Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06434922 |
| Other study ID # |
ID01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2023 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
May 2024 |
| Source |
Institute Technology and Health Muhammadiyah West Kalimantan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is to to evaluate the effectiveness of prevention strategies
of recurrence in DFU's. It will also to detect the risk level of recurrence. The main
question it aims to answer are:
- Does intervention of prevention strategies effective to prevent the recurrence of DFU's?
- How the risk level of the recurrence on DFU's patients?
- How the impact of quality of life on DFU's patients?
Researchers will compare intervention groups (receiving education covered various aspects,
including they received guidance on foot examination, foot care, dietary habits, physical
exercise, and stress management), and control groups (received standards follow-up care
provided by healthcare providers, including pamphlets outlining care for DM patients based on
the five pillars, including DM management, medication adherence, dietary practices, physical
exercise routines, and foot care).
Participants will:
- For intervention group will be educated every month
- Data for both intervention and control groups were collected monthly until three months.
Description:
1. Introduction
A recurrence of a diabetic foot ulcer refers to the emergence of a new foot ulcer in
individuals with a prior history of foot ulceration, irrespective of the specific
location or duration since the occurrence of the previous ulcer. Even after the
resolution of a foot ulcer, recurrence remains a common problem. In Indonesia, studies
have indicated a recurrence rate of diabetic foot ulcers ranging from 13.30% to 35%,
while global recurrence rates vary significantly among different countries. Thus,
implementing prevention strategies is crucial in averting recurrence. These strategies,
such as proper foot care, glycemic control, and early detection and management of risk
factors, can significantly reduce the occurrence and recurrence of diabetic foot ulcers.
Several studies have highlighted various preventive treatments aimed at decreasing the
likelihood of diabetic foot ulcer recurrence. These treatments include integrated foot
care, self-management techniques, patient education, therapeutic footwear utilization,
and surgical intervention. Recent research has also explored the potential of
thermography in detecting foot ulcer risk among patients with diabetes mellitus. While
numerous original studies and systematic reviews have reported prevention strategies for
preventing diabetic foot recurrence, there is limited research on the combined approach
of early detection and prevention of foot ulcer recurrence.
In Indonesia, preventive strategies for diabetes mellitus patients have been implemented
through the PROLANIS program, a chronic disease management initiative launched in 2010
in community health centers. PROLANIS focuses on diabetes self-management and follows
the five-pillar method established by the Indonesian Society of Endocrinology (PERKENI),
encompassing dietary practices, physical activity, pharmaceutical interventions, glucose
monitoring, and educational initiatives. Despite the nationwide adoption of these
pillars since 2011, the prevalence of recurrence remains significant in Indonesia.
Prevention strategies, carried out by healthcare provider teams, including nursing
staff, are vital in addressing this challenge. Nurses are involved in physical
assessment, early detection, foot care, and education, making their role crucial in
implementing prevention strategies.
Early detection is integral to preventing ulcer recurrence. A systematic review
identified three main types of interventions used in early ulcer recurrence detection:
conventional physical assessment, 3D thermal camera assessment systems, and diabetic
foot screening instruments. Hence, further development of early detection methods for
recurrence risk is necessary.
The study utilized a multifaceted approach incorporating four techniques to reduce the
risk of ulcer recurrence in patients with DM. These strategies included:1) conducting a
thorough physical examination and assessing the foot, which involved utilizing a
thermograph to identify variations in skin temperature; 2) implementing appropriate foot
care practices; 3) providing patients with educational resources and guidance; and 4)
promptly identifying and addressing factors that may increase the likelihood of ulcer
recurrence.
1.1. Objective The primary objective of this study is to assess the efficacy of
preventive measures while ascertaining the degree of risk associated with potential
recurrences using the risk of recurrence ulcer tool. Additionally, an assessment was
conducted to evaluate the impact on the quality of life.
2. Methods and Materials 2.1. Study Design and Participants This study is prospective
clinical trial design to evaluate the effectiveness of prevention strategies utilizing
an early detection tool for ulcer recurrence. The study had approved by the ethics
committee of the Institute of Technology and Health Muhamamdiyah West Kalimantan.
Conducted between January and July 2023 at two community health centers in Pontianak and
Kubu Raya, West Kalimantan, Indonesia, the study followed the Consolidated Standards of
Reporting Trials (CONSORT); randomized controlled trial (RCT) guidelines principles.
Sixty participants were recruited using simple random allocation sampling, with 30
individuals assigned to each group based on calculated sample size requirements. G Power
software was utilized to determine sample size, considering a significance level (α) of
0.05, power (β) of 0.95, proportion (p1) of 0.12 in group 1, and proportion (p2) of 0.54
in group 2. Inclusion criteria included the ability to perform everyday tasks,
cooperation, and ulcer recovery for at least two weeks, while exclusion criteria
comprised serious illnesses or sequelae, active foot ulcers, Charcot
neuro-osteoarthropathy, persistent limb-threatening ischemia, and foot infections.
