2.1.Design and subjects
Patients with both types of diabetes mellitus who are registered with primary health care physicians during 2014 were the subject of this cross-sectional study. The sample of 100 patients who entered the study consecutively consisted of patients from ten primary health care clinics who were seen for their insulin needs or for their oral hypoglycemic medication management. The survey included medical records review, interview for the sake of detailed with the medical history , as well as measurement and testing of the patients. Medical records were the source of personal data, data on the type of DM, duration and management of the disease up to date, and HbA1c values not older than six months. [18,19]. The clinical examinations were performed routinely by the same examiner.
2.2.Diabetc foot risk assessment
Using the data obtained from comprehensive examinations and the history taking, the patients were classified into risk categories applying IWGDF Guidelines 2019 stratification risk system as follows: the risk category 0 - patients with normal findings; the risk category 1 (low risk) -patients with LOPS or PAD; the risk category 2 (moderate risk) - patients with LOPS + PAD, or LOPS + foot deformity or PAD + foot deformity; the risk category 3 (high risk) - patients who had LOPS or PAD, and one or more of the following: history of a foot ulcer, lower-extremity amputation, and end-stage renal disease [17].
LOPS was assessed as follows: vibration testing using a 128-Hz tuning fork, tests of pinprick sensation on the dorsum of foot, tactile sensation test using cotton wool on the dorsum of foot, and Achilles ankle reflex assessment [20,21]. Vibratory sensation was tested over the tip of the great toe bilaterally. Abnormal vibratory sensation was defined as a situation when the patient loses vibratory sensation while the examiner still perceives it with a 128-Hz tuning fork on the tip of the toe. A disposable pin was applied just proximal to the toenail on the dorsal surface of the hallux, with just enough pressure to deform the skin. The inability to perceive pinprick over either hallux was considered to be an abnormal test result. Ankle reflexes were tested using the tendon hammer, with the patient kneeling on a chair. Absence of ankle reflex either at rest or upon the reinforcement, was regarded as an abnormal result [22]. Inability to perceive the cotton wool touch on the dorsal surface of the foot was regarded as an abnormal test result. One or more abnormal tests would suggest LOPS, while at least two regular tests (and no abnormal test) would rule out LOPS [20].
Vascular examination included palpation of the posterior tibial and dorsalis pedis pulses bilaterally, which was characterized as either “present” or “absent” [22-24]. The presence of two or less of the four pedal pulses indicated PAD [23]. In patients with amputations, the result on the one leg counted twice.
2.3.Foot strenght assessment
Foot and ankle muscle function were evaluated with manual muscle testing (MMT) on the dominant leg. The same scoring system, which is used in the MDNS, was applied [18,25,26]. MMT indicates the ability of the tested muscle to produce an active movement against the examiner’s resistance. MMT was done on a dominant leg. Score 0 was for normal muscle strength, 1 for mild, 2 for severe muscle weakness, and 3 for complete loss of muscle strength. As described, the muscle score (MS) was obtained for each set of muscles that were examined. The minimum score was 0 (normal strength in 10 muscles) and the maximum score was 30 (complete loss of strength in 10 muscles). Higher scores indicated increased muscle weakness [25,27]. In described testing positions, the manual clinical assessment [28] was performed for the following muscles: triceps surae, tibialis anterior, interosseus, lumbrical, flexor hallucis brevis, extensor digitorum brevis, extensor digitorum longus, flexor digitorum brevis, extensors hallucis longus, and extensor hallucis brevis [8].
2.4.Range of motion measurement
The joint mobility at the ankle joint (AJ), subtalar joint (SJ), and first metatarsophalangeal joint (I MTP) was determined using a goniometer on the dominant lower limb [29,30]. ROM at the AJ was measured with the patient in a supine position. The passive maximum range of talar flexion and extension were measured and the sum of the two values was recorded as ROM at the AJ [29]. The ROM at SJ was measured with the patient in a prone position. The maximum range of calcaneal inversion and eversion were measured and added up to indicate the ROM at the SJ. The range of passive extension to plantar flexion at the I MTP was measured with the patient supine and the ROM at the I MTP was recorded as the sum of those two values [29,30].
2.5.Foot deformities assessment
The presence of deformities such as hammer toes, claw toes, prominent metatarsal heads, and high medial arch were assessed using a foot deformity score. Hammer toes were defined as “a hyperextended metatarsophalangeal joint with a flexion deformity of the proximal interphalangeal joint and hyperextension of the distal interphalangeal joint”. Claw toes were defined as “hyperextension of the metatarsophalangeal joints and flexion of the proximal and distal interphalangeal joints”. Prominent metatarsal heads were defined as “any palpable plantar prominences of the metatarsal site of the foot”. Lastly, high medial arch was defined as “an abnormally high medial longitudinal arch”. A point was given for each deformity present to whatever degree, with a maximum score of 6 (3 for one leg) because subject could only score for one of the toe deformities. In patients with amputations, the result on the one leg counted twice [25,27]. Patient was defined as having a deformity if he/she had a score of 2 or more.
2.6. Statistical analyses
The statistical analyses were done using the software package "IBM SPSS Statistics". For a statistical analysis continuous data were presented as means and standard deviations. To test the statistical significance between variables, the one-way ANOVA test were applied. The cut off for the significance of the results was p<0.05.