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No subsequent RCTs have been found which analyse the impact on the complications
of diabetic foot. In an RCT carried out in primary care centres (251), a
structured program which was revised on an annual basis, identified and treated
patients at high risk, improved the knowledge and attitudes of patients and professionals
as well as the use of services.
In contexts different to the one presented in this guideline, there are several
studies with less solid design, such as before-after studies (252) or prospective
studies (253) which assess the impact of programs that include screening, risk
stratification, preventive and treatment measures depending on the risk and which
have proved to reduce the incidence of amputations. In these studies screening
is carried out by chiropodists and trained nursing staff, who normally belong to
multidisciplinary teams, or by foot or diabetes specialized units with structured
programs.
In the studies reviewed (250; 253), the following methods were used to identify
patients at high risk:
• Close visual inspection of the foot to identify deformities, hyperkeratosis,
inappropriate footwear or the existence of prior amputations.
• Arteriopathy evaluation: observation of the skin colouring, temperature,
presence of pulses, pain when walking, determination of the ankle-arm
index.
• Sensory neuropathy evaluation through the monofilament test.
The NICE guideline (246) recommends the classification of the risk into four
categories depending on the risk factors.
Observational
studies
2+
CPG
4
Table 11. Classification of diabetic foot risk. Recommended frequency of inspection
Risk
(Classification)
Low risk
Characteristics
Maintained sensitivity, palpable
pulses
Annual
Frequency of inspection
Increased risk
High risk
Ulcerate foot
Neuropathy, absence of pulses or
any other risk factor
Neuropathy or absent pulses
together with deformity or
changes in the skin
Ulcerate foot
Every 3-6 months
Every 1-3 months
Individualized treatment, possible
referral
In Spain, the implementation of these interventions can be limited. The screening
and risk stratification activities are feasible, though there are no equivalent and
structured facilities to refer to and treat the foot at risk, as these vary among the
different Autonomous Communities. The current barriers to implement appropriate
diabetic foot prevention and treatment are mainly a lack of organization and
training.
102 CLINICAL PRACTICE GUIDELINES IN THE NHS