Nonvisual Foot Examination for People With Diabetes and Visual Impairment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Because people who have both diabetes and visual impairment have high risk for foot problems, prevention of ulcers and amputation is a high priority. Usual care in diabetes self-management education (DSME) is to teach them to seek sighted assistance for regular foot examination, yet clinical experience suggests that this advice is seldom heeded. One possible solution is to teach use of the nonvisual senses of touch and smell for a systematic, thorough foot self-examination. The purpose of this pilot study was to compare the efficacy, acceptability, and feasibility of nonvisual foot examination with usual care (examination of the visually impaired person's feet by a sighted family member or friend).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nonvisual Foot Inspection for People With Visual Impairment

NCT01822717

Diabetes Visual Impairment

COMPLETED NA

Smart Diabetic Foot Care Application

NCT06844955

Diabetic Foot

ACTIVE_NOT_RECRUITING

Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy

NCT00223782

Diabetes Peripheral Neuropathy

COMPLETED NA

Sensorimotor Training and Gait in Diabetic Polyneuropathy

NCT04543032

Diabetic Peripheral Neuropathy

COMPLETED NA

Exercise-facilitated Neurorehabilitation in Diabetic Neuropathy

NCT00955201

Diabetic Neuropathy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Visual Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

DSME with Nonvisual Foot Examination

Group Type EXPERIMENTAL

DSME with Nonvisual Foot Examination

Intervention Type BEHAVIORAL

Diabetes Self-Management Education (DSME) with Nonvisual Foot Examination included comprehensive DSME taught by Certified Diabetes Educators that included instruction in nonvisual self-examination of feet using the senses of touch and smell.

Comparison

DSME with Usual Foot Examination Instruction

Group Type ACTIVE_COMPARATOR

DSME with Usual Foot Examination Instruction

Intervention Type BEHAVIORAL

DSME with usual foot examination instruction was comprehensive diabetes self management education taught by Certified Diabetes Educators that included usual care instructions for examination for feet at home by visually impaired persons, i.e., to have a sighted person check the feet regularly.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DSME with Nonvisual Foot Examination

Diabetes Self-Management Education (DSME) with Nonvisual Foot Examination included comprehensive DSME taught by Certified Diabetes Educators that included instruction in nonvisual self-examination of feet using the senses of touch and smell.

Intervention Type BEHAVIORAL

DSME with Usual Foot Examination Instruction

DSME with usual foot examination instruction was comprehensive diabetes self management education taught by Certified Diabetes Educators that included usual care instructions for examination for feet at home by visually impaired persons, i.e., to have a sighted person check the feet regularly.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* over age 18
* diagnosed with either type 1 or type 2 diabetes
* stated they had visual impairment

Exclusion Criteria

* unable to pass a brief decisional capacity test
* had a score above 80 on the near vision scale of the National Eye Institute Visual Functioning Questionnaire
* had bilateral lower extremity amputations
* by self-report were unable to sense light touch on two or more fingers or either hand

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No