taken monthly to assess healing progress. All patients were compliant. Results were assessed at 12 weeks. A patient satisfaction sheet was filled out by the patient, who circled one of the following scores: 3, very satisfied; 2, moderately satisfied; and 1, not satisfied. Cox proportional hazards models or paired t tests were used for comparison.
RESULTS: The 24 limbs were randomized and divided into 2 groups of 12 each. Group A received CircAid, and group B, a four-layer elastic bandage. Duplex scanning showed a pattern of reflux in 11 limbs of each group. One limb in each group had a pattern of obstruction documented by air plethysmography (n = 2). Phlebography demonstrated the anatomic site in both limbs. The initial ulcer area in group A was 48.98 +/- 14.13 cm2 and was 50.08 +/- 18.30 cm2 in group B (P = .9285). The ulcer healing rate was significantly faster in group A compared with group B (hazard ratio, 0.56; 95% confidence interval, 0.33-0.96; P = .0173). Ulcers with hemodynamic obstruction had a protracted course when compared with the contralateral limbs with reflux. There was no significant difference in girth reduction between groups A and B (hazard ratio, 2.36; 95% confidence interval, 0.30-18.52; P = .3580). The ankle-brachial index was normal (> or = 1.0) in all patients.
CONCLUSIONS: In compliant patients, venous leg ulcers randomized to nonelastic compression had a significantly faster healing rate per week than ulcers treated by the conventional four-layer compression system.

RCT Entities:   Population Interventions Outcomes