Back to resultsPatients With Diabetic Neuropathy Who Receive Physiotherapy Treatment Will Have a Decrease in Diabetic Foot Ulcers
Primary Purpose
Diabetic Foot Ulcer, Diabetic Neuropathy Peripheral
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physiotherapy protocol
Sponsored by
About this trial
This is an interventional prevention trial for Diabetic Foot Ulcer focused on measuring Prevention, Physiotherapy, Diabetic Foot Ulcer, Exercise Therapy, Manual Therapy
Eligibility 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.)
Sites / Locations
- Universidad Complutense de MadridRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental Group
Control Group
Arm Description
The intervention will be a progressive physiotherapy protocol formed by therapeutic exercise and manual therapy
The control group will not receive physiotherapy treatment.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Change in maximum plantar pressure
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.
Change in joint mobility
The mobility of the tibiofibular-talar joint, subtalar joint and the first metatarsophalangeal joint, both in loading and unloading, will be measured by goniometer.
Change in foot function index
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
Change in neurological function of the foot
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
Change in confidence in the balance for specific activities
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
Changes in the integral pressure-time
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).
Full Information
NCT ID
NCT03725917
First Posted
October 24, 2018
Last Updated
April 23, 2019
Sponsor
Universidad Complutense de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT03725917
Brief Title
Patients With Diabetic Neuropathy Who Receive Physiotherapy Treatment Will Have a Decrease in Diabetic Foot Ulcers
Official Title
Efficacy of a Protocol of Intervention in Physiotherapy in the Prevention of Diabetic Foot Ulcers in Patients With Diabetic Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer, Diabetic Neuropathy Peripheral
Keywords
Prevention, Physiotherapy, Diabetic Foot Ulcer, Exercise Therapy, Manual Therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Outcomes Assessor
Masking Description
All assessments will be made by an experienced Podiatrist, who will not have other functions in the study
Allocation
Randomized
Enrollment
143 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The intervention will be a progressive physiotherapy protocol formed by therapeutic exercise and manual therapy
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will not receive physiotherapy treatment.
Intervention Type
Other
Intervention Name(s)
Physiotherapy protocol
Other Intervention Name(s)
Physical therapy protocol
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in the integrity of the skin (Ulceration)
Description
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).
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
Secondary Outcome Measure Information:
Title
Change in maximum plantar pressure
Description
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.
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
Title
Change in joint mobility
Description
The mobility of the tibiofibular-talar joint, subtalar joint and the first metatarsophalangeal joint, both in loading and unloading, will be measured by goniometer.
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
Title
Change in foot function index
Description
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
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
Title
Change in neurological function of the foot
Description
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
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
Title
Change in confidence in the balance for specific activities
Description
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
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
Title
Changes in the integral pressure-time
Description
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).
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guido F Gómez Chiguano
Phone
+34 655878395
Email
guido_101@msn.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mateo López Moral
Phone
+34 652 31 15 73
Email
matlopezmor@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José L Lázaro Martínez
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Study Director
Facility Information:
Facility Name
Universidad Complutense de Madrid
City
Madrid
State/Province
Comunidad De Madrid
ZIP/Postal Code
28400
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guido F Gómez Chiguano, Physiotherapist
Phone
655878395
Email
guidogom@ucm.es
12. IPD Sharing Statement
Citations:
PubMed Identifier
12381797
Citation
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.
Results Reference
background
PubMed Identifier
27269974
Citation
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.
Results Reference
background
PubMed Identifier
24767584
Citation
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.
Results Reference
background
PubMed Identifier
10740995
Citation
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.
Results Reference
background
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Patients With Diabetic Neuropathy Who Receive Physiotherapy Treatment Will Have a Decrease in Diabetic Foot Ulcers
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