PURPOSE

Critical limb ischemia (CLI) is equated with a need for limb salvage. Arterial reconstruction and major amputation are the therapies ultimately available to such patients. We studied whether measurements of skin perfusion pressure (SPP) can be used to accurately identify those patients with CLI who require vascular reconstruction or major amputation and distinguish them from patients whose foot ulcer would heal with local wound care or minor amputation.

METHODS

Fifty-three patients with a total of 61 limbs with a nonhealing foot ulcer (age range, 47 to 88 years; mean, 70.8 +/- 9.8 years; 33 men, 20 women) who were referred to the Vascular Laboratory at Morristown Memorial Hospital for evaluation of arterial insufficiency were studied in a prospective, double-blinded fashion. Patients were included in the study if informed consent was obtained, and patients were excluded if there was uncontrolled sepsis or if they required guillotine amputation. The size and site of the foot ulcer was recorded. If gangrene was present, the location and extent was also noted. The pulses were examined and recorded, and the ankle-brachial index was determined for each limb. Measurements of SPP were made at the proximal margin of the ulcer in viable tissue (not in the bed of the ulcer). SPP measurements were made independent of the vascular surgeon's evaluation of the limb and were not part of his clinical decision regarding management of the foot ulcer. The SPP measurements were compared (Fischer's exact test) with the clinical decision for therapy (group I, arterial reconstruction or major amputation; or group II, wound debridement, minor amputation, or both). SPP was also compared with the outcome (ulcer healed or failed to heal) of therapy in group II. From contingency tables we calculated the sensitivity, specificity, positive and negative predictive values (PPV, NPV), and the overall accuracy of SPP measurement as a diagnostic test for critical limb ischemia.

RESULTS

There was no difference in the size or location of foot ulcers between groups I and II, nor was there a difference in ulcer size or location between limbs that healed and did not heal in group II. The prevalence of diabetes was similar in all groups and subgroups. The ABI was not predictive of the need for reconstruction or major amputation nor the outcome of local therapy. SPP measurements identified 31 of 32 limbs diagnosed as having CLI by clinical evaluation (i.e., group I, those limbs that required vascular reconstruction or major amputation). Of those patients who were clinically assessed as not having CLI (group II), SPP measurements diagnosed 12 of the 14 limbs that did not heal as having CLI (PPV, 75%) and 11 of 15 limbs that did heal as not having CLI (NPV, 85%). The sensitivity of SPP less than 30 mm Hg as a diagnostic test of CLI was 85%, and the specificity was 73%. The overall diagnostic accuracy of SPP less than 30 mm Hg as a diagnostic test of critical limb ischemia was 79.3% (p < 0.002, Fischer's exact test).

CONCLUSIONS

We conclude that SPP measurement is an objective, noninvasive method that can be used to diagnose critical limb ischemia with approximately 80% accuracy.