The objective of this study was to compare healing rates and costs of treat
ing venous ulcers with traditional Unna boots (UB) or a CircAid Thera-Boot
(TB). A multicenter, prospective, randomized parallel-group study was perfo
rmed in three university medical center vascular surgery clinics and three
private medical offices. Patients presented with unilateral venous leg ulce
rs 5 cm or less in diameter. Patients with severe arterial, metabolic, or n
europathic diseases, and those who would not be expected to heal with conse
rvative treatment, were excluded. Conservative treatment of the leg ulcer c
onsisted of a nonadherent topical dressing and compression with either a tr
aditional Unna's boot or a Thera-Boot. The main outcome measures were the f
ollowing: time to healing, rate of area decrease, rate of percent area decr
ease, linear healing rate, costs of labor, materials, and overhead. Of 38 e
nrolled patients seven were withdrawn (five UB, two TB), Three patients wer
e still in treatment when the study was stopped. Eleven UB patients and 17
TB patients completed the study. Healing rates were for UB and TB patients
(mean +/- sd) were, respectively: time to healing (weeks) 9.69 +/- 3.28, 7.
98 +/- 4.41 (p = 0.41), area healing rate (cm(2)/day) 0.0239 +/- 0.0534, 0.
0433 +/- 0.0910 (p = 0.27), % area healing rate (%/day) 1.0493 +/- 1.5583,
2.0357 +/- 1.9520 (p = 0.56), and linear healing rate (cm/day), 0.0060 +/-
0.0092, 0.0109 +/- 0.0125 (p = 0.27). Costs for UB and TB (dollars to compl
etion) were, respectively: clinician labor 331.37 +/- 255.75, 201.91 +/- 13
1.17 (p = 0.09), materials 160.86 +/- 96.86, 122.79 +/- 27.59 (p = 0.14), o
verhead (number of visits) 11.70 +/- 6.40, 6.71 +/- 3.77 (p = 0.02), and to
tal costs 901.73 +/- 576.45, 559.41 +/- 290.75 (p = 0.05).
Treatment of venous ulcers with CircAid Thera-Boots is significantly less c
ostly than treatment with traditional Unna's boots. Trends toward faster he
aling were noted.