Participants who had received care at the community health centers and had recovered from
their wounds constituted the intervention and control groups. Recruitment involved searching
medical records and contacting eligible individuals. Written informed consent was obtained
before enrollment. The 60 participants were divided into intervention and control groups.
Both groups were encouraged to visit the community health centers, with researchers
conducting home visits if necessary. The intervention group received the study's treatment,
while the control group received standard follow-up care provided by healthcare providers,
including pamphlets outlining care for DM patients based on the five pillars, including ulcer
prevention.
2.2. Data Collection In this investigation, four research assistants underwent training
following the study protocol to conduct examinations on diabetic feet, which included
utilizing tools such as the thermograph, monofilament test, vascular Doppler ultrasound,
conventional foot plantar scan, and diabetic foot and nail care. Additionally, they were
trained in collecting demographic data, assessing diabetic wounds, and educating patients.
Patient education covered various aspects, including regular monitoring of blood glucose
levels, effective dietary management, consistent physical activity, routine foot inspections,
adherence to prescribed medications, and appropriate footwear selection based on plantar foot
pressure measurements. Following plantar foot pressure measurement, patients were educated on
maintaining regular blood sugar control, dietary management, exercise routines, foot
inspection practices, medication adherence, and proper footwear selection.
During the intervention procedure, data collection sessions lasted approximately 1 to 1.50
hours, with education and foot care provided once a month. Subsequently, patients underwent
monthly follow-ups for three months, during which they received guidance on foot examination,
foot care, dietary habits, physical exercise, and stress management.
For the control group, a comprehensive foot examination was conducted at the initial
assessment to evaluate the overall foot health of participants. Patients in the control group
were educated about DM management, medication adherence, dietary practices, physical exercise
routines, and foot care through pamphlets. Data for both intervention and control groups were
collected monthly through examinations and inspections, each conducted by two nurses who had
completed preventive foot care training.
Throughout the study, data collection included vascular Doppler ultrasonography (BT-200 V, 8
MHz; Bistos Co., Ltd., Seongna, Korea) for assessing the ankle-brachial index (ABI) and the
monofilament test using a 10-g (5.7) Semmes-Weinstein monofilament to evaluate neuropathic
status. Additionally, plantar pressure distribution data were collected using a foot printer
(Bauerfeind AG, Thuringia, Germany) and a callus removal device. Clinical examinations were
conducted to assess structural and functional foot deformities, including claw/hammer toe,
hallux rigidus, hallux valgus, bony prominences, pes cavus, pes planus, and metatarsal head
abnormalities.
The risk level recurrence ulcer tool, INDIFURUTO (Indonesian Diabetic Foot Ulcer Recurrence
Assessment Tool), was utilized to assess the risk level. INDIFURUTO considers factors such as
history of amputation, smoking, serum glucose levels, ankle-brachial index, monofilament test
results, and differences in foot skin temperature. Skin temperature measurements were
obtained using smartphone-based thermography (FLIR ONE Gen 3, Teledyne FLIR LLC, Wilsonville,
OR, USA). Subjects were categorized as high risk if they scored less than or equal to 22
points, medium risk if they scored between 23 and 45, and low risk if they scored more than
or equal to 46. Previous studies have demonstrated high sensitivity (100%) and specificity
(90%) of this tool. INDIFURUTO assessments were conducted at baseline, and at the second and
third follow-up assessments for both groups.
The European Quality of Life 5 Dimensions 3 Level (EQ-5D-3L) version was utilized to evaluate
participants' quality of life, a measure that has demonstrated reliability with a Cronbach's
alpha coefficient of 0.79. Quality of life assessments were conducted at baseline, as well as
at the second and third follow-up assessments for both intervention and control groups.
Participants self-assessed their level of mobility, self-care, usual activities, pain or
discomfort, and anxiety or depression, with responses ranging from level 1 (indicating the
best state) to level 3 (indicating the worst state). Additionally, participants reported
their current health status using a visual analog scale (EQ-VAS) that ranged from 0
(indicating the lowest health status) to 100 (indicating the highest health status) points.
Demographic data were also collected, including information on gender, age, BMI, duration of
diabetes mellitus (DM), fasting blood sugar value, ethnicity, occupation status, education
level, religion, smoking status, type of diabetes, diabetes treatment, presence of DM
complications, foot deformities, history of previous amputation, and time elapsed since the
last ulcer healed.
2.3. Data Analysis All data were analyzed using SPSS software (version 26.0; IBM Corp.,
Armonk, NY, USA). The demographic variables were assessed using descriptive statistics
(means, standard deviation, frequencies). A mixed model for repeated measures analysis was
used to test the differences in quality of life and high-risk level on baseline and the third
follow-ups between the two groups. p < 0.05 was chosen as the level of significance
