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

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04624516
• Other study ID #: 4477112020
• Status: Completed
• Phase: N/A
• Start date: September 4, 2019
• Est. completion date: July 30, 2020

Study information

• Verified date: November 2020
• Source: St Elisabeth School Health Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Recurrence
• Ulcer

Intervention

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)

Locations

Country	Name	City	State
Indonesia	St Elisabeth School Health Science (STIKES St. Elisabeth Semarang)	Semarang	Central Java

Sponsors (1)

Lead Sponsor	Collaborator
Maria Suryani

Country where clinical trial is conducted

Indonesia, 

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of plantar foot diabetic ulcer recurrence incidence	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
Primary	The number of plantar foot diabetic ulcer recurrence incidence	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
Primary	The time of plantar foot diabetic ulcer recurrence incidence	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	change of ankle brachial index (ABI)	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
Secondary	change of HbA1c level	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
Secondary	change of diabetic neuropathy examination (DNE) score	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
Secondary	change of walking speed	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
Secondary	callus	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