Patients With Diabetic Neuropathy Who Receive Physiotherapy Treatment Will Have a Decrease in Diabetic Foot Ulcers
NCT ID: NCT03725917
Last Updated: 2019-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
143 participants
INTERVENTIONAL
2019-03-25
2019-12-01
Brief Summary
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Detailed Description
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In previous studies, it has been observed that physiotherapy protocols have produced improvements in joint mobility, magnitude of plantar pressures, distribution of plantar pressures, and improved function in the ankle and foot.
A 12-week progressive physiotherapy protocol composed of manual therapy and exercise could produce changes in foot and ankle characteristics in diabetic neuropathic patients related to tissue damage, resulting in a reduction in ulcerations.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Experimental Group
The intervention will be a progressive physiotherapy protocol formed by therapeutic exercise and manual therapy
Physiotherapy protocol
The intervention will consist of a physiotherapy protocol twice a week for twelve weeks. The protocol will be done in three phases, constituting each month, a phase of the protocol. The first two phases will include therapeutic exercise of progressive difficulty and manual therapy, while the last phase will include only one week of manual therapy and therapeutic exercise, the last three weeks being composed only of therapeutic exercise
Control Group
The control group will not receive physiotherapy treatment.
No interventions assigned to this group
Interventions
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Physiotherapy protocol
The intervention will consist of a physiotherapy protocol twice a week for twelve weeks. The protocol will be done in three phases, constituting each month, a phase of the protocol. The first two phases will include therapeutic exercise of progressive difficulty and manual therapy, while the last phase will include only one week of manual therapy and therapeutic exercise, the last three weeks being composed only of therapeutic exercise
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with diabetic neuropathy
* Patients with no previous history of ulcers
* Patients with no previous history of lower limb amputations
Exclusion Criteria
* Severe vascular complications (arterial or venous ulcers)
* Patients with critical ischemia
* Patient who need walking aids (canes, crutches, splints etc.)
* Patients with a history of neuropathy with different etiology from diabetes mellitus.
* Patients with peripheral nervous lesions (traumatic origin, associated with surgical procedures, compression of spinal roots, plexus palsy, herpes zoster, polyradiculopathy, etc.)
18 Years
ALL
No
Sponsors
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Universidad Complutense de Madrid
OTHER
Responsible Party
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Guido Gomez Chiguano
Clinical Research
Principal Investigators
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José L Lázaro Martínez
Role: STUDY_DIRECTOR
Universidad Complutense de Madrid
Locations
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Universidad Complutense de Madrid
Madrid, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Goldsmith JR, Lidtke RH, Shott S. The effects of range-of-motion therapy on the plantar pressures of patients with diabetes mellitus. J Am Podiatr Med Assoc. 2002 Oct;92(9):483-90. doi: 10.7547/87507315-92-9-483.
Cerrahoglu L, Kosan U, Sirin TC, Ulusoy A. Range of Motion and Plantar Pressure Evaluation for the Effects of Self-Care Foot Exercises on Diabetic Patients with and Without Neuropathy. J Am Podiatr Med Assoc. 2016 May;106(3):189-200. doi: 10.7547/14-095.
Sartor CD, Hasue RH, Cacciari LP, Butugan MK, Watari R, Passaro AC, Giacomozzi C, Sacco IC. Effects of strengthening, stretching and functional training on foot function in patients with diabetic neuropathy: results of a randomized controlled trial. BMC Musculoskelet Disord. 2014 Apr 27;15:137. doi: 10.1186/1471-2474-15-137.
Dijs HM, Roofthooft JM, Driessens MF, De Bock PG, Jacobs C, Van Acker KL. Effect of physical therapy on limited joint mobility in the diabetic foot. A pilot study. J Am Podiatr Med Assoc. 2000 Mar;90(3):126-32. doi: 10.7547/87507315-90-3-126.
Other Identifiers
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V2.0_16.07.18
Identifier Type: -
Identifier Source: org_study_id
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