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

November 9, 2020 updated by: Maria Suryani

Effect of Self-structured Foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence Post Healing at Least One Month

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Introduction

    Diabetic foot ulcers are a form of diabetes mellitus (DM) patients' foot problems, characterized by chronic wounds below the ankle, which can penetrate the skin to the dermis. Meta-analysis results in 2016 showed a global prevalence of diabetic foot ulcers of 6.3%. The incidence in Indonesia reaches 7.3 - 24%.

    Diabetic foot ulcers can result in amputation and even death in patients. The diabetic foot ulcer caused 85% of foot amputation cases and 2.48 times higher than for patients without ulcers in the next five years. Diabetic foot ulcers can provide a high economic burden for patients, families, and the country due to the healing period of diabetic foot ulcers and expensive maintenance costs.

    Healed diabetic foot ulcers can undergo recurrence. Approximately 26 -78% of all diabetic foot ulcer incidents are recurrence events. Prevalence of recurrence globally within one year, three years, and five years after diabetic foot ulcer healing is 40%, 60 %, and 65%. The prevalence of diabetic foot ulcer recurrence in Semarang, Indonesia country reaches 35.4 %. It indicates that post-cured diabetic foot ulcer patients have a very high risk for recurrence of diabetic foot ulcers.

    The high incidence of diabetic foot ulcer recurrence is closely related to the biological and behavioral factors of patients who have not been resolved, despite the healing. The previous studies explained that the risk factors for diabetic foot ulcer recurrence after recovery include the location of plantar ulcers, HbA1c > 7,5%, peripheral artery disease, peripheral neuropathy, the absence of callus, duration of ulcers, duration of DM, and limitations of foot musculoskeletal function.

    The International Working Group on Diabetic Foot (IWGDF) stress the importance of efforts to prevent the occurrence of diabetic foot ulcers.The act of performing foot exercises has not been a guideline in preventing diabetic foot ulcer recurrence, although exercise is highly recommended in all DM patients to prevent diabetic foot ulcers. The recent studies, limited to DM patients, showed that foot exercises designed for DM patients could increase joint range of motion, muscle strength, walking speed, ankle-brachial index (ABI) as well as lower HbA1c levels that are also risk factors for diabetic leg ulcer recursion. Self-structured foot exercises are a combination of foot resistance exercises using flexible bands and foot flexibility exercises performed independently by patients, with frequencies three times a week at home. The study aimed to prove the effect of self-structured foot exercise on plantar foot diabetic ulcer recurrence incidence after recovery of at least one month.

  2. Methods

The study used a Randomised control trial (RCT) design. The study had approved by the ethics committee of the Faculty of Medicine, Diponegoro University. The participants of the study were patients with healed plantar foot diabetic ulcers who had been treated at two hospitals in Semarang Indonesia and had been selected consecutively. The study carried out random allocation using software into a control group and intervention group. The participants were directly supervised in the first three weeks and after that supervised using a mobile phone.

The demographics and characteristics related to diabetic foot ulcer history were collected. The changing of ABI, diabetic neuropathy examination score, HbA1c level, walking speed, and callus before and after intervention were collected also. The researchers took all of the data outcomes before the intervention, 12 and 24 weeks after foot exercises. The participants discontinued the intervention if they had recurrence before 24 weeks, and then data retrieval was carried out one last time. The time of recurrence incidence was recorded.

The analysis of data used a computer with SPSS. The researchers used the Shapiro Wilk normality test to see the distribution of numerical data. Homogeneity of respondents' characteristics and the changes difference in DNE, ABI, walking speed, and HbA1c levels were tested using independent T-tests, Man Whitney, Chi-Square, and Fisher tests. Changing in DNE, ABI, HbA1c levels, and walking speed were calculated by calculating the difference in the last data collection results with the preliminary data collection from respondents. The difference of calluses between two group after the intervention were tested also. Spearman's test was conducted to look at the effect of ABI improvements, DNE scores, HbA1c levels, and walking pace on the decrease in plantar foot diabetic ulcer recurrence. Recurrence data for participants who did not complete the outcome for 24 weeks were filled in according to the last condition found. Chi-square tests and relative risk (RR) calculations with 2x2 tables, Confidence Interval (CI) 95%, and significant levels of <5% were conducted to determine the effect of self-structured foot exercises on plantar foot diabetic ulcer recurrence incidence. A logistical regression multivariate test was conducted to look at the effect of self-structured foot exercises, on plantar foot diabetic ulcer recurrence with control on confounding variables. Cox's multivariate regression test was conducted to look at the effect of self-structured foot exercises on the timing of plantar foot diabetic ulcer recurrence events with control on confounding variables.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Central Java
      • Semarang, Central Java, Indonesia, 50252
        • St Elisabeth School Health Science (STIKES St. Elisabeth Semarang)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 12 weeks
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
up to 24 weeks
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.
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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)
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
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.
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Suryani

Investigators

  • Study Chair: Maria Suryani, St. Elisabeth School Health Science (STIKES St Elisabeth Semarang)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 4, 2019

Primary Completion (ACTUAL)

July 30, 2020

Study Completion (ACTUAL)

July 30, 2020

Study Registration Dates

First Submitted

November 4, 2020

First Submitted That Met QC Criteria

November 9, 2020

First Posted (ACTUAL)

November 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4477112020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the result of this study is available to cite another researchers

IPD Sharing Time Frame

anytime

IPD Sharing Access Criteria

mariahandoko22@gmail.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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