Biomechanical Study and Orthopedic Treatment Prevent in People With Diabetic Foot

NCT04795271 | Unknown DMC

• 1 other identifier: 2020/028
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diabetic foot; Biomechanical assessment; Orthopedic treatment

Outcome Measures

Primary Outcomes (1)

• Change in the maximum plantar pressure (kPa)

  Maximum plantar pressure (kPa) detected in the baseline measurement and after 6 months of the use of orthopedic treatment

  6 months

Study Arms (1)

Orthopedic treatment

EXPERIMENTAL

Participants who are referred for orthopedic treatment as indicated by the treating traumatologist or rehabilitating doctor will be evaluated and treated by one of the three orthopedists participating in this study. After the orthopedic evaluation, the professional will determine the most suitable insole according to the plantar discharge needs required by the patient. The intervention in the insole can include modifications or corrections at the forefoot, midfoot, or hindfoot. The material used in each insole will also be specified. When the insole requires many modifications and raises the height of the subject's foot, the use of orthopedic footwear will also be added to prevent pressure on the dorsum of the foot that could be caused by normal footwear.

Other: Orthopedic intervention

Interventions

Orthopedic intervention OTHER

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.

Orthopedic treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diabetic polyneuropathy
• Metatarsalgia with hyperkeratosis and/or claw fingers with diabetic polyneuropathy
• Support abnormalities in the coronal plane (supination/pronation)
• Plantar ulcers secondary to alterations in evolving and healed plantar pressures
• Charcot foot postoperative

You may not qualify if:

• Peripheral arterial disease (absence of distal pulses or ischemia)
• Active osteomyelitis
• Patients with prostheses after amputation
• Patients who travel mainly in a wheelchair due to gait abnormalities associated with other diseases.

Sponsors & Collaborators

• University of Valencia: lead
• Instituto de Investigacion Sanitaria INCLIVA: collaborator

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Francisco Forriols Brocal, PhD.

  Orthopedic Surgery and Traumatology Service of the University Clinical Hospital of Valencia, Spain.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: All participants will receive personalized orthopedic treatment, depending on the plantar discharge needs that each patient needs. This treatment may include the use of an insole or insole and orthopedic footwear.

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: November 12, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 8, 2022

Record last verified: 2022-12

Locations

ES (1)