This Research Hypothesizes That the Use of a Rigid Rocker Sole Reduces the Recurrence Rate of Diabetic Foot Ulcers in Patients With Peripheral Neuropathy.
Clinical Efficacy of Therapeutic Footwear With a Rigid Rocker Sole in the Prevention of Reulceration in Patients With Diabetes Mellitus and Diabetic Polineuropathy: a Prospective and Randomized Clinical Trial.
1 other identifier
interventional
73
1 country
1
Brief Summary
This research presents a randomized clinical trial which analyzes the efficacy of a rigid rocker sole in the reduction of the recurrence rate of plantar ulcers in diabetic foot patients. The hypothesis of the research is the use of a rigid rocker sole reduces the recurrence rate of diabetic foot ulcers in patients with peripheral neuropathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 10, 2016
CompletedFirst Submitted
Initial submission to the registry
December 12, 2016
CompletedFirst Posted
Study publicly available on registry
December 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2018
CompletedMay 16, 2018
May 1, 2018
1 year
December 12, 2016
May 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Presence of diabetic foot ulcer
The Wagner system assesses ulcer depth and the presence of osteomyelitis or gangrene using the following grades: grade 0 (pre- or post-ulcerative lesion), grade 1 (partial/full-thickness ulcer), grade 2 (probing to tendon or capsule), grade 3 (deep with osteitis), grade 4 (partial foot gangrene) and grade 5 (whole foot gangrene
through study completion, an average of 6 months
Secondary Outcomes (10)
Ankle Joint movility
through study completion, an average of 6 months
Mobility of the First metatarsal Joint
through study completion, an average of 6 months
Subtalar Joint Movements
through study completion, an average of 6 months
IPAQ (International Physical Activity Questionnaires)
through study completion, an average of 6 months
Foot Type
through study completion, an average of 6 months
- +5 more secondary outcomes
Study Arms (2)
Experimental Group
EXPERIMENTALRigid rocker sole footwear
Control Group
ACTIVE COMPARATORTherapeutic footwear
Interventions
Eligibility Criteria
You may qualify if:
- Type 1 or 2 diabetic patients regardless of the pharmacotherapy that they receive.
- Adult patients of both sexes.
- Peripheral neuropathy patients.
- Patients without wounds or ulcers at the examination time.
- Patients with a foot ulcers history.
- Patients who don´t need gait support mechanisms such as walking sticks, crutches, splints or any other devices which interferes with the autonomous development of the gait.
You may not qualify if:
- Patients with mayor amputation.
- Patients with rheumatic disease that affect the feet.
- Patients with peripheral neuropathy of different etiology to Diabetes mellitus.
- Patients with several critical ischemia criteria, defined by TACS II guideline.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clínica Universitaria de Podología de la Universidad Complutense de Madrid
Madrid, 28040, Spain
Related Publications (1)
Lopez-Moral M, Lazaro-Martinez JL, Garcia-Morales E, Garcia-Alvarez Y, Alvaro-Afonso FJ, Molines-Barroso RJ. Clinical efficacy of therapeutic footwear with a rigid rocker sole in the prevention of recurrence in patients with diabetes mellitus and diabetic polineuropathy: A randomized clinical trial. PLoS One. 2019 Jul 11;14(7):e0219537. doi: 10.1371/journal.pone.0219537. eCollection 2019.
PMID: 31295292DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Research
Study Record Dates
First Submitted
December 12, 2016
First Posted
December 19, 2016
Study Start
December 10, 2016
Primary Completion
December 10, 2017
Study Completion
May 10, 2018
Last Updated
May 16, 2018
Record last verified: 2018-05