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

NCT03725917 | Unknown

• 1 other identifier: V2.0_16.07.18
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Foot Ulcer; Diabetic Neuropathy Peripheral

Keywords

Prevention; Physiotherapy; Diabetic Foot Ulcer; Exercise Therapy; Manual Therapy

Outcome Measures

Primary Outcomes (1)

• Change in the integrity of the skin (Ulceration)

  An ulcer is considered a full thickness wound below the ankle in a diabetic patient, regardless of duration, including gangrene and necrosis. The evaluator will review the patient's medical records on the day of the evaluations, in order to assess if there has been an ulceration in the periods between evaluations and also perform a foot exploration to assess if the ulcer is present on the day of measurement. 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).

  Clinical evaluation will be conducted at pre-treatment, post- treatment 12 weeks, post- treatment 24 weeks, post- treatment 36 weeks, post- treatment 48 weeks and post- treatment 60 weeks

Secondary Outcomes (6)

• Change in maximum plantar pressure

  Clinical evaluation will be conducted at pre-treatment, post- treatment 12 weeks, post- treatment 24 weeks, post- treatment 36 weeks, post- treatment 48 weeks and post- treatment 60 weeks

• Change in joint mobility

  Clinical evaluation will be conducted at pre-treatment, post- treatment 12 weeks, post- treatment 24 weeks, post- treatment 36 weeks, post- treatment 48 weeks and post- treatment 60 weeks

• Change in foot function index

  Clinical evaluation will be conducted at pre-treatment, post- treatment 12 weeks, post- treatment 24 weeks, post- treatment 36 weeks, post- treatment 48 weeks and post- treatment 60 weeks

• Change in neurological function of the foot

  Clinical evaluation will be conducted at pre-treatment, post- treatment 12 weeks, post- treatment 24 weeks, post- treatment 36 weeks, post- treatment 48 weeks and post- treatment 60 weeks

• Change in confidence in the balance for specific activities

  Clinical evaluation will be conducted at pre-treatment, post- treatment 12 weeks, post- treatment 24 weeks, post- treatment 36 weeks, post- treatment 48 weeks and post- treatment 60 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

The intervention will be a progressive physiotherapy protocol formed by therapeutic exercise and manual therapy

Other: Physiotherapy protocol

Control Group

NO INTERVENTION

The control group will not receive physiotherapy treatment.

Interventions

Physiotherapy protocol OTHER

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

Also known as: Physical therapy protocol

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Universidad Complutense de Madrid

Madrid, Madrid, 28400, Spain

RECRUITING

Related Publications (4)

• 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.

  PMID: 12381797 BACKGROUND

• 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.

  PMID: 27269974 BACKGROUND

• 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.

  PMID: 24767584 BACKGROUND

• 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.

  PMID: 10740995 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• José L Lázaro Martínez

  Universidad Complutense de Madrid

  STUDY DIRECTOR

Central Study Contacts

Guido F Gómez Chiguano

CONTACT

+34 655878395; guido_101@msn.com

Mateo López Moral

CONTACT

+34 652 31 15 73; matlopezmor@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All assessments will be made by an experienced Podiatrist, who will not have other functions in the study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 31, 2018
• Study Start: March 25, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 24, 2019

Record last verified: 2019-04

Locations

ES (1)