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This pilot study hypothesizes that use of the Regenesis Provant Wound Therapy System (a radiofrequency device) twice daily over venous stasis ulcers (wounds thought to occur due to improper functioning of valves in the veins, usually of the legs) will result in increased rates of healing and a larger proportion of completely healed wounds after 12 weeks of therapy compared to wounds treated identically using a Provant device that is not activated to emit radiofrequency.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Venous Stasis Ulcers
Provant Device (Wound Therapy System), Provant Device - Inactive
VA Long Beach Healthcare System
Southern California Institute for Research and Education
Published on BioPortfolio: 2014-07-23T21:11:05-0400
A study to demonstrate the effectiveness of PEMF treatment compared to sham treatment in changing Vibration Perception Threshold (VPT) and Thermal Sensory (QST) in patients with diabetic p...
This study is designed to evaluate the effectiveness of the Provant Therapy System in improving localized nerve growth and skin perfusion in subjects with painful peripheral diabetic neuro...
The study is an open-label, non-controlled study of the safety and effectiveness of investigator determined Provant therapy in subjects with pain and/or edema from various pain etiologies....
Part A of this trial is a multi-center, prospective, double-blinded, sham-controlled, randomized clinical trial. Part A will evaluate PEMF treatment compared to sham treatment in patients ...
A Randomized, Sham-Controlled, Double-Blind, Crossover Study to Evaluate Pulsed Electromagnetic Field (PEMF) Therapy on Pain Sensitivity to Different Qualities of Experimentally Induced Pain in Subjects With Painful Peripheral Diabetic Neuropathy
Evaluate the effectiveness of the Provant Therapy System compared to sham on pain sensitivity and nervous system response to various qualities of experimentally induced pain in the upper a...
Negative-pressure wound therapy has been widely adopted to reduce the complexity of treating a broad range of acute and chronic wounds. However, its cost is high. The objective of this study was to ev...
The Food and Drug Administration (FDA or we) is classifying the irrigating wound retractor device into class II (special controls). The special controls that apply to the device type are identified in...
The Food and Drug Administration (FDA or we) is classifying the computerized behavioral therapy device for psychiatric disorders into class II (special controls). The special controls that apply to th...
An open abdomen complicated with small-bowel fistulae becomes a complex wound for local infection, systemic sepsis and persistent soiling irritation by intestinal content. While controlling the fistul...
A new proprietary negative pressure wound device has been developed to apply negative pressure therapy to closed wounds (Closed-NPWT). We postulated that Closed-NPWT management of contaminated and dir...
Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.
Device designed to wear externally to support muscular skeletal system in various movements such as RANGE OF MOTIONS; WEIGHT-BEARING; GAIT; and LOCOMOTION.
Removal of a MEDICAL DEVICE from the market due to a problem occurring in the manufacture or distribution of the product.
The shifting in position or location of an INTRAUTERINE DEVICE from its original placement.
Removal of an implanted therapeutic or prosthetic device.
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...
Health care (or healthcare) is the diagnosis, treatment, and prevention of disease, illness, injury, and other physical and mental impairments in humans. Health care is delivered by practitioners in medicine, chiropractic, dentistry, nursing, pharmacy, a...