Enhanced Ultrasound Treatment of Chronic Wounds With Monitoring of Healing and Quality of Life Outcomes
NCT03041844 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2022-04-06
Summary
The purpose of this study is to evaluate the effect of low frequency, low intensity ultrasound treatment on wound healing and health-related quality of life with a randomized clinical trial of patients with venous ulcers or diabetic ulcers.
Conditions
- Diabetic Foot Ulcer
- Venous Ulcer
Interventions
- DEVICE
-
Low Frequency, Low Intensity Ultrasound
Therapeutic ultrasound (20 kHz, \<100 mW/cm2 spatial peak-temporal peak)
- DEVICE
-
Sham Applicator
Sham ultrasound applicator
Sponsors & Collaborators
- collaborator OTHER
-
Temple University
collaborator OTHER -
Drexel University
lead OTHER
Principal Investigators
-
Peter A Lewin, PhD · Drexel University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-01-31
- Primary Completion
- 2022-03-31
- Completion
- 2023-03-31
Countries
- United States
Study Locations
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