Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence
Condition: Diabetic Foot Ulcer; Diabetic Foot
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer; Recurrence
Study type: Interventional

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.
    

Intervention name(s): self-structured foot exercise
Intervention type(s): Other
Intervention description(s): 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 intervention name(s): foot exercise; flexibility and resistance foot exercise
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)
Primary purpose: Prevention
Keywords: diabetic foot ulcer; diabetes melitus; ankle brachial index; diabetic neuropathy; exercise