A Pilot Diabetic Foot Ulcer Study
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- The incidence of wounds reaching complete closure [ Time Frame: approximate one year ] [ Designated as safety issue: Yes ]
- The time to complete wound closure percentage reduction in wound area, percentage reduction in wound volume, and rate of healing mm2/day and mm3/day. [ Time Frame: approximate one year ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2008|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
sham of device
Device: The Provant Wound Therapy System
The Provant Wound Therapy System is a safe adjuvant non-invasive medical device.
Other Name: Radio frequency generator devices
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:
- It is already indicated for the adjunctive palliative treatment of postoperative pain and edema in superficial soft tissue.
- It is a non-invasive wound treatment system which utilizes a proprietary PRFE signal which is hypothesized to trigger the release of endogenous growth factors that induce mitosis through accelerating the cell cycle, using a Ca+2 mediated pathway. The result is a significant increase in the rate of cell replication.
- It has also been shown that PRFE triggers a genetic sequence or cascade of 'wound repair' genes critical for the four stages of wound healing: inflammation, granulation, epithelialization, and remodeling.
- It has been utilized in the VA Health System since 2004 with no serious adverse events attributable to the device.
This study will assess as an endpoints:
- Primary - the incidence of wounds reaching complete closure, and
- Secondary - the time to complete wound closure percentage reduction in wound area, percentage reduction in wound volume, and rate of healing mm2/day and mm3/day.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761176
|United States, North Carolina|
|Winston - Salem Outpatient Clinic|
|Winston - Salem, North Carolina, United States, 27103|
|Principal Investigator:||Mike Wilson, DPM||Winston - Salem Outpatient Clinic, WG Hefner VAMC|