BACKGROUND: The aim of this study was the clinical evaluation of an original device produced to evaluate edema in a semi-quantitative way, the ACI Medical, Edema Tester (ET). ET1, is a soft plastic plate characterised by two parallel conic pyramidal protrusions. One side of the protrusion is rounded while the other side has an angular edge. The two protrusions are placed on the plate in inverse decreasing height. ET2 is characterised by two lines of 7 holes placed in the plate. The ET is applied at the internal perimalleolar region with the conic pyramidal protrusions in contact with the skin. A standard sphygmomanometer cuff is applied over the area and pressure is maintained at 50 mmHg for a period between 1 an 3 minutes. The cuff is then removed. ET1: skin marks are usually just visible in normal subjects without edema and disappear in a few minutes. When edema is moderate some half of each protrusion is visible as a skin mark. In limbs with severe edema the whole length of the protrusion is clearly visible. ET2: skin marks are usually just visible in normal limbs without edema and disappear in a few minutes. In limbs with edema the number of holes visible on the skin is increased and in severe edema all holes are visible. METHODS: To evaluate semi-quantitatively the level of edema the length of the two skin marks can be measured and for the ET2 the numbers of visible holes can be counted, as they are generally proportional to the degree of edema. The ET testers were evaluated in 22 normal subjects, 19 limbs with varicose veins, 22 patients with CVI and lipodermatosclerosis, 5 patients with initial primary lymphedema and in 8 subjects with severe, chronic, lymphedema and skin alterations. RESULTS: The results showed a significant difference between normal limbs an patients. CONCLUSIONS: In conclusion, the method of evaluating edema with ET can be used to supplement the clinical and noninvasive evaluation. In general practice the presence of edema measurable with ET indicate the need for treatment. The several degrees of skin marks visibility and disappearance time may be used as a general guideline to indicate the need for different types and length of treatment.
BACKGROUND: The aim of this study was the clinical evaluation of an original device produced to evaluate edema in a semi-quantitative way, the ACI Medical, Edema Tester (ET). ET1, is a soft plastic plate characterised by two parallel conic pyramidal protrusions. One side of the protrusion is rounded while the other side has an angular edge. The two protrusions are placed on the plate in inverse decreasing height. ET2 is characterised by two lines of 7 holes placed in the plate. The ET is applied at the internal perimalleolar region with the conic pyramidal protrusions in contact with the skin. A standard sphygmomanometer cuff is applied over the area and pressure is maintained at 50 mmHg for a period between 1 an 3 minutes. The cuff is then removed. ET1: skin marks are usually just visible in normal subjects without edema and disappear in a few minutes. When edema is moderate some half of each protrusion is visible as a skin mark. In limbs with severe edema the whole length of the protrusion is clearly visible. ET2: skin marks are usually just visible in normal limbs without edema and disappear in a few minutes. In limbs with edema the number of holes visible on the skin is increased and in severe edema all holes are visible. METHODS: To evaluate semi-quantitatively the level of edema the length of the two skin marks can be measured and for the ET2 the numbers of visible holes can be counted, as they are generally proportional to the degree of edema. The ET testers were evaluated in 22 normal subjects, 19 limbs with varicose veins, 22 patients with CVI and lipodermatosclerosis, 5 patients with initial primary lymphedema and in 8 subjects with severe, chronic, lymphedema and skin alterations. RESULTS: The results showed a significant difference between normal limbs an patients. CONCLUSIONS: In conclusion, the method of evaluating edema with ET can be used to supplement the clinical and noninvasive evaluation. In general practice the presence of edema measurable with ET indicate the need for treatment. The several degrees of skin marks visibility and disappearance time may be used as a general guideline to indicate the need for different types and length of treatment.