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Biomechanical Study and Orthopedic Treatment Prevent in People With Diabetic Foot

NCT04795271 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-12-08

No results posted yet for this study

Summary

Spain is the country with the second-highest rate of population amputation due to the development of ulcers, behind the United States, where 2 out of 3 non-traumatic amputations derive from diabetes. This is why the main objective of this project is to establish a study protocol for alterations in plantar pressures and gait abnormalities in diabetic patients, parallel to the preventive orthopedic treatment of major complications such as Charcot's foot, ulcers in the plantar support surface, and amputations. The study methodology will be based on the evaluation prior to the personalized orthopedic treatment for each patient and the evaluation after the orthopedic treatment, specifically at one week, one month, three months, and six months after the treatment. At each evaluation time, plantar pressure and reaction forces during walking and local infrared thermography will be analyzed. In the basal and final evaluation at six months, the muscular strength and range of motion of the lower limbs will also be evaluated. The orthopedic intervention is personalized to the requirements of the patients and is based on the use of an insole with the possible inclusion of orthopedic footwear in order to reduce plantar pressure.

Conditions

  • Diabetic Foot

Interventions

OTHER

Orthopedic intervention

In each custom insole, modifications can be included in the following aspects according to the requirements of each participant : 1. Forefoot specifications: a) Retrocapital bar, b) Retrocapital support, c) Claw toe correction element, d) Pronating wedge, e) Supinator wedge, f) Metatarsal head pad, g) Selective perforations in the insole, h) Others. 2. Midfoot specifications: a) Internal arch, b) External arch, c) Full support, d) Excavations, e) Others. 3. Hindfoot specifications: a) Heel cup, b) Supinator wedge, c) Pronating wedge, d) Lifter, e) Cup, f) Others. 4. Insole type and lining material 5. Materials of the added corrections 6. Insole base: a) soft ethylene vinyl acetate (eva), b) semi-soft eva, c) hard eva, d) rubber, e) cuerolite.

Sponsors & Collaborators

  • Instituto de Investigacion Sanitaria INCLIVA

    collaborator INDUSTRY

  • University of Valencia

    lead OTHER

Principal Investigators

  • Francisco Forriols Brocal, PhD. · Orthopedic Surgery and Traumatology Service of the University Clinical Hospital of Valencia, Spain.

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-12
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04795271 on ClinicalTrials.gov