Clinical trial NCT04624516: Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence
Official title: Effect of Self-structured Foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence Post Healing at Least One Month
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Diabetic Foot
Keywords: diabetic foot ulcer
diabetes melitus
ankle brachial index
diabetic neuropathy
exercise
Lead sponsor: St Elisabeth School Health Science
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: The number of plantar foot diabetic ulcer recurrence incidence
timeFrame: up to 12 weeks
measure: The number of plantar foot diabetic ulcer recurrence incidence
timeFrame: up to 24 weeks
measure: The time of plantar foot diabetic ulcer recurrence incidence
timeFrame: up to 24 weeks
Secondary outcomes:
measure: change of ankle brachial index (ABI)
timeFrame: 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
measure: change of HbA1c level
timeFrame: 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
measure: change of diabetic neuropathy examination (DNE) score
timeFrame: 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
measure: change of walking speed
timeFrame: 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
measure: callus
timeFrame: 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
Other outcomes:
Locations:
city: Semarang
country: Indonesia
facility: St Elisabeth School Health Science (STIKES St. Elisabeth Semarang)
state: Central Java
Study officials:
affiliation: St. Elisabeth School Health Science (STIKES St Elisabeth Semarang)
name: Maria Suryani
role: STUDY_CHAIR
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