Impact of Therapeutic Footwear and Plantar Orthoses on Diabetic Neuropathic Foot in Quality of Life and Functionality

Universidade do Algarve

Status: Completed

Conditions: Diabetes Mellitus, Type 2; Diabetic Peripheral Neuropathy

Treatments: Device: Plantar Orthoses; Behavioral: Education on foot self-care; Device: Orthopedic Footwear; Device: Standard Footwear

Study type: Interventional

Funder types: Other

Identifiers

NCT04605900

0348_CIE_6_E

Details and patient eligibility

About

This study determines the effectiveness of plantar orthoses and custom-made orthopedic footwear in functional level and quality of life of persons with diabetes type 2 and diabetic peripheral neuropathy. This study is important due the loss of protective sensation, feet are vulnerable to minor trauma caused by plantar pressure as well as mechanical and thermal injuries. Thus, Plantar Orthoses become necessary to reduce PP and align the foot. Additionally, it is known that footwear is the most frequent cause of diabetic foot injury, since ulceration is frequently a consequence of the continuous trauma provoked by inadequate footwear. For a higher efficacy in the treatment of the foot, it is also necessary to use custom-made orthopedic footwear, indicated in the treatment of foot pathologies.

The lack of studies that evaluate the impact of this treatment on clinical measures such as quality of life and functional level, led to the development of this study, comparing a standard treatment (standard footwear and plantar orthoses) with an optimal treatment suggested in diabetic foot guidelines (therapeutic footwear and plantar orthoses).

Full description

This clinical trial includes 2 parallel intervention groups with a pre- and post-test analysis. In the standard footwear (SF) group, plantar orthoses, standard footwear and education on foot self-care were applied and in the orthopedic footwear (OF) group the same intervention was applied, but with orthopedic footwear.

Both intervention groups were evaluated at two different time points, with the pre-test taking place at the beginning of the study (T0 - Baseline) and the post-test taking place 4 months after the application of the treatment (T4). In the middle of the study, at two months (T2) a questionnaire was applied in order to understand the adherence and the perception of individuals about the intervention applied.

The screening of diabetic peripheral neuropathy was made with the Michigan Neuropathy Screening Instrument (MNSI) and the description of the sample with an evaluation questionnaire.

The FL was evaluated through the Lower Extremity Functional Scale (LEFS), physical tests and the postural, static and dynamic barometric assessment. QoL was assessed with SF-36 and the adherence and satisfaction with a questionnaire created ad hoc.

Enrollment: 43 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of type 2 DM;
• Have at least 6 months from diagnosis of DM;
• Presence of Diabetic Polyneuropathy;
• No history of plantar orthoses and orthopedic footwear use.

Exclusion criteria

• Active ulceration;
• Severe osteoarticular deformities;
• Presence of cognitive impairment;
• Gait with technical devices;
• Diagnosis of neurological pathology that can affect the gait pattern;
• Diagnosis of another pathology that can negatively influence the study: depression, the presence of uncontrolled cardiovascular diseases and active cancer.
• Surgical interventions on the spine and lower limbs, with less than 1 year of recovery.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

43 participants in 2 patient groups

Standard Footwear (SF)

Experimental group

Description:

Intervention: plantar orthoses, education on foot self-care and appropriate standard footwear.

Treatment:

Device: Plantar Orthoses

Behavioral: Education on foot self-care

Device: Standard Footwear

Orthopedic Footwear (OF)

Experimental group

Description:

Intervention: plantar orthoses, education on foot self-care and orthopedic footwear.

Treatment:

Device: Plantar Orthoses

Device: Orthopedic Footwear

Behavioral: Education on foot self-care