Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434922
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2024-05-18
Brief Title:
Prevention and Early Detection of Ulcer Recurrence in Patients With Type II Diabetes Mellitus
Sponsor:
Institute Technology and Health Muhammadiyah West Kalimantan
Organization:
Institute Technology and Health Muhammadiyah West Kalimantan
Study Overview
Official Title:
A Randomized Clinical Trial Study on the Prevention Strategy and Early Detection of Ulcer Recurrence in Patients With Type II Diabetes Mellitus Using the Risk of Recurrence Ulcer Tool
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to to evaluate the effectiveness of prevention strategies of recurrence in DFUs 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 DFUs
How the risk level of the recurrence on DFUs patients
How the impact of quality of life on DFUs 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
Does intervention of prevention strategies effective to prevent the recurrence of DFUs
How the risk level of the recurrence on DFUs patients
How the impact of quality of life on DFUs 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
Detailed 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 1330 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 included1 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
11 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 21 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 005 power β of 095 proportion p1 of 012 in group 1 and proportion p2 of 054 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 studys 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
22 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 150 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 57 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 clawhammer 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 Cronbachs alpha coefficient of 079 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
23 Data Analysis All data were analyzed using SPSS software version 260 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 005 was chosen as the level of significance
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 1330 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 included1 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
11 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 21 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 005 power β of 095 proportion p1 of 012 in group 1 and proportion p2 of 054 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 studys 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
22 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 150 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 57 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 clawhammer 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 Cronbachs alpha coefficient of 079 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
23 Data Analysis All data were analyzed using SPSS software version 260 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 005 was chosen as the level of significance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None