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Effectiveness of Corrective Insoles in the treatment of Diabetic Foot

Efficacy of Customized Insoles in the treatment of Diabetic Foot: Randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5nqk4k
Enrollment
Unknown
Registered
2019-03-28
Start date
2019-01-05
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

In the Intervention group, a customized insole will be made with the objective of minimizing noxious plantar pressures detected in podobarography. In the control group, the insoles will be made withou
Device

Sponsors

Universidade Estadual de Ponta Grossa
Lead Sponsor
Universidade Estadual de Ponta Grossa
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Volunteers over 18 years of age; of both sexes; patients with type 2 diabetes mellitus; carriers of typical diabetic neuropathy; with increased plantar pressure in the forefoot region.

Exclusion criteria

Exclusion criteria: Patients with fasting glycemia below 100 mg / dl and HbA1c below 5.7% in the absence of treatment; patients with movement disorders; previous history of stroke; orthopedic surgeries or ulceration and amputation of lower limbs; pregnant women; patients in whom complete and adequate physical examination was not possible; patients with balance difficulties; patients who can not move alone; patients who have another cause of neuropathy; patients who do not attend for laboratory or non-laboratory tests and who choose to give up the research.

Design outcomes

Primary

MeasureTime frame
To compare the pressure points in the foot of patients with diabetic neuropathy by means of podobarography in the patients of the intervention and control group at the moment of the evaluation, and after 3 and 6 months.

Secondary

MeasureTime frame
To evaluate the foot functionality in the activities of daily living through the FAAM (Foot and Ankle Ability Measure) questionnaire.

Countries

Brazil

Contacts

Public ContactComissão de Ética em Pesquisa

Universidade Estadual de Ponta Grossa

coep@uepg.br+55-04232203108

Outcome results

None listed

Source: REBEC (via WHO ICTRP)