Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00286598 · ClinicalTrials.gov registry record · Phase 1

Feet First: Promoting Physical Activity Among People With Diabetes Mellitus and Insensate Feet

A Phase 1 study, sponsored by University of Missouri-Columbia.

Completed
Registry status
Phase 1
Development phase
79
Enrollment target

NCT00286598 is a Phase 1 study that has completed, run by University of Missouri-Columbia. The registered enrollment target is 79 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00286598, a Phase 1 study, has completed, sponsored by University of Missouri-Columbia.

COMPLETED
Registry status
Phase 1
Development phase
79 participants
Enrollment target

Study Summary

The role of weight-bearing physical activity in the development of diabetic foot ulcers remains poorly understood. Regular participation in moderately intense physical activity (e.g. brisk walking ) reduces 8-year cardiovascular mortality in those with diabetes mellitus by over 30%. The American Diabetes Association (ADA) recommends at least 30 minutes of daily moderate intensity activity for people with diabetes. However, the ADA recommends that people with diabetes and insensate feet, which affects up to 40% of those with diabetes, should limit their walking because of concerns that walking could increase the risk of foot ulcers and amputation. Firm evidence is lacking to support these concerns; in fact, while a research fellow I conducted an observational study that showed daily weight-bearing activity may reduce the risk of foot ulceration among people with diabetic foot problems. A controlled clinical trial is needed to study these issues further. The present study is a randomized controlled trial in 100 older adults with diabetes and insensate feet, 50 of whom will participate in an individually-tailored behavior-change intervention called "Feet First", and 50 of whom will be controls. The intervention is based on the extensively-tested CHAMPS model used by the Robert Wood Johnson Foundation's Active for Life Program. Feet First extends the target population beyond older adults generally to people with insensate feet due to diabetic peripheral neuropathy. The specific aims of the study are: * To determine whether Feet First intervention subjects achieve a greater increase in weight-bearing activity than control subjects, and * To obtain preliminary evidence on intervention subjects' foot outcomes (foot function, foot-related self-care, and risk of foot ulcers), compared to control subjects.

Interventions

  • BEHAVIORAL Feet First

Trial Details

FieldValue
Enrollment Target 79 participants
Start Date 2005-01
Est. Completion 2008-06
Phase Phase 1

Sponsor

University of Missouri-Columbia

291 total trials

What the Registry Record Tells You About NCT00286598

The ClinicalTrials.gov registry entry for NCT00286598 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Feet First is the first listed.

NCT00286598 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00286598 about?

NCT00286598 is a clinical study titled "Feet First: Promoting Physical Activity Among People With Diabetes Mellitus and Insensate Feet". The role of weight-bearing physical activity in the development of diabetic foot ulcers remains poorly understood. Regular participation in moderately intense physical activity (e.g. brisk walking ) reduces 8-year cardiovascular mortality in those with diabetes mellitus by over 30%. The American Dia...

What is the current status of trial NCT00286598?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 79 participants. The study started on 2005-01. Estimated completion is 2008-06.

What interventions are being tested in trial NCT00286598?

The interventions under investigation include: Feet First (BEHAVIORAL).

Who is sponsoring clinical trial NCT00286598?

This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.