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

NCT00286598 is a Phase 1 study that has completed, run by University of Missouri-Columbia. The registered enrollment target is 79 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.

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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
University of Missouri-Columbia

291 total trials

What the finished NCT00286598 record still lists

NCT00286598 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% higher).

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

NCT00286598 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00286598's enrollment target sits among peer trials

79 696th of 2000 higher than 1,304 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00286598, the US trial registry maintained by the National Library of Medicine. NCT00286598 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.