MedTrace Logo

Implementation of Foot Thermometry and SMS and Voice Messaging to Prevent Diabetic Foot Ulcer

NCT02373592 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2017-12-15

No results posted yet for this study

Summary

This study aims to implement daily temperature measurements of feet complemented by SMS and voice messaging to prevent diabetic foot ulcers in patients with type 2 diabetes mellitus at high risk of ulceration.

Design: Physician-blinded, randomized, 18-month trial.

Setting: Diabetes outpatient clinics from two public hospitals

Population: Subjects will be eligible if they (1) have a diagnosis of type 2 diabetes mellitus, (2) are between 18 - 80 years of age, (3) have a present dorsalis pedis pulse in both feet, (4) are in risk group 2 or 3 using the diabetic foot risk classification system as specified by the International Working Group on the Diabetic Foot, (5) have an operating cell phone or a caregiver with an operating cell phone, and (6) have the ability to provide informed consent.

Hypothesis: The investigators hypothesize that implementation of an enhanced intervention that combines daily temperature measurement for the reduction of diabetic foot ulcer with SMS and voice messaging will improve patient measurement compliance and reduce diabetic foot ulcers in a middle income country.

Conditions

  • Diabetic Foot

Interventions

BEHAVIORAL

SMS and voice messaging

This group will receive reminders to use the TempStat (two messages) and promote foot care (six messages). The content of these eight messages have been developed and validated their delivery through both, SMS and voice messaging. During the first two weeks of the intervention, only reminders to use the TempStat will be sent, daily, Monday to Friday, both via SMS and voice messaging. Hereafter, for the remaining 76 weeks, patients will only receive two messages per week, one SMS and one voice message, alternating content (reminders to use TempStat and promotion of foot care).

DEVICE

Thermometry

Subjects will be provided with a TempStat (foot thermometer), a device that captures a thermal image of feet. (See Detailed description)

Sponsors & Collaborators

  • Johns Hopkins University

    collaborator OTHER

  • Mayo Clinic

    collaborator OTHER

  • University of Southern California

    collaborator OTHER

  • Universidad Peruana Cayetano Heredia

    lead OTHER

Principal Investigators

  • Jaime Miranda, MD, PhD · Universidad Peruana Cayetano Heredia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-09-30
Completion
2017-10-31

Countries

  • Peru

Study Locations

More Related Trials

Entities

Companies

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 NCT02373592 on ClinicalTrials.gov