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Prevention and Early Detection of Ulcer Recurrence in Patients With Type II Diabetes Mellitus

NCT06434922 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-05-31

No results posted yet for this study

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.

Conditions

  • Recurrence
  • Diabetic Foot
  • Thermography
  • Quality of Life

Interventions

DEVICE

Prevention Strategies

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.

DEVICE

Standard Strategiies

Group were educated about DM management, medication adherence, dietary practices, physical exercise routines, and foot care through pamphlets

Sponsors & Collaborators

  • Institute Technology and Health Muhammadiyah West Kalimantan

    lead OTHER

Principal Investigators

  • Haryanto Haryanto · ITEKES Muhammadiyah Kalimantan Barat

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06434922 on ClinicalTrials.gov