The Effect of Thermal Evaluation in Prevention of Diabetic Foot Ulcer

NCT04480801 | Completed DMC

• 1 other identifier: FOzkal
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The study was planned as a prospective randomized controlled clinical trial to determine the effect of thermal evaluation in preventing diabetic foot ulcers in patients with Type II Diabetes Mellitus (DM).

Conditions

Diabetic Foot

Keywords

Diabetes Mellitus; diabetic foot; risk factors; thermal evaluation

Outcome Measures

Primary Outcomes (1)

• Percentage of patients developing a foot ulcer

  There will be a correlation between diabetic foot development and high temperature values obtained from thermal evaluation.

  2 months after the first assessment

Secondary Outcomes (2)

• Changes in blood sugar values

  2-month intervals until 1-year follow-up

• Change in foot care practices

  2-month intervals until 1-year follow-up

Study Arms (2)

thermal evaluation and foot care

EXPERIMENTAL

Participants in the experimental group will be given foot care in the clinic and will be taught to the patient and / or their relatives. The foot care video will be uploaded to the patient and / or relative's phone. Thermal evaluation will be done. The application of the thermal evaluation, the foot areas to be applied and how to record the results of the application will be taught to the patient and / or their relatives. In addition, the thermal evaluation video will be uploaded to the phone of the patient and / or their relative. While the participants in the experimental group were discharged; Blood glucose monitoring chart, Checklist to record foot care interventions, Thermal evaluation registration form, Daily step number registration form will be provided and participants will be invited to check every 2 months.

Other: Thermal Evaluation and Foot Care

foot care

OTHER

Participants in the control group will be given foot care in the clinic and will be taught to the patient and / or their relatives. The foot care video will be uploaded to the patient and / or relative's phone.While the participants in the control group were discharged; Blood glucose monitoring chart, Checklist to record foot care interventions will be provided and participants will be invited to check every 2 months.

Other: Foot Care

Interventions

Thermal Evaluation and Foot Care OTHER

Participants in the experimental group will be given foot care and thermal evaluation in the clinic and will be taught to the patient and / or their relatives. Thermal evaluation and foot care video will be uploaded to the patient and / or relative's phone.

thermal evaluation and foot care

Foot Care OTHER

Participants in the control group will be given foot care in the clinic and will be taught to the patient and / or their relatives. Foot care video will be uploaded to the patient and / or relative's phone.

foot care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and over
• Volunteer
• Sign the informed consent form
• Diagnosed with type II Diabetes Mellitus
• No diabetic foot ulcer
• Patients with no foot or toe amputation will be admitted.

You may not qualify if:

• Does not sign the informed consent form
• Without a smart phone
• Diagnosed with Type I Diabetes Mellitus,
• Patients with diabetic foot ulcers
• With ankle / arm index \<0.9 and \>1.30,

Sponsors & Collaborators

• Fatma Özkal: lead
• Necmettin Erbakan University: collaborator

Study Sites (1)

Necmettin Erbakan University

Konya, 42080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• FATMA ÖZKAL

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

• Serpil YÜKSEL, Phd

  Necmettin Erbakan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: prospective randomized controlled clinical trial

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 21, 2020
• Study Start: September 15, 2020
• Primary Completion: June 15, 2022
• Study Completion: June 1, 2023
• Last Updated: August 30, 2023

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)