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Clinical Trials/NCT06434922
NCT06434922CompletedNot Applicable

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

Institute Technology and Health Muhammadiyah West Kalimantan2 sites in 1 country60 target enrollmentStarted: January 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
2
Primary Endpoint
Efficacy of prevention strategies

Study Overview

Brief 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.

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 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Masking Description

The investigators known the groups.

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants have a history of diabetic foot ulcers.
  • signed an informed consent

Exclusion Criteria

  • Declined to participate

Outcomes

Primary Outcomes

Efficacy of prevention strategies

Time Frame: up to three months

Prevention stratagies is evaluated using INDIFURUTO tool (history of amputation, smoking, serum glucose levels, ankle-brachial index, monofilament test results, and differences in foot skin temperature). Good=INDIFURUTO total score increase than baseline and Poor=INDIFURUTO total score decrease than baseline

The degree of risk of recurrence

Time Frame: up to three months

The risk level recurrence ulcer tool, INDIFURUTO (Indonesian Diabetic Foot Ulcer Recurrence Assessment Tool), was used to assess the risk level. 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.

Secondary Outcomes

  • Quality of life of DFU's(up to three months)
  • Health status of DFU's(up to three months)

Investigators

Sponsor
Institute Technology and Health Muhammadiyah West Kalimantan
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Haryanto Haryanto

Principal Investigator

Institute Technology and Health Muhammadiyah West Kalimantan

Study Sites (2)

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