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

NCT06434922 | Completed

• 1 other identifier: ID01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrence; Diabetic Foot; Thermography; Quality of Life

Outcome Measures

Primary Outcomes (2)

• The degree of risk of recurrence

  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.

  up to three months

• Efficacy of prevention strategies

  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

  up to three months

Secondary Outcomes (2)

• Quality of life of DFU's

  up to three months

• Health status of DFU's

  up to three months

Study Arms (2)

Prevention Strategies

EXPERIMENTAL

Groups received the prevention strategies to prevent the recurrence of DFU's

Device: Prevention Strategies

Standard Strategies

OTHER

Groups received the standard strategies to prevent the recurrence of DFU's

Device: Standard Strategiies

Interventions

Prevention Strategies DEVICE

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.

Prevention Strategies

Standard Strategiies DEVICE

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

Standard Strategies

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Declined to participate

Sponsors & Collaborators

• Institute Technology and Health Muhammadiyah West Kalimantan: lead

Study Sites (1)

Haryanto Haryanto

Pontianak, West Kalimantan, 78164, Indonesia

Location

Related Publications (1)

• Haryanto H, Sari Y, Panjaitan E, Juminar J, Armstrong D. A Randomized Clinical Trial Study on the Prevention Strategy and Early Detection of Ulcer Recurrence in Patients with Type 2 Diabetes Mellitus Using the Risk of Recurrence Ulcer Tool. Int J Low Extrem Wounds. 2025 Sep;24(3):655-663. doi: 10.1177/15347346241283160. Epub 2024 Oct 21.

  PMID: 39434549 DERIVED

MeSH Terms

Conditions

Recurrence; Diabetic Foot

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Haryanto Haryanto

  ITEKES Muhammadiyah Kalimantan Barat

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The investigators known the groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Intervention group: 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. 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. Control group: Patients were educated about DM management, medication adherence, dietary practices, physical exercise routines, and foot care through pamphlets.

Study Record Dates

• First Submitted: May 18, 2024
• First Posted: May 30, 2024
• Study Start: January 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: May 31, 2024

Record last verified: 2024-05

Locations

ID (1)