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Biomechanical Study and Orthopedic Treatment Prevent in People With Diabetic Foot (FOOTprevent)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04795271
Recruitment Status : Recruiting
First Posted : March 12, 2021
Last Update Posted : March 12, 2021
Information provided by (Responsible Party):
Constanza San Martín, University of Valencia

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Other: Orthopedic intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Biomechanical Study of Patients With Diabetic Foot for the Establishment of a Preventive Orthopedic Treatment Protocol for Major Complications
Actual Study Start Date : November 12, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Orthopedic treatment

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

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.

Primary Outcome Measures :
  1. Change in the maximum plantar pressure (kPa) [ Time Frame: 6 months ]
    Maximum plantar pressure (kPa) detected in the baseline measurement and after 6 months of the use of orthopedic treatment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04795271

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Contact: Francisco Forriols Brocal, PhD. (+34) 961925415
Contact: Constanza San Martín, PhD. (+34) 963864768

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University of Valencia Recruiting
Valencia, Spain, 46010
Contact: Francisco Forriol Brocal, PhD.    (+34) 961925415   
Contact: Constanza San Martín Valenzuela, PhD.    (+34) 963864768   
Sponsors and Collaborators
University of Valencia
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Principal Investigator: Francisco Forriols Brocal, PhD. Orthopedic Surgery and Traumatology Service of the University Clinical Hospital of Valencia, Spain.
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Responsible Party: Constanza San Martín, Researcher, University of Valencia Identifier: NCT04795271    
Other Study ID Numbers: 2020/028
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: All data obtained through this study will be shared with the scientific community and with other researchers through scientific publications generated from this study. The principal investigators are totally open to answering questions and providing data that have previously been published if other investigators so request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Constanza San Martín, University of Valencia:
Diabetic foot
Biomechanical assessment
Orthopedic treatment
Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies