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Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence

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ClinicalTrials.gov Identifier: NCT04624516
Recruitment Status : Completed
First Posted : November 10, 2020
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Maria Suryani, St Elisabeth School Health Science

Brief Summary:
The incidence of diabetic foot ulcer recurrence in one year can reach 35%. Plantar foot diabetic foot ulcer is the most frequently diabetic foot ulcer recurrence. The recurrence incidence can occur at least 14 days after the diabetic foot ulcer has healed. Physical activity and exercise are highly recommended for the prevention of diabetic foot ulcers. The study about the form of foot exercise to prevent a diabetic foot ulcer recurrence is still unclear. The major hypothesis was there is an effect of self-structured foot exercise on the plantar foot diabetic ulcer recurrences. The minor hypothesis was (1) The improvement of HbA1c, ABI, diabetic neuropathy examination score, callus, and walking speed can decrease the incidence of plantar foot diabetic ulcer (2) a self-structured foot exercise can decrease the incidence and the speed of incidence plantar doot diabetic ulcer recurrence. Participants were randomized into two groups: Exercise group (n=25) and control group (n=25). The exercise is the combination of flexibility and resistance exercise using a flexible band in 24 weeks. The incidence of plantar diabetic foot ulcers was monitored through the research process.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Diabetic Foot Other: self-structured foot exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The exercise group was trained structured foot exercise and they did the exercise independently until 24 weeks or until the recurrence occurred The control group had usual care
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The investigator didn't know the groups. The assessor didn't know the groups
Primary Purpose: Prevention
Official Title: Effect of Self-structured Foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence Post Healing at Least One Month
Actual Study Start Date : September 4, 2019
Actual Primary Completion Date : July 30, 2020
Actual Study Completion Date : July 30, 2020

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Arm Intervention/treatment
Experimental: Intervention group
The group received training in self-structured foot exercise and they were encouraged to do self-structure foot exercise 3 times a week. They received usual care
Other: self-structured foot exercise
The exercise was done 3 times a week (15x/until they tired x 2set). The exercise used a flexible band with difference thickness (0,5 mm in the first 12 weeks and 0,65 mm in the second 12 weeks)
Other Names:
  • foot exercise
  • flexibility and resistance foot exercise

No Intervention: Control Group
the group received usual care



Primary Outcome Measures :
  1. The number of plantar foot diabetic ulcer recurrence incidence [ Time Frame: up to 12 weeks ]
    The number of plantar foot diabetic ulcer recurrence incidence after healing of the last plantar foot diabetic ulcer at least 1 month. The measurement of diabetic foot ulcer by the specialist doctor using Wagner diabetic ulcer classification

  2. The number of plantar foot diabetic ulcer recurrence incidence [ Time Frame: up to 24 weeks ]
    The number of plantar foot diabetic ulcer recurrence incidence after healing of the last plantar foot diabetic ulcer at least 1 month. The measurement of diabetic foot ulcer by the specialist doctor using Wagner diabetic ulcer classification

  3. The time of plantar foot diabetic ulcer recurrence incidence [ Time Frame: up to 24 weeks ]
    The time of plantar foot diabetic ulcer recurrence incidence is found after healing of the last plantar foot diabetic ulcer at least 1 month.


Secondary Outcome Measures :
  1. change of ankle brachial index (ABI) [ Time Frame: from the date of assignment until the date of plantar foot diabetic ulcer recurrence found, whichever comes first, assessed up to 12 weeks and 24 weeks ]
    ABI is the ratio of the systolic blood pressure measured at the ankle to that measured at the brachial artery using hand held dopler with an 8 Megahertz (MHz) doppler probe

  2. change of HbA1c level [ Time Frame: from the date of assignment until the date of plantar foot diabetic ulcer recurrence found, whichever comes first, assessed up to 12 weeks and 24 weeks ]
    HbA1c is Glycated haemoglobin that measured in the laboratory with national glycohemoglobin standardization program (NGSP)

  3. change of diabetic neuropathy examination (DNE) score [ Time Frame: from the date of assignment until the date of plantar foot diabetic ulcer recurrence found, whichever comes first, assessed up to 12 weeks and 24 weeks ]
    The accumulation score of the result measurement consists of eight item, two testing muscle strength, one a tendon reflex, and five sensation. The min-max score is 0-16. The score was determined by doing a physical examination.

  4. change of walking speed [ Time Frame: from the date of assignment until the date of plantar foot diabetic ulcer recurrence found, whichever comes first, assessed up to 12 weeks and 24 weeks ]
    Walking speed is the ratio between times measured while walking in second as fast as possible on a flat and flat trajectory at a certain distance. A track distance used in the study was 5 meter. The time of waking was measured using stopwatch

  5. callus [ Time Frame: from the date of assignment until the date of plantar foot diabetic ulcer recurrence found, whichever comes first, assessed up to 12 weeks and 24 weeks ]
    Callus is the thickness of the plantar skin area that can be determined by inspection



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • signed an informed consent
  • aged 40-60 years
  • can walk within 5 meters
  • recently healed plantar foot diabetic ulcer (1-12 months)

Exclusion Criteria:

  • post amputation of right and left lower limb
  • contracture of lower limb
  • parkinson's
  • osteomyelitis history
  • paralysis

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): NCT04624516


Locations
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Indonesia
St Elisabeth School Health Science (STIKES St. Elisabeth Semarang)
Semarang, Central Java, Indonesia, 50252
Sponsors and Collaborators
Maria Suryani
Investigators
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Study Chair: Maria Suryani St. Elisabeth School Health Science (STIKES St Elisabeth Semarang)
Publications of Results:

Other Publications:

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Responsible Party: Maria Suryani, PhD (candidate), St Elisabeth School Health Science
ClinicalTrials.gov Identifier: NCT04624516    
Other Study ID Numbers: 4477112020
First Posted: November 10, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: the result of this study is available to cite another researchers
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: anytime
Access Criteria: mariahandoko22@gmail.com

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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 Maria Suryani, St Elisabeth School Health Science:
diabetic foot ulcer
diabetes melitus
ankle brachial index
diabetic neuropathy
exercise
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Recurrence
Pathologic Processes
Disease Attributes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases