Hard-to-heal diabetic foot ulcers treated using negatively charged polystyrene microspheres: a prospective case series.

OBJECTIVE: To describe the outcomes of a new product based on negatively charged polystyrene microspheres (NCM) technology, in non-responding diabetic foot ulcers (DFU). METHODS: A clinical case series of patients with a hard-to-heal DFU treated with NCM were recruited between March and June 2017 in a specialised diabetic foot unit. DFUs were treated daily with NCM over four weeks, although the health professional could decide to continue NCM treatment in some patients. Cases were followed up for 12 weeks. Wollina score (granulation, colour and consistency tissue), wound area (cm2), percentage reduction and wound closure (%) were measured. RESULTS: A total of 22 ulcers (19 patients) were included, of which three patients (five ulcers) were withdrawn due to adverse events: four infections and one necrosis. None were associated with the product. NCM treatment was completed in 17 ulcers (16 patients). The mean patient age was 61.53±9.57 years. At baseline, mean duration time of the DFU was 7.88±8.65 weeks, the median area was 5.35cm2, the interquartile range (IQR) was 1.45 to 4.65cm2 and positive probe-to-bone test (PTB+) was recorded at 29.4%. After four weeks of treatment, an increase in Wollina score (3.65±2.12 to 5.69±1.18; p=0.000), a 62.2% reduction of the ulcer area (5.35 cm2; IQR: 1.45 to 4.65cm2) to 3.33cm2 (IQR: 0.25 to 1.70cm2; p<0.001) and complete healing in 17.6% of ulcers was observed. The mean time of NCM treatment was 6.2±1.2 weeks. At 12 weeks, 100% achieved complete healing, including those ulcers with PTB+. CONCLUSION: After NCM use, a reactivation of the healing process in non-responding wounds was observed, having a significant improvement in Wollina score as well as reduction of the wounds. Complete healing was achieved in all ulcers at 12 weeks, including PTB+.

Relationship of limited joint mobility and foot deformities with neurological examination in patients with diabetes.

AIMS: The aim is to define the association of forefoot deformity and limited joint mobility in the ankle and hallux joints in patients with diabetes mellitus subject to different diagnostic tests for diabetic neuropathy. Prospective study with 118 type 2 diabetic patients (68 men, mean age of 65.6±9.9 years) enrolled consecutively from the Diabetic Foot Unit of the Complutense University of Madrid subject to evaluation of plantar surface sensitivity by 10-g Semmes-Weinstein Monofilament, vibratory threshold by biothesiometer, and sudomotor dysfunction by Neuropad®. The patients presented with limited joint mobility of the ankle and the first metatarsophalangeal joints, and forefoot deformities were registered. Statistical analysis was done through a univariate model to test the association between neurological and biomechanical alteration. There was an association of abnormal Monofilament (p=0.01; OR=3.9) and biothesiometer tests (p=0.01; OR=2.6) with the presence of forefoot deformity. Furthermore, a relation was found between abnormal Monofilament (p=0.02; OR=4.8) and biothesiometer (p<0.00; OR=12.8) tests with limited mobility of the first metatarsophalangeal joint both in loading and off-loading. Abnormal sudomotor function test was related with limited joint mobility of the ankle joint with the knee flexed (p=0.04; OR=2.8). CONCLUSIONS: The results of this study show discordance between biomechanical abnormalities and neuropathy depending on the diagnostic test used. Tests that assess large myelinated nerve fibers are associated with the presence of deformities. Abnormal sudomotor function test is associated with limited joint mobility and this test has a greater capacity for selecting patients at risk.