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Patients With Diabetic Neuropathy Who Receive Physiotherapy Treatment Will Have a Decrease in Diabetic Foot Ulcers

U

Universidad Complutense de Madrid

Status

Unknown

Conditions

Diabetic Foot Ulcer
Diabetic Neuropathy Peripheral

Treatments

Other: Physiotherapy protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT03725917
V2.0_16.07.18

Details and patient eligibility

About

This study evaluates the effects of a physiotherapy protocol (manual therapy and exercise) in the prevention of diabetic foot ulcers in patients with diabetic neuropathy. A group of participants will receive a physiotherapy protocol added to their usual medical treatment and the other group will not receive physiotherapy treatment.

Full description

Neuropathic diabetic patients present alterations in joint mobility, plantar pressures and ankle and foot function, characteristics related to the development of ulcers.

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.

Enrollment

143 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants with diabetes mellitus type 1 or type 2
  • Patients with diabetic neuropathy
  • Patients with no previous history of ulcers
  • Patients with no previous history of lower limb amputations

Exclusion criteria

  • Patients with neurological or orthopedic problems that make walking difficult (spasticity, cerebral palsy, poliomyelitis, rheumatoid arthritis)
  • 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.)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

143 participants in 2 patient groups

Experimental Group
Experimental group
Description:
The intervention will be a progressive physiotherapy protocol formed by therapeutic exercise and manual therapy
Treatment:
Other: Physiotherapy protocol
Control Group
No Intervention group
Description:
The control group will not receive physiotherapy treatment.

Trial contacts and locations

1

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Central trial contact

Guido F Gómez Chiguano; Mateo López Moral

Data sourced from clinicaltrials.gov

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