A prospective randomized controlled study with intermittent mechanical compression of the calf in patients with claudication

Objectives

The study tested the feasibility of using a new portable mechanical compression device for the treatment of claudication. The device applies intermittent non-pneumatic mechanical compression (IMC) to the calf. It was hypothesized that it can offer a low-cost convinient option for patients and achieve good compliance and improved clinical outcomes.

Methods

Thirty patients were enrolled in a randomized controlled single blind study. Fourteen patients were assigned to active IMC. Sixteen control patients continued with medical treatment alone. Outcomes were recorded at baseline, after one month, three months, and six months. The study examined changes in exercise tolerance using Initial Claudiacation Distance (ICD) and Absolute Claudiaction Distance (ACD) as well as ankle-brachial index at rest (ABI-r) and post-exercise (ABI-pe). All patients had stable claudication due to peripheral arterial disease (PAD) and were already under best medical treatment (BMT). To be eligible for inclusion, patients had to be between the ages of 50 and 75 years, had to have stable claudication with an absolute claudication distance >40 meters but <300 meters on a standardized treadmill stress test (3.8 km/h at a 10% grade), have a resting ABI in the affected limb <0.8 with a drop of at least 0.15 following exercise, in whom surgical intervention was not expected for at least three months. Fourteen patients were assigned to active IMC consisting of compressions 65 mm Hg in amplitude, applied for three 3-second compressions/minute, two hours/day for three months. Sixteen control patients continued with BMT alone.

Results

One month after treatment, ICD increased by 66% (P = .001), ACD increased by 51.75% (P = .005), and ABI-pe increased by 42% (P = .01). Treatment effects were maintained or further improved after three months. ABI-r did not increase at any time. Compliance exceeded 80%. Three months following cessation of therapy, claudication distances and ABI-pe did not decrease significantly.

Conclusions

We concluded that the use of IMC of the calf for three months increased claudication distances and led to objective improvements in ABI-pe. Intermittent mechanical compression may be a useful approach to patients with continued claudication despite standard medical treatment.