Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02632695

Physical Activity Interventions for Leg Ulcer Patients — FOOTFIT  

Venous Ulcers Clinical Trial

Official title:
Physical Activity Interventions for Leg Ulcer Patients

Clinical Trial 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.

Clinical Trial Description

FOOTFIT is a study of a lower leg conditioning mHealth intervention for patients with venous leg ulcers. The aims are to compare two versions, one of which is enhanced (FOOTFIT+), to determine which has the greatest impact on physical activity adherence, patient-provider communication, and leg function. FOOTFIT and FOOTFIT+ share three components: 1) a low-cost, tri-axial Bluetooth® enabled highly sensitive accelerometer and tracking device (BEAT) worn on the foot during, 2) phased conditioning activities for lower leg function (CALF) tracked by a, 3) Smartphone that captures signals from BEAT, provides motivational messages, CALF instruction, and automated feedback on progress. Forty patients will be targeted in this six-week study, 20 of which will receive FOOTFIT and 20 FOOTFIT+. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02632695
Study type Interventional
Source Medical University of South Carolina
Contact
Status Completed
Phase N/A
Start date April 2015
Completion date August 31, 2018
View Details
See also
  Status Clinical Trial Phase
Completed NCT00207818 - Treatment of Cutaneous Ulcers With a Novel Biological Dressing Phase 1/Phase 2
Terminated NCT00545298 - Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers Phase 2
Completed NCT03070925 - Prospective PuraPly™ AM Case Series Study N/A
Not yet recruiting NCT01491438 - Plasma Rich Growth Factors in Venous Ulcers N/A
Completed NCT01348581 - Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing N/A
Completed NCT02034396 - Clinical Implications of Genetic Variations of Venous Stasis Ulceration N/A
Completed NCT06280053 - HealiAid in the Treatment of Different Wounds N/A
Completed NCT02364921 - Effectiveness of Double-layer Compression Therapy in the Healing of Chronic Venous Ulcers in Primary Health Care N/A
Suspended NCT02930499 - Effect of Hyaluronic Acid ECM on Venous Ulcers N/A
Recruiting NCT06350695 - The ROle of Compression StocKings in Heart Failure Patients N/A
Completed NCT01214980 - Split Thickness Donor Site Healing With MIST Study N/A
Terminated NCT00613808 - Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers Phase 2
Completed NCT04703569 - Effect of Compressive Therapies on the Healing of Venous Ulcers N/A
Completed NCT01509599 - Cooling Lower Leg Skin to Prevent Venous Leg Ulcers in Patients With Poor Vein Circulation Phase 1/Phase 2
Terminated NCT02071979 - Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds N/A