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Trial record 18 of 50045 for:    will | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03725917
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Guido Gomez Chiguano, Universidad Complutense de Madrid

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Diabetic Neuropathy Peripheral Other: Physiotherapy protocol Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Single (Outcomes Assessor)
Masking Description: All assessments will be made by an experienced Podiatrist, who will not have other functions in the study
Primary Purpose: Prevention
Official Title: Efficacy of a Protocol of Intervention in Physiotherapy in the Prevention of Diabetic Foot Ulcers in Patients With Diabetic Neuropathy
Actual Study Start Date : March 25, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Group
The intervention will be a progressive physiotherapy protocol formed by therapeutic exercise and manual therapy
Other: 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 Name: Physical therapy protocol

No Intervention: Control Group
The control group will not receive physiotherapy treatment.



Primary Outcome Measures :
  1. Change in the integrity of the skin (Ulceration) [ Time Frame: 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 ]

    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).



Secondary Outcome Measures :
  1. Change in maximum plantar pressure [ Time Frame: 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 ]
    The maximum plantar pressure of 10 areas of foot support (medial heel, lateral heel, midfoot, plantar area of each of the heads of the metatarsals from first to fifth, first toe and support area of the middle fingers from second to fifth) will be obtained through the F-Scan® system, a computerized pedobarographic analysis system. To express the maximum plantar pressure the newton per centimeter (N/cm) will be used.

  2. Change in joint mobility [ Time Frame: 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 ]
    The mobility of the tibiofibular-talar joint, subtalar joint and the first metatarsophalangeal joint, both in loading and unloading, will be measured by goniometer.

  3. Change in foot function index [ Time Frame: 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 ]

    The foot function index will be measured by adapting the Foot Function Index (FFI) Questionnaire to Spanish. The FFI is a questionnaire in which the answers are about the experience of the participant's previous week.

    It consists of 23 items divided into 3 subscales: pain, disability and limitation of activity. For each item there is an visual analog scale with values from 0 to 10. If the respondents do not find the question appropriate, they can leave it blank. Once the questionnaire is completed, all the points are added and divided by the maximum score that can be achieved with the items that have been filled out. The result obtained from each subscale is multiplied by one hundred, and rounded if necessary, to obtain values between zero and one hundred, the higher the value, the worse the patient's condition will be. The total function is obtained by calculating the average of the 3 subscale


  4. Change in neurological function of the foot [ Time Frame: 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 ]
    Neurological function of the foot will be assessed using the Neuropathy Disability Score (NDS) instrument. The neurological function of the foot will be assessed using the NDS instrument. This allows the global assessment of neuropathy, by evaluating both long nerve fibers, which intervene in reflexes and vibratory sensitivity; as short fibers, involved in sensitivity to pain and temperature. It consists of a standardized examination of ankle reflexes and the perception of some sensory tests: pain, temperature and vibration. The minimum score of the NDS is 0 and the maximum score is 10, 5 in each leg. A score of 10 points indicates the complete loss of sensitivity and the absence of tendon reflexes. An NDS score ≥ 6/10 has a 2.3 times higher risk of developing a new ulcer in a 2-year follow-up period than those with a score of ≤ 5/10

  5. Change in confidence in the balance for specific activities [ Time Frame: 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 ]

    Confidence and balance in specific activities will be assessed by adapting the ´´Activities Specific Balance Confidence Scale (ABC)`` to Spanish.

    The ABC scale is a 16-item questionnaire that assesses the level of confidence when performing a specific task without losing balance or becoming unstable. The score of each item varies between 0% (No confidence) and 100% (Total confidence). The final score is obtained by adding the value of each item, and dividing it by 16


  6. Changes in the integral pressure-time [ Time Frame: 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 ]
    The integral pressure-time of 10 areas of foot support (medial heel, lateral heel, midfoot, plantar area of each of the heads of the metatarsals from first to fifth, first toe and support area of the middle fingers from second to fifth) will be obtained through the F-Scan® system, a computerized pedobarographic analysis system. To express the integral pressure-time the newton second per centimenter will be used (N.S/cm).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03725917


Contacts
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Contact: Guido F Gómez Chiguano +34 655878395 guido_101@msn.com
Contact: Mateo López Moral +34 652 31 15 73 matlopezmor@hotmail.com

Locations
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Spain
Universidad Complutense de Madrid Recruiting
Madrid, Comunidad De Madrid, Spain, 28400
Contact: Guido F Gómez Chiguano, Physiotherapist    655878395    guidogom@ucm.es   
Sponsors and Collaborators
Universidad Complutense de Madrid
Investigators
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Study Director: José L Lázaro Martínez Universidad Complutense de Madrid

Publications:
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Responsible Party: Guido Gomez Chiguano, Clinical Research, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT03725917     History of Changes
Other Study ID Numbers: V2.0_16.07.18
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guido Gomez Chiguano, Universidad Complutense de Madrid:
Prevention
Physiotherapy
Diabetic Foot Ulcer
Exercise Therapy
Manual Therapy

Additional relevant MeSH terms:
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Ulcer
Diabetic Foot
Foot Ulcer
Diabetic Neuropathies
Peripheral Nervous System Diseases
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Foot Diseases
Neuromuscular Diseases
Nervous System Diseases