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NCT02632695 · ClinicalTrials.gov registry record · NA
Physical Activity Interventions for Leg Ulcer Patients
A NA study of Leg Ulcers and Venous Ulcers, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT02632695: Completed NA study of Leg Ulcers and Venous Ulcers, sponsored by Medical University of South Carolina.
NCT02632695 is a NA study of Leg Ulcers and Venous Ulcers that has completed, run by Medical University of South Carolina. The registered enrollment target is 24 participants, below the 47-participant average among 3 other Leg Ulcers trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02632695, a NA study of Leg Ulcers and Venous Ulcers, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to test FOOTFIT and enhanced FOOTFIT+, home-based mobile health (mHealth) physical activity (PA) interventions for a minimally ambulatory, chronically-ill, population with leg ulcers. A highly sensitive clinically designed Bluetooth® enabled accelerometer and tracking device (BEAT) worn on the foot during a progressive and evidence-based non-exertive leg conditioning activities for lower leg function (CALF) captures minute foot movements and sends the data to a Smartphone. This six-week feasibility study will compare FOOTFIT to FOOTFIT+, with the added connectivity feature, to promote patient-provider communication, evaluate adherence to PA, and assess signals of efficacy on functional outcomes in a very low fitness population.
Primary Outcome
Measure adherence by recording frequency and intensity of foot/toe movements reported in minutes.
Conditions Studied
Interventions
- DEVICE FOOTFIT
Study Locations (1)
South Carolina
- Spartanburg Regional Medical Center - Spartanburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-04 |
| Est. Completion | 2018-08-31 |
| Phase | NA |
What the finished NCT02632695 record still lists
NCT02632695 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 47-participant average among 3 other Leg Ulcers trials with a reported enrollment target (49% lower).
The record links to 3 conditions, with Leg Ulcers appearing as the primary indexed condition, and to 1 intervention - of which FOOTFIT is the first listed.
NCT02632695 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT02632695 about?
NCT02632695 is a clinical study titled "Physical Activity Interventions for Leg Ulcer Patients". The goal of this study is to test FOOTFIT and enhanced FOOTFIT+, home-based mobile health (mHealth) physical activity (PA) interventions for a minimally ambulatory, chronically-ill, population with leg ulcers. A highly sensitive clinically designed Bluetooth® enabled accelerometer and tracking devic...
What is the current status of trial NCT02632695?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2015-04. Estimated completion is 2018-08-31.
What conditions does trial NCT02632695 study?
This clinical trial studies the following conditions: Leg Ulcers, Venous Ulcers, Varicose Ulcers.
What interventions are being tested in trial NCT02632695?
The interventions under investigation include: FOOTFIT (DEVICE).
Who is sponsoring clinical trial NCT02632695?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02632695 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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