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Sponsored by: |
Regenesis Biomedical, Inc. |
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Information provided by: | Regenesis Biomedical, Inc. |
ClinicalTrials.gov Identifier: | NCT00761176 |
The objective of this study is to compare the reduction in wound surface areas between patients with diabetic ulcers utilizing Provant's pulsed radio frequency energy therapy (PRFE) as an adjunct to standardized basic wound care to those utilizing standardized basic wound care alone.
Condition | Intervention |
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Diabetic Foot Ulcers |
Device: The Provant Wound Therapy System |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Single Center Controlled Feasibility Study Comparing Standardized Basic Wound Care to the Provant® Wound Therapy System as an Adjunct to Standardized Basic Wound Care With a Primary Focus on Wound Surface Area Reduction in Diabetic Plantar Foot Wounds |
Estimated Enrollment: | 30 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
According to the American Diabetes Association (ADA), there are approximately 20.8 million people in the US with diabetes or 7% of the population (1). A significant number of the diabetic population is prone to pedal ulceration and estimates reveal that 15-20% of this population will develop a foot ulcer in their lifetime.
Treatment of diabetic foot ulcerations have posed a problem to healthcare providers for many years. The literature describes many different modalities for direct wound treatment strategies. Most of these treatments rely on the timely application of biological dressings, offloading of the wound, regular (and often inconvenient) visits to the doctor, and most important, compliance by the patient. It is not uncommon for such wounds to be present for greater than six months, despite use of debridement, off-loading and other basic wound care techniques, before presenting for advanced therapy.
Provant has been selected for study because:
This study will assess as an endpoints:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rick Isenberg, MD | 4809704970 | isenberg@regenesisbiomedical.com |
Contact: Regina Ponder, JD | 4809704970 | ponder@regenesisbiomedical.com |
United States, North Carolina | |
Winston - Salem Outpatient Clinic | Recruiting |
Winston - Salem, North Carolina, United States, 27103 | |
Contact: Mike Wilson 336-768-3296 ext 1496 michael.wilson9@med.va.gov | |
Principal Investigator: Mike Wilson, DPM |
Principal Investigator: | Mike Wilson, DPM | Winston - Salem Outpatient Clinic, WG Hefner VAMC |
Responsible Party: | Regenesis Biomedical, Inc. ( Regina Ponder, Director of Clinical Research ) |
Study ID Numbers: | RGI-08-08-1 |
Study First Received: | September 25, 2008 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00761176 |
Health Authority: | United States: Institutional Review Board |
The study will focus on recalcitrant diabetic foot ulcers that have been present for greater than thirty days. |
Foot Ulcer Skin Diseases Diabetic Neuropathies Ulcer Vascular Diseases Diabetes Mellitus Endocrine System Diseases |
Foot Diseases Diabetic Angiopathies Endocrinopathy Skin Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |
Pathologic Processes Cardiovascular Diseases |