1.
Treprostinil sodium (Remodulin), a prostacyclin analog, in the treatment of critical limb ischemia: open-label study.
Berman, S, Quick, R, Yoder, P, Voigt, S, Strootman, D, Wade, M
Vascular. 2006;(3):142-8
Abstract
The purpose of this study was to assess the safety of continuous subcutaneous therapy with treprostinil sodium (Remodulin), a prostacyclin analog, and its effect on ischemic rest pain and ischemic wound healing in subjects with critical limb ischemia (CLI) and no planned revascularization procedure. This was a 12-week, open-label, single-center pilot study enrolling 10 subjects (mean age 82.4 years) with Fontaine stage III to IV (Rutherford class 4-6) peripheral arterial disease and ankle brachial indices less than 0.55. The primary end point was safety, and the secondary end points were the effects of treatment on ischemic rest pain, limb salvage, and wound healing. There was a 62% reduction in mean worst rest pain and a 57% reduction in mean average rest pain at week 12, with most subjects using less pain medication. Three subjects experienced complete healing of their wounds. No subject developed a new wound during the trial. Treprostinil was generally well tolerated. Subcutaneous infusion-site pain was the most frequently reported side effect, with one subject withdrawing from the study as a result. Jaw pain was reported by two subjects. One subject experienced two serious adverse events considered unrelated to treprostinil (cholecystitis and congestive heart failure). This study demonstrates that chronic, continuous subcutaneous treprostinil is safe and can be useful in the treatment of ischemic pain and wounds in subjects with CLI. Future controlled studies are needed to evaluate these effects and determine appropriate patient selection.
2.
Experimental evaluation of the effect of raised pressure in a single compartment in the lower leg on neighbouring compartments using fresh above knee amputated legs-a study of interstitial pressures with two case reports.
Seel, EH, Wijesinghe, LD, O'Connor, D
Injury. 2005;(9):1113-20
Abstract
STUDY DESIGN Experimental evaluation of intracompartmental pressures in a fresh above knee amputated human leg. OBJECTIVES To determine what effect raised pressure in one compartment of the lower leg had upon its neighbour. SUMMARY OF BACKGROUND DATA There has been no previous reports of isolated compartment pathology, following low velocity trauma, causing a compartment syndrome in all four compartments of the lower leg. METHODS Immediately after leg amputation, the intracompartmental pressure in the deep posterior compartment was artificially raised to 100 mmHg with infused 0.9% sodium chloride solution. The resultant pressure changes in remaining compartments were recorded over 30 min. RESULTS Five legs were evaluated. After 30 min, the mean maximum intracompartmental pressure increase found in the superficial posterior, anterior and peroneal compartments was 78.4 mmHg (range 65-94 mmHg), 25.2 mmHg (range 14-31 mmHg) and 24.8 mmHg (range 15-31 mmHg), respectively. CONCLUSIONS This experimental data and case reports show that a compartment in which there is raised pressure may exert external pressure on a neighbouring compartment that can result in physiological changes to induce a compartment syndrome within that neighbour. The importance of assessing all compartments within a limb segment, even when associated with low velocity trauma, remains paramount.