NOT_YET_RECRUITING
VIRTUALLY SUPERVISED TELE-EXERCISE PLATFORM FOR ACCELERATING PLANTAR WOUND HEALING
The purpose of the study is design and use a telemedicine platform which integrates video-chat, pre-programmed interactive game-based foot, and ankle exercise modules, and real-time quantitative performance metrics displayed to the clinician to improve patient's perfusion to the lower extremity, improve diabetic wound healing and prevent muscle loss in the lower extremity.This is a cross sectional and comparative feasibility study. It is designed to explore acceptability, feasibility and proof of concept/ .
Conditions:
🦠 Diabetic Foot Ulcer
🗓️ Study Start (Actual) 3 September 2024
🗓️ Primary Completion (Estimated) 3 January 2028
✅ Study Completion (Estimated) 3 January 2028
👥 Enrollment (Estimated) 15
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Houston, Texas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Male or Female - 18 years or older - Diabetic Foot Ulcer - Ambulatory in the home without the aid of another person - Able to provide written informed consent

    Exclusion Criteria:

    • * Wound present for more than one year -HbA1c \> 12% -ABI of index limb is \<0.60 and/or they are being considered for revascularization within the course of the study -Ulcer involving bone or tendon -Ulcer not caused by diabetes -Fully confined to a wheelchair -Any condition limiting the ability to engage in Tele-FootX exercise routine such as major cognitive decline, and major visual or hearing problem -Unable or unwilling to attend prescribed clinic visits
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 28 May 2024
  • First Submitted that Met QC Criteria 28 May 2024
  • First Posted 3 June 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 May 2024
  • Last Update Posted 3 June 2024
  • Last Verified May 2024