Effect of Whole-body Vibration on TcPO2
WBV
Intervention Project for Diabetic Foot Prevention Through the Development of a Vibratory Therapy Program at the National Rehabilitation Institute LGII
2 other identifiers
interventional
80
1 country
1
Brief Summary
In order to determine the effect of whole body vibration on TcPO2 levels in patients with type 2 diabetes, 40 subjects will undertake whole body vibration exercise three times a week for 12 weeks. TcPO2 will be measured before and after the intervention. A second control group with type 2 diabetes will also have TcPO2 levels measured before and after the 12 weeks of the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes-mellitus-type-2
Started Apr 2017
Longer than P75 for phase_3 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 4, 2017
CompletedFirst Submitted
Initial submission to the registry
May 17, 2019
CompletedFirst Posted
Study publicly available on registry
May 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedAugust 26, 2019
August 1, 2019
2.7 years
May 17, 2019
August 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Effect of whole body vibration on TcPO2 levels
To know the effect of whole body vibration on TcPO2 levels measured in the foot in patients with type 2 diabetes
12 weeks
Study Arms (2)
Controls
NO INTERVENTIONSubjects under treatment for diabetes will receive the standard treatment for their condition.
Intervention
EXPERIMENTALSubjects under treatment for diabetes not diagnosed for diabetic foot will receive the standard treatment plus exercise on a vibrator platform for a period of 12 weeks.
Interventions
Intervention will consist of sessions of exercise on a whole body vibration platform, three times a week for 12 weeks.
Eligibility Criteria
You may qualify if:
- Non-smokers.
- Residents of Mexico City
- Both sexes.
- to 69 years old.
- Agreeing to participate through signature of informed consent.
- HbA1c between 6.0 and 9.0 %.
- Blood pressure less than or equal to130/80.
- Total cholesterol ≤ 240 mg/dL, triglycerides ≤300 mg/dL.
- Stable weight over the last 6 months ( \<10% variation).
You may not qualify if:
- With exposed lesions in subcutaneous tissue (ulcers) in the sole of the foot, diabetic foot (Wagner 3 or more) or intermittent claudication.
- With important alterations in balance.
- With a recent surgery.
- Gravidity.
- Deep venous thrombosis.
- With pacemaker.
- Recent myocardial ischemia.
- Orthopedic implants.
- Recently-placed mammary prosthesis.
- Exoskeletal prosthesis.
- Discopathies.
- Neoplasia in the last 5 years.
- History of 2 episodes of severe hypoglycemia in the last year.
- Chronic kidney disease with creatinine clearance estimated at \<60 ml/min.
- Severe non-proliferative retinopathy, uncontrolled macular edema.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Nacional de Rehabilitacion
Mexico City, Mexico City, 14389, Mexico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Science Researcher
Study Record Dates
First Submitted
May 17, 2019
First Posted
May 21, 2019
Study Start
April 4, 2017
Primary Completion
December 20, 2019
Study Completion
June 1, 2020
Last Updated
August 26, 2019
Record last verified: 2019-